Clinical Trial Results:
Interventional, open-label, flexible-dose extension study of aripiprazole once-monthly in patients with schizophrenia
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Summary
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EudraCT number |
2012-003239-47 |
Trial protocol |
CZ DE ES IT EE SE FR |
Global end of trial date |
19 Mar 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
03 Apr 2016
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First version publication date |
03 Apr 2016
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
14724B
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01959035 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
H. Lundbeck A/S
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Sponsor organisation address |
Ottiliavej 9, Valby, Denmark, 2500
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Public contact |
LundbeckClinicalTrials@lundbeck.com, H. Lundbeck A/S, LundbeckClinicalTrials@lundbeck.com
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Scientific contact |
LundbeckClinicalTrials@lundbeck.com, H. Lundbeck A/S, LundbeckClinicalTrials@lundbeck.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
19 Mar 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
19 Mar 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
19 Mar 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To obtain information on the safety, tolerability and effectiveness of aripiprazole once-monthly in a manner consistent with its intended use in everyday clinical practice in patients with schizophrenia who completed Study 14724A / NCT01795547)
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Protection of trial subjects |
The trial was conducted in accordance with the Declaration of Helsinki (2008) and ICH Good Clinical Practice (1996)
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
30 Oct 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 12
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Country: Number of subjects enrolled |
Sweden: 3
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Country: Number of subjects enrolled |
Czech Republic: 11
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Country: Number of subjects enrolled |
Estonia: 15
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Country: Number of subjects enrolled |
France: 6
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Country: Number of subjects enrolled |
Germany: 12
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Country: Number of subjects enrolled |
Italy: 10
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Country: Number of subjects enrolled |
Canada: 1
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Country: Number of subjects enrolled |
United States: 18
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Worldwide total number of subjects |
88
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EEA total number of subjects |
69
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
88
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||
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Pre-assignment
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Screening details |
Subjects who met each of the inclusion and none of the exclusion criteria were eligible to participate in the study | ||||||||||||||||
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Period 1
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Period 1 title |
Overall Period
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Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||
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Arms
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Arm title
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Aripiprazole | ||||||||||||||||
Arm description |
Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Aripiprazole
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for prolonged-release suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
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Baseline characteristics reporting groups
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Reporting group title |
Aripiprazole
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Reporting group description |
Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Aripiprazole
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Reporting group description |
Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline | ||
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End point title |
Number of treatment emergent adverse events (TEAEs) [1] | ||||||
End point description |
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End point type |
Primary
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End point timeframe |
From baseline and up to 24 weeks and the 4-week safety follow-up
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses were performed, it was just a calculation |
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| No statistical analyses for this end point | |||||||
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End point title |
Change From Baseline to Week 24 in SWN-S Total Score | ||||||||
End point description |
The Subjective Well-Being under Neuroleptic Treatment - Short Version (SWN-S) is a patient-rated scale designed to measure subjective effects of neuroleptic drugs to psychopathology, quality of life, and compliance over the past 7 days. The 20 items (10 positive and 10 negative statements) are grouped in 5 subscales (mental functioning, selfcontrol, physical functioning, emotional regulation and social integration). Each subscale contains 4 items. Each item was rated on a six-point Likert scale, from not at all to very much. A score was calculated for each subscale, and the total score ranged from 20 to 120, where the higher score indicated better well-being.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 24
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline to Week 24 in CGI-S Score | ||||||||
End point description |
Clinical Global Impression - Severity of Illness (CGI-S) score provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).
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End point type |
Secondary
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End point timeframe |
Baseline and Week 24
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline to Week 24 in QLS Total Score | ||||||||
End point description |
The Quality of Life Scale (QLS) is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). Definitions were provided for 4 anchor points of the 7 points. Each item had a brief description of the judgement to be made and a set of suggested probes for the clinician. The total score was calculated as the sum of all 21 items giving a range of 0 to 126, where the higher score indicated normal or unimpaired functioning.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 24
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline to Week 24 in the 'Common Objects and Activities' QLS Domain Score | ||||||||
End point description |
The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Common Objects and Activities domain score was calculated as the sum of 2 items (numbers 18 and 19) giving a range of 0 to 12, where the higher score indicated less unimpaired functioning.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 24
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline to Week 24 in the 'Intrapsychic Foundations' QLS Domain Score | ||||||||
End point description |
The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Intrapsychic Foundations domain score was calculated as the sum of 7 items (numbers 13 to 17 and 20 and 21) giving a range of 0 to 42, where the higher score indicated less unimpaired functioning
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End point type |
Secondary
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End point timeframe |
Baseline and Week 24
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline to Week 24 in the 'Interpersonal Relations' QLS Domain Score | ||||||||
End point description |
The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Interpersonal Relations domain score was calculated as the sum of 8 items (numbers 1 to 8) giving a range of 0 to 48, where the higher score indicated less unimpaired functioning.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 24
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline to Week 24 in the 'Instrumental Role' QLS Domain Score | ||||||||
End point description |
The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Instrumental Role domain score was calculated as the sum of 4 items (numbers 9 to 12) giving a range of 0 to 24, where the higher score indicated less unimpaired functioning.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 24
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline to Week 24 in the TooL Total Score | ||||||||
End point description |
Tolerability and Quality of Life (TooL) is a patient-rated scale developed to measure the impact of side-effects on the quality of life in patients treated with antipsychotic medication. The TooL consists of 8 domains: mood (worry-upset), function capabilities, fatigue-weakness, weight gain, stiffness-tremor, physical restlessness, sexual dysfunction, and dizziness-nausea. Each domain was rated on a four-point scale from 1 (no impact) to 4 (maximum impact). Total scores ranged from 8 (no impact) to 32 (maximum impact).
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End point type |
Secondary
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End point timeframe |
Baseline and Week 24
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline to Week 24 in ASEX Total Score | ||||||||
End point description |
The Arizona Sexual Experience Scale (ASEX) is a five-item, patient-rated scale that evaluates a patient’s recent sexual experiences. The ASEX is used to identify individuals with sexual dysfunction. Patients were asked to assess their own experiences over the last week (for example, “How strong is your sex drive?”, “Are your orgasms satisfying?”) and respond on a six-point scale for each item. Possible total scores range from 5 to 30. Higher ASEX total scores indicate more sexual dysfunction (hypofunction).
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End point type |
Secondary
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End point timeframe |
Baseline and Week 24
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline to Week 24 in the WoRQ Total Score | ||||||||
End point description |
The Readiness for Work Questionnaire (WoRQ) is a clinician-rated scale designed to measure a schizophrenic patient’s ability to work. The WoRQ consists of 8 items: the clinician had to rate 7 statements and answer 1 question. The statements were rated on a four-point scale, from 'strongly agree', 'agree', 'disagree' or 'strongly disagree' based on all material available (for example, personal notes, medical records, input from other health professionals, family members or caregivers); and in the final item, the clinician had to indicate if the patient was ready for work or not (by indicating either 'yes' or 'no'). Lower WoRQ total scores indicate better functioning.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 24
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline to Week 12 in SWN-S Total Score | ||||||||
End point description |
The Subjective Well-Being under Neuroleptic Treatment - Short Version (SWN-S) is a patient-rated scale designed to measure subjective effects of neuroleptic drugs to psychopathology, quality of life, and compliance over the past 7 days. The 20 items (10 positive and 10 negative statements) are grouped in 5 subscales (mental functioning, selfcontrol, physical functioning, emotional regulation and social integration). Each subscale contains 4 items. Each item was rated on a six-point Likert scale, from not at all to very much. A score was calculated for each subscale, and the total score ranged from 20 to 120, where the higher score indicated better well-being.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline to Week 12 in CGI-S Score | ||||||||
End point description |
Clinical Global Impression - Severity of Illness (CGI-S) score provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline to Week 12 in QLS Total Score | ||||||||
End point description |
The Quality of Life Scale (QLS) is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). Definitions were provided for 4 anchor points of the 7 points. Each item had a brief description of the judgement to be made and a set of suggested probes for the clinician. The total score was calculated as the sum of all 21 items giving a range of 0 to 126, where the higher score indicated normal or unimpaired functioning.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline to Week 12 in the 'Common Objects and Activities' QLS Domain Score | ||||||||
End point description |
The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Common Objects and Activities domain score was calculated as the sum of 2 items (numbers 18 and 19) giving a range of 0 to 12, where the higher score indicated less unimpaired functioning.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline to Week 12 in the 'Intrapsychic Foundations' QLS Domain Score | ||||||||
End point description |
The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Intrapsychic Foundations domain score was calculated as the sum of 7 items (numbers 13 to 17 and 20 and 21) giving a range of 0 to 42, where the higher score indicated less unimpaired functioning
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline to Week 12 in the 'Interpersonal Relations' QLS Domain Score | ||||||||
End point description |
The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Interpersonal Relations domain score was calculated as the sum of 8 items (numbers 1 to 8) giving a range of 0 to 48, where the higher score indicated less unimpaired functioning.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline to Week 12 in the 'Instrumental Role' QLS Domain Score | ||||||||
End point description |
The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Instrumental Role domain score was calculated as the sum of 4 items (numbers 9 to 12) giving a range of 0 to 24, where the higher score indicated less unimpaired functioning.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline to Week 28 in the TooL Total Score | ||||||||
End point description |
Tolerability and Quality of Life (TooL) is a patient-rated scale developed to measure the impact of side-effects on the quality of life in patients treated with antipsychotic medication. The TooL consists of 8 domains: mood (worry-upset), function capabilities, fatigue-weakness, weight gain, stiffness-tremor, physical restlessness, sexual dysfunction, and dizziness-nausea. Each domain was rated on a four-point scale from 1 (no impact) to 4 (maximum impact). Total scores ranged from 8 (no impact) to 32 (maximum impact).
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline to Week 12 in ASEX Total Score | ||||||||
End point description |
The Arizona Sexual Experience Scale (ASEX) is a five-item, patient-rated scale that evaluates a patient’s recent sexual experiences. The ASEX is used to identify individuals with sexual dysfunction. Patients were asked to assess their own experiences over the last week (for example, “How strong is your sex drive?”, “Are your orgasms satisfying?”) and respond on a six-point scale for each item. Possible total scores range from 5 to 30. Higher ASEX total scores indicate more sexual dysfunction (hypofunction).
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline to Week 12 in the WoRQ Total Score | ||||||||
End point description |
The Readiness for Work Questionnaire (WoRQ) is a clinician-rated scale designed to measure a schizophrenic patient’s ability to work. The WoRQ consists of 8 items: the clinician had to rate 7 statements and answer 1 question. The statements were rated on a four-point scale, from 'strongly agree', 'agree', 'disagree' or 'strongly disagree' based on all material available (for example, personal notes, medical records, input from other health professionals, family members or caregivers); and in the final item, the clinician had to indicate if the patient was ready for work or not (by indicating either 'yes' or 'no'). Lower WoRQ total scores indicate better functioning.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| No statistical analyses for this end point | |||||||||
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End point title |
Patients Categorised As Sexually Dysfunctional Measured at Week 24 on the ASEX Scale | ||||||
End point description |
The Arizona Sexual Experience Scale (ASEX) is a five-item, patient-rated scale that evaluates a patient's recent sexual experiences. The ASEX is used to identify individuals with sexual dysfunction. Patients were asked to assess their own experiences over the last week (for example, "How strong is your sex drive?", "Are your orgasms satisfying?") and respond on a six-point scale for each item. Possible total scores range from 5 to 30. Higher ASEX total scores indicate more sexual dysfunction (hypofunction). The presence of sexual dysfunction based on the ASEX scale was defined as an ASEX total score of ≥19, or a score of ≥5 on any item, or a score of ≥4 on any 3 items
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End point type |
Secondary
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End point timeframe |
Week 24
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| No statistical analyses for this end point | |||||||
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End point title |
Patients Categorised As Sexually Dysfunctional Measured at Week 12 on the ASEX Scale | ||||||
End point description |
The Arizona Sexual Experience Scale (ASEX) is a five-item, patient-rated scale that evaluates a patient's recent sexual experiences. The ASEX is used to identify individuals with sexual dysfunction. Patients were asked to assess their own experiences over the last week (for example, "How strong is your sex drive?", "Are your orgasms satisfying?") and respond on a six-point scale for each item. Possible total scores range from 5 to 30. Higher ASEX total scores indicate more sexual dysfunction (hypofunction). The presence of sexual dysfunction based on the ASEX scale was defined as an ASEX total score of ≥19, or a score of ≥5 on any item, or a score of ≥4 on any 3 items.
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End point type |
Secondary
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End point timeframe |
week 12
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| No statistical analyses for this end point | |||||||
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Adverse events information
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Timeframe for reporting adverse events |
First dose to follow-up
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.1
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Reporting groups
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Reporting group title |
Aripiprazole Once-monthly
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Reporting group description |
Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline | ||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
