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    Clinical Trial Results:
    A Multicenter, 10-Week, Randomized, Double-Blind Study Of Sertraline And Placebo In Children And Adolescents With Posttraumatic Stress Disorder (PTSD)

    Summary
    EudraCT number
    		 2014-004162-17
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    18 Jul 2007

    Results information
    Results version number
    		 v2(current)
    This version publication date
    17 Jun 2016
    First version publication date
    29 Jul 2015
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    typographical error was observed in one of the outcome measure titles

    Trial information

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    Trial identification
    Sponsor protocol code
    A0501061
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00150306
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Clinical Trials.gov Call Center, Pfizer Inc, 001 8007181021, ClinicalTrials.govCallCenter@pfizer.com
    Scientific contact
    Clinical Trials.gov Call Center, Pfizer Inc, 001 8007181021, ClinicalTrials.govCallCenter@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 May 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jul 2007
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the safety and efficacy of sertraline compared to placebo in children and adolescents (6 to 17 years of age) who are outpatients with the diagnosis of Posttraumatic Stress Disorder (PTSD).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Nov 2002
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 129
    Worldwide total number of subjects
    129
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    74
    Adolescents (12-17 years)
    55
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted in United States at 30 centers. The study started on 15 November 2002 and completed on 18 July 2007.

    Pre-assignment
    Screening details
    		 A total 204 subjects were screened, 131 subjects were assigned to treatment and 129 subjects received treatment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sertraline
    Arm description
    		 Subjects received daily 25 milligram (mg) dose of sertraline once daily. The 25 mg dose was maintained until the end of Week 1 visit. At that visit, the dose was increased to 50 mg daily and maintained at this level until the end of Week 3 visit. Thereafter, it was permissible for dose increases to be made in 50 mg increments for 2-week intervals up to a maximum of 200 mg daily, based on clinical response and in the absence of dose-limiting adverse events (AEs).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sertraline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received daily 25 mg dose of sertraline once daily. The 25-mg dose was maintained until the end of Week 1 visit. At that visit, the dose was increased to 50 mg daily and maintained at this level until the end of Week 3 visit. Thereafter, it was permissible for dose increases to be made in 50 mg increments for 2-week intervals up to a maximum of 200 mg daily, based on clinical response and in the absence of dose-limiting AEs.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received matching placebo once daily for 10 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received matching placebo once daily for 10 weeks.

    Number of subjects in period 1
    		Sertraline Placebo
    Started
    67
    62
    Completed
    47
    51
    Not completed
    20
    11
         Adverse Event
    5
    2
         Other
    6
    3
         Lost to follow-up
    8
    5
         Lack of efficacy
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Sertraline
    Reporting group description
    		 Subjects received daily 25 milligram (mg) dose of sertraline once daily. The 25 mg dose was maintained until the end of Week 1 visit. At that visit, the dose was increased to 50 mg daily and maintained at this level until the end of Week 3 visit. Thereafter, it was permissible for dose increases to be made in 50 mg increments for 2-week intervals up to a maximum of 200 mg daily, based on clinical response and in the absence of dose-limiting adverse events (AEs).

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching placebo once daily for 10 weeks.

    Reporting group values
    		 Sertraline Placebo Total
    Number of subjects
    		 67 62 129
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 10.8 ± 3.2 11.2 ± 3.6 -
    Gender categorical
    Units: Subjects
        Female
    		 40 38 78
        Male
    		 27 24 51
    UCLA PTSD-I Total Symptom Score at Baseline
    The UCLA PTSD­I was clinician ­rated scale that consists of 22 items.The scale score for each item from 0 to 4,giving a possible score range of 0­-68,with higher value indicating more frequency of symptoms. ITT population for efficacy analysis included those safety evaluable subjects who had baseline and post-randomization efficacy data. Safety evaluable subjects were defined as subjects who took atleast 1 dose of study drug and provided any follow up inforamtion.Number of subjects evaluable for UCLA PTSD-I Total Symptom Score at Baseline for sertraline and placebo was 63 and 54,respectively.
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 43.5 ± 8.5 41.6 ± 8.9 -

    End points

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    End points reporting groups
    Reporting group title
    Sertraline
    Reporting group description
    		 Subjects received daily 25 milligram (mg) dose of sertraline once daily. The 25 mg dose was maintained until the end of Week 1 visit. At that visit, the dose was increased to 50 mg daily and maintained at this level until the end of Week 3 visit. Thereafter, it was permissible for dose increases to be made in 50 mg increments for 2-week intervals up to a maximum of 200 mg daily, based on clinical response and in the absence of dose-limiting adverse events (AEs).

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching placebo once daily for 10 weeks.

    Primary: Change From Baseline in the University of California at Los Angeles Post-Traumatic Stress Disorder Index (UCLA PTSD-I) for Diagnostic and Statistical Manual- IV (DSM-IV) Total Symptom Score at Endpoint

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    End point title
    		 Change From Baseline in the University of California at Los Angeles Post-Traumatic Stress Disorder Index (UCLA PTSD-I) for Diagnostic and Statistical Manual- IV (DSM-IV) Total Symptom Score at Endpoint
    End point description
    The UCLA PTSD-I was a clinician-rated scale that consists of 22 items. It assesses, in a direct, semistructured interview, the frequency of symptoms of PTSD as well as associated features. Each item was scored on a 5-point Likert scale (none, little, some, much, and most of the time) and the total symptom score was computed from 17 PTSD symptom frequency items. The scale score for each item from 0 to 4, giving a possible score range of 0-68, with higher value indicating more frequency of symptoms. Intent-to-treat (ITT) subject population for efficacy analysis included those safety evaluable subjects who had baseline and post-randomization efficacy data. Safety evaluable subjects were defined as subjects who took atleast 1 dose of study drug and provided any follow up information.
    End point type
    Primary
    End point timeframe
    Baseline, Endpoint (last assessment for a subject up to Week 10)
    End point values
    		 Sertraline Placebo
    Number of subjects analysed
    63
    54
    Units: Units on a scale
        least squares mean (standard error)
    -17 ± 2.1
    -20.3 ± 2.4
    Statistical analysis title
    		 UCLA PTSD-I Total Symptom Score at endpoint
    Statistical analysis description
    Analyses were based on ANOVA with model terms of treatment group, age strata, and center for endpoint.
    Comparison groups
    Sertraline v Placebo
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.212
    Method
    		 ANOVA
    Confidence interval

    Secondary: Change From Baseline in University of California at Los Angeles Post-Traumatic Stress Disorder Index (UCLA PTSD-I) Symptom Cluster Scores at Endpoint

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    End point title
    		 Change From Baseline in University of California at Los Angeles Post-Traumatic Stress Disorder Index (UCLA PTSD-I) Symptom Cluster Scores at Endpoint
    End point description
    UCLA PTSD-Rl symptom clusters of re-experiencing, avoidance, and increased arousal;as well as associated features sub-factor score. Symptom cluster of re-experiencing:sum of individual items 2, 3, 5, 6, 18; score range=0-20, higher value=more re-experiencing.Symptom cluster of avoidance for children:sum of individual items 7, 8, 9, 15, 17, 19a,higher score from items 10 or 11.For adolescents, item 19a score was replaced by the higher of items 19a or 19b;score range=0-28,higher value=more avoidance.Symptom cluster of increased arousal for children:sum of individual items 1, 4a, 12, 13, 16.For adolescents, item 4a was replaced by the higher of items 4a or 4b; score range=0-20,higher score=increased arousal. Associated feature sub-factor score was sum of items 14 and 20;score range=0-8, higher score=worsening. The interim analysis showed that sertraline was unlikely to separate from placebo at study end.The study was terminated early, and only safety and primary parameter were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Endpoint (last assessment for a subject up to Week 10)
    End point values
    		 Sertraline Placebo
    Number of subjects analysed
    0 [1]
    0 [2]
    Units: Units on a scale
        least squares mean (standard error)
    ±
    ±
    Notes
    [1] - The study was terminated hence data was not analyzed.
    [2] - The study was terminated hence data was not analyzed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in University of California at Los Angeles Post-Traumatic Stress Disorder Index (UCLA PTSD-I) Individual Item Scores at Endpoint

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    End point title
    		 Change From Baseline in University of California at Los Angeles Post-Traumatic Stress Disorder Index (UCLA PTSD-I) Individual Item Scores at Endpoint
    End point description
    The UCLA PTSD-I was a clinician-rated scale that consists of 22 items. It assesses, in a direct, semistructured interview, the frequency of symptoms of PTSD as well as associated features. Each item was scored on a 5-point Likert scale (none, little, some, much, and most of the time). The individual item score ranges from 0-4, with higher indicating long duration of symptom. The interim analysis showed that sertraline treatment was unlikely to separate from placebo at end of study it was decided to terminate the study early, and only safety and the primary efficacy parameter were analyzed and reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Endpoint (last assessment for a subject up to Week 10)
    End point values
    		 Sertraline Placebo
    Number of subjects analysed
    0 [3]
    0 [4]
    Units: Units on a scale
        least squares mean (standard error)
    ±
    ±
    Notes
    [3] - The study was terminated hence data was not analyzed.
    [4] - The study was terminated hence data was not analyzed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Total Endorsed Symptom Score and Total Endorsed Cluster Symptom Score at Endpoint

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    End point title
    		 Change From Baseline in the Total Endorsed Symptom Score and Total Endorsed Cluster Symptom Score at Endpoint
    End point description
    The total endorsed symptom score was defined as sum of UCLA PTSD-I individual items with a score of either 3 (much time) or 4 (most time) for each subject at baseline and endpoint. The score ranges from 0-57 or 0-68, with higher value indicating long duration of symptoms. The total endorsed re-experiencing symptom score, total endorsed avoidance symptom score, and total endorsed increased arousal symptom score. The total endorsed cluster symptom score was defined as sum of UCLA PTSD-RI individual items with a score of either 3 (much time) or 4 (most time) within that symptom cluster for each subject at baseline and endpoint. The score ranges from 0-57 or 0-68, with higher value indicating more clustered symptoms. The interim analysis showed that sertraline treatment was unlikely to separate from placebo at end of study it was decided to terminate the study early, and only safety and the primary efficacy parameter were analyzed and reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Endpoint (last assessment for a subject up to Week 10)
    End point values
    		 Sertraline Placebo
    Number of subjects analysed
    0 [5]
    0 [6]
    Units: Units on a scale
        least squares mean (standard error)
    ±
    ±
    Notes
    [5] - The study was terminated hence data was not analyzed.
    [6] - The study was terminated hence data was not analyzed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Child Stress Disorder Checklist (CSDC) Total Score and Symptom Clusters at Endpoint

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    End point title
    		 Change From Baseline in the Child Stress Disorder Checklist (CSDC) Total Score and Symptom Clusters at Endpoint
    End point description
    The CSDC was a 30-item parent/guardian-rated scale that evaluates PTSD symptoms and functional impairment. CSDC total score and symptom clusters of: re-experiencing symptom cluster which was to be calculated as the sum of items 1, 3, 12, 19, 22, 23, and 25; avoidance symptom cluster was calculated as the sum of items 5, 14, 21, 28, and 30; numbing and dissociation symptom cluster was calculated as the sum of items 4, 7, 9, 16, 18, 20, 26, and 27; increased arousal symptom cluster was calculated as the sum of items 2, 6, 8, 13, 17, and 29; as well as sub-factor score of impairment in function were calculated as the sum of items 10, 11, 15, and 24. The interim analysis showed that sertraline treatment was unlikely to separate from placebo at end of study it was decided to terminate the study early, and only safety and the primary efficacy parameter were analyzed and reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Endpoint (last assessment for a subject up to Week 10)
    End point values
    		 Sertraline Placebo
    Number of subjects analysed
    0 [7]
    0 [8]
    Units: Units on a scale
        least squares mean (standard error)
    ±
    ±
    Notes
    [7] - The study was terminated hence data was not analyzed.
    [8] - The study was terminated hence data was not analyzed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Child Stress Disorder Checklist (CSDC) Individual Item Scores at Endpoint

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    End point title
    		 Change From Baseline in Child Stress Disorder Checklist (CSDC) Individual Item Scores at Endpoint
    End point description
    The CSDC was a 30-item parent/guardian-rated scale that evaluates PTSD symptoms and functional impairment. The interim analysis showed that sertraline treatment was unlikely to separate from placebo at end of study it was decided to terminate the study early, and only safety and the primary efficacy parameter were analyzed and reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Endpoint (last assessment for a subject up to Week 10)
    End point values
    		 Sertraline Placebo
    Number of subjects analysed
    0 [9]
    0 [10]
    Units: Units on a scale
        least squares mean (standard error)
    ±
    ±
    Notes
    [9] - The study was terminated hence data was not analyzed.
    [10] - The study was terminated hence data was not analyzed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Clinical Global Impression Severity of Illness (CGI-S) Score at Endpoint

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    End point title
    		 Change From Baseline in the Clinical Global Impression Severity of Illness (CGI-S) Score at Endpoint
    End point description
    The CGI-S scale are clinician-rated measures that assess the subject’s severity of illness . For CGI-S, the investigator was to rate the subject in response to the following question:“Considering your total clinical experience with PTSD, how mentally ill is the subject at this time?” The ratings were: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill. The CGI-S scale score ranges from 0 to 7, with higher value indicating no improvement or more severe illness condition. The interim analysis showed that sertraline treatment was unlikely to separate from placebo at end of study it was decided to terminate the study early, and only safety and the primary efficacy parameter were analyzed and reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Endpoint (last assessment for a subject up to Week 10)
    End point values
    		 Sertraline Placebo
    Number of subjects analysed
    0 [11]
    0 [12]
    Units: Units on a scale
        least squares mean (standard error)
    ±
    ±
    Notes
    [11] - The study was terminated hence data was not analyzed.
    [12] - The study was terminated hence data was not analyzed.
    No statistical analyses for this end point

    Secondary: Clinical Global Impression Improvement (CGI-I) scores at the Endpoint

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    End point title
    		 Clinical Global Impression Improvement (CGI-I) scores at the Endpoint
    End point description
    The CGI-I scales are clinician-rated measures that assess the subject’s ill global improvement, respectively. For CGI-I, the investigator was to rate the subject in response to the following question:“Compared to the subject’s condition at Baseline, how much has he/she changed?” He or she was to rate the global improvement whether or not, in his or her judgment, it was due entirely to drug treatment. The ratings were: 1= very much improved; 2= much improved; 3= minimally improved; 4= no change; 5= minimally worse; 6= much worse; and 7= very much worse. The CGI-I scale score ranges from 0 to 7, with higher value indicating no improvement or more worse condition. The interim analysis showed that sertraline treatment was unlikely to separate from placebo at end of study it was decided to terminate the study early, and only safety and the primary efficacy parameter were analyzed and reported.
    End point type
    Secondary
    End point timeframe
    Endpoint (last assessment for a subject up to Week 10)
    End point values
    		 Sertraline Placebo
    Number of subjects analysed
    0 [13]
    0 [14]
    Units: Units on a scale
        least squares mean (standard error)
    ±
    ±
    Notes
    [13] - The study was terminated hence data was not analyzed.
    [14] - The study was terminated hence data was not analyzed.
    No statistical analyses for this end point

    Secondary: Percentage of Responders Based on Clinical Global Impression Improvement (CGI-I) Scores at Endpoint

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    End point title
    		 Percentage of Responders Based on Clinical Global Impression Improvement (CGI-I) Scores at Endpoint
    End point description
    Responders: percentage of subjects with CGI-I ≤ 2 (“very much” or “much” improved) at endpoint. The interim analysis showed that sertraline treatment was unlikely to separate from placebo at end of study it was decided to terminate the study early, and only safety and the primary efficacy parameter were analyzed and reported.
    End point type
    Secondary
    End point timeframe
    Endpoint (End of Week 10)
    End point values
    		 Sertraline Placebo
    Number of subjects analysed
    0 [15]
    0 [16]
    Units: Percentage of subjects
        number (not applicable)
    Notes
    [15] - The study was terminated hence data was not analyzed.
    [16] - The study was terminated hence data was not analyzed.
    No statistical analyses for this end point

    Secondary: Percentage of Remitters Based on the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children - Present and Lifetime Version (K-SADS-PL) at Endpoint

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    End point title
    		 Percentage of Remitters Based on the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children - Present and Lifetime Version (K-SADS-PL) at Endpoint
    End point description
    K-SADS-PL as the diagnostic interview was used to assesses the presence of symptoms of PTSD, as well as other psychiatric disorders, on the basis of DSM-IV diagnostic criteria. Remitters: percentage of subjects who no longer meet criteria for the diagnosis of PTSD as assessed by the K-SADS-PL at endpoint. The interim analysis showed that sertraline treatment was unlikely to separate from placebo at end of study it was decided to terminate the study early, and only safety and the primary efficacy parameter were analyzed and reported.
    End point type
    Secondary
    End point timeframe
    Endpoint (End of Week 10)
    End point values
    		 Sertraline Placebo
    Number of subjects analysed
    0 [17]
    0 [18]
    Units: Percentage of subjects
        number (not applicable)
    Notes
    [17] - The study was terminated hence data was not analyzed.
    [18] - The study was terminated hence data was not analyzed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Investigator Rated Children’s Depression Rating Scale Revised (CDRS-R ) Total Score at Endpoint

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    End point title
    		 Change From Baseline in the Investigator Rated Children’s Depression Rating Scale Revised (CDRS-R ) Total Score at Endpoint
    End point description
    The CDRS-R was a clinician-rated scale that consists of 17 items and assesses the severity of symptoms of depression. The first 14 items were symptom ratings and the remaining 3 items were rated on the basis of the subject’s nonverbal behavior (i.e., depressed facial affect, listless speech, hypoactivity). The 17 items of the CDRS-R were scored from 1 to 5 for sleep disturbance, appetite disturbance and listless speech items, and from 1 to 7 for the remaining 14 items. The CDRS-R score ranges from 0 to 113, with higher score range indicating more severe symptom of depression. The interim analysis showed that sertraline treatment was unlikely to separate from placebo at end of study it was decided to terminate the study early, and only safety and the primary efficacy parameter were analyzed and reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Endpoint (last assessment for a subject up to Week 10)
    End point values
    		 Sertraline Placebo
    Number of subjects analysed
    0 [19]
    0 [20]
    Units: Units on a scale
        least squares mean (standard error)
    ±
    ±
    Notes
    [19] - The study was terminated hence data was not analyzed.
    [20] - The study was terminated hence data was not analyzed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score at Endpoint

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    End point title
    		 Change From Baseline in the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score at Endpoint
    End point description
    The PQ-LES-Q was a self-report measure that assesses the quality of life in children and adolescents. It was derived from the adult version of the scale, the Quality of Life Enjoyment and Satisfaction Questionnaire and has been reworded to capture events more relevant to a child or adolescent. The 15 items of the scale were rated on a scale of: 1= very poor; 2= poor; 3= fair; 4= good; 5= very good. The PQ-LES-Q score ranges from 0-75, with higher score indicating better quality of life. The interim analysis showed that sertraline treatment was unlikely to separate from placebo at end of study it was decided to terminate the study early, and only safety and the primary efficacy parameter were analyzed and reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Endpoint (last assessment for a subject up to Week 10)
    End point values
    		 Sertraline Placebo
    Number of subjects analysed
    0 [21]
    0 [22]
    Units: Units on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [21] - The study was terminated hence data was not analyzed.
    [22] - The study was terminated hence data was not analyzed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment emergent adverse events are reported from time of first dose of study treatment up to 7 days after last dose of study treatment
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Sertraline
    Reporting group description
    		 Subjects received daily 25 mg dose of sertraline once daily. The 25 mg dose was maintained until the end of Week 1 visit. At that visit, the dose was increased to 50 mg daily and maintained at this level until the end of Week 3 visit. Thereafter, it was permissible for dose increases to be made in 50 mg increments for 2-week intervals up to a maximum of 200 mg daily, based on clinical response and in the absence of dose-limiting AEs.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching placebo once daily for 10 weeks.

    Serious adverse events
    		 Sertraline Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 62 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    Psychomotor hyperactivity
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conversion disorder
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Varicella
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Sertraline Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    51 / 67 (76.12%)
    47 / 62 (75.81%)
    General disorders and administration site conditions
    Crying
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    3 / 67 (4.48%)
    2 / 62 (3.23%)
         occurrences all number
    4
    2
    Fatigue
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Thirst
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    1 / 67 (1.49%)
    2 / 62 (3.23%)
         occurrences all number
    1
    3
    Reproductive system and breast disorders
    Breast pain
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Dysmenorrhoea
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    0
    4
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 67 (1.49%)
    2 / 62 (3.23%)
         occurrences all number
    1
    2
    Cough
         subjects affected / exposed
    4 / 67 (5.97%)
    0 / 62 (0.00%)
         occurrences all number
    5
    0
    Nasal congestion
         subjects affected / exposed
    2 / 67 (2.99%)
    1 / 62 (1.61%)
         occurrences all number
    2
    1
    Oropharyngeal pain
         subjects affected / exposed
    4 / 67 (5.97%)
    2 / 62 (3.23%)
         occurrences all number
    4
    2
    Rhinitis allergic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 62 (0.00%)
         occurrences all number
    2
    0
    Sinus congestion
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Tonsillar hypertrophy
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Throat irritation
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Upper respiratory tract congestion
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    2 / 67 (2.99%)
    2 / 62 (3.23%)
         occurrences all number
    2
    2
    Abnormal dreams
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Anxiety
         subjects affected / exposed
    2 / 67 (2.99%)
    1 / 62 (1.61%)
         occurrences all number
    2
    1
    Attention deficit/hyperactivity disorder
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Encopresis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Hallucination, visual
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Impulsive behaviour
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Irritability
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 62 (1.61%)
         occurrences all number
    1
    1
    Insomnia
         subjects affected / exposed
    7 / 67 (10.45%)
    8 / 62 (12.90%)
         occurrences all number
    9
    9
    Mood altered
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Mood swings
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Morose
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Nervousness
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Nightmare
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    0
    2
    Panic attack
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Self injurious behaviour
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Suicidal ideation
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 62 (0.00%)
         occurrences all number
    2
    0
    Tic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Tearfulness
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Heart rate decreased
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Weight decreased
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Red blood cell morphology abnormal
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 62 (1.61%)
         occurrences all number
    1
    1
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Contusion
         subjects affected / exposed
    3 / 67 (4.48%)
    1 / 62 (1.61%)
         occurrences all number
    3
    1
    Burns second degree
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Fall
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Laceration
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Foot fracture
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Ligament sprain
         subjects affected / exposed
    2 / 67 (2.99%)
    3 / 62 (4.84%)
         occurrences all number
    2
    3
    Limb injury
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Torus fracture
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Skin abrasion
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 62 (1.61%)
         occurrences all number
    1
    1
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Palpitations
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Tachycardia
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Convulsion
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Disturbance in attention
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Dizziness
         subjects affected / exposed
    3 / 67 (4.48%)
    5 / 62 (8.06%)
         occurrences all number
    3
    6
    Headache
         subjects affected / exposed
    17 / 67 (25.37%)
    12 / 62 (19.35%)
         occurrences all number
    22
    12
    Loss of consciousness
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Migraine
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Psychomotor hyperactivity
         subjects affected / exposed
    6 / 67 (8.96%)
    1 / 62 (1.61%)
         occurrences all number
    7
    1
    Somnolence
         subjects affected / exposed
    3 / 67 (4.48%)
    0 / 62 (0.00%)
         occurrences all number
    3
    0
    Speech disorder
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Hypochromasia
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Lymphadenitis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Microcytosis
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Macrocytosis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Ear canal erythema
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Ear congestion
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Ear discomfort
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Ear pain
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 62 (1.61%)
         occurrences all number
    3
    1
    Abdominal pain
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 62 (1.61%)
         occurrences all number
    2
    1
    Abdominal pain upper
         subjects affected / exposed
    8 / 67 (11.94%)
    10 / 62 (16.13%)
         occurrences all number
    10
    12
    Abdominal tenderness
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Constipation
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 62 (0.00%)
         occurrences all number
    2
    0
    Diarrhoea
         subjects affected / exposed
    6 / 67 (8.96%)
    3 / 62 (4.84%)
         occurrences all number
    6
    3
    Flatulence
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Dry mouth
         subjects affected / exposed
    5 / 67 (7.46%)
    0 / 62 (0.00%)
         occurrences all number
    5
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    9 / 67 (13.43%)
    6 / 62 (9.68%)
         occurrences all number
    11
    8
    Toothache
         subjects affected / exposed
    3 / 67 (4.48%)
    1 / 62 (1.61%)
         occurrences all number
    3
    1
    Vomiting
         subjects affected / exposed
    9 / 67 (13.43%)
    3 / 62 (4.84%)
         occurrences all number
    10
    3
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Blister
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Dry skin
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Ecchymosis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Swelling face
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Rash papular
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Enuresis
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Haematuria
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Arthralgia
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    0
    3
    Myalgia
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 62 (1.61%)
         occurrences all number
    1
    4
    Pain in extremity
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    0
    2
    Infections and infestations
    Gastroenteritis viral
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 67 (1.49%)
    2 / 62 (3.23%)
         occurrences all number
    1
    2
    Influenza
         subjects affected / exposed
    3 / 67 (4.48%)
    2 / 62 (3.23%)
         occurrences all number
    3
    2
    Localised infection
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 67 (2.99%)
    5 / 62 (8.06%)
         occurrences all number
    3
    7
    Otitis externa
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Otitis media
         subjects affected / exposed
    1 / 67 (1.49%)
    2 / 62 (3.23%)
         occurrences all number
    1
    2
    Otitis media acute
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Paronychia
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis streptococcal
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 62 (0.00%)
         occurrences all number
    2
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
         subjects affected / exposed
    3 / 67 (4.48%)
    1 / 62 (1.61%)
         occurrences all number
    3
    1
    Tinea infection
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 67 (5.97%)
    3 / 62 (4.84%)
         occurrences all number
    4
    3
    Urinary tract infection
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Viral infection
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 62 (0.00%)
         occurrences all number
    2
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    3 / 67 (4.48%)
    2 / 62 (3.23%)
         occurrences all number
    3
    2
    Increased appetite
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Since the interim analysis showed that sertraline treatment was unlikely to separate from placebo at end of study it was decided to terminate the study early, and only safety and the primary efficacy parameter were analyzed and reported.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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