Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A trial to study effects of a single dose Citalopram on emotion processing in female patients with Borderline Personality Disorder and the associated modulation of fMRI BOLD signals

    Summary
    EudraCT number
    		 2018-001212-30
    Trial protocol
    		 DE  
    Global end of trial date
    22 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Oct 2021
    First version publication date
    27 Oct 2021
    Other versions
    Summary report(s)
    		 Original publication
    Online supplement

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ECEP-BPD
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Central Institute of Mental Health
    Sponsor organisation address
    J5, Mannheim, Germany, D-68159
    Public contact
    Department PSM, Central Institute of Mental Health, +49 62117034002, Christian.schmahl@zi-mannheim.de
    Scientific contact
    Department PSM, Central Institute of Mental Health, +49 62117034002, Christian.schmahl@zi-mannheim.de
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Jun 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Oct 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Oct 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effects of a single dose of Citalopram (20 mg) compared to placebo on BOLD responses on the amygdala and related brain structures induced by emotional stimuli using functional Magnetic Resonance Imaging (fMRI) in un-medicated female participants with Borderline Personality Disorder.
    Protection of trial subjects
    Vital signs: Vital signs (pulse rate, systolic and diastolic blood pressure and body temperature) determined on predefined study days were documented as numerical values on appropriate CRF-pages. Furthermore, vital signs were recorded at any time, if medically imperative for clarification of clinical signs and symptoms. 12-lead ECG: Only pathological and clinically relevant findings in 12-lead ECG determined on predefined study days were documented on appropriate CRF-pages. 12-lead ECG could be recorded at any time at discretion of the responsible investigator, if medically imperative for clarification of clinical signs and symptoms. Clinical chemistry, hematology and clotting: Following parameters were determined on the predefined study days: Clinical chemistry: sodium, potassium, calcium, magnesium, total protein, albumin, glucose, creatinine, urea, bilirubin, ASAT, ALAT, GGT, LDH, AP, CRP. Hematology: leukocytes, granulocytes, neutrophils, eosinophils, basophiles, lymphocytes, monocytes, erythrocytes, thrombocytes, haematocrit, haemoglobin. Clotting: aPTT, INR. After collection, the samples were immediately be delivered to the laboratory for respective determinations. All parameters were documented on appropriate CRF-pages. Further laboratory parameters could be determined at any time during the study at discretion of the responsible investigator.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Oct 2018
    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
    Germany: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    30
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Patients were recruited from the in- and out-patient units of the Department of Psychosomatic Medicine and Psychotherapy.

    Pre-assignment
    Screening details
    		 Assessed for eligibility: n=209 Excluded: n=179 not meeting inclusion criteria: n=111 not interested to participate: n=32 expressed interest at first call, but were not anymore reached: n=29 other reasons: n=7

    Period 1
    Period 1 title
    Allocation to sequence (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Assessor
    Blinding implementation details
    In addition to the trial medication the investigator received a set of sealed envelopes, one for each randomisation number. An identical set of sealed envelopes was held at pharmacovigilance. These envelopes contained information on the subject’s trial medication and were to be opened only under circumstances in which it is medically imperative to know what the subject is receiving. The randomisation envelopes were not to be opened.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sequence Citalopram-Placebo
    Arm description
    		 Patients received Citalopram in the first visit and Placebo in the second visit, after 1 week washout. After substance intake and a waiting period of 3h, participants were asked to report current mood with the Positive and Negative Affect Schedule (PANAS). Afterwards, they participated in the fMRI experiment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Citalopram hybrobromid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    The subject was administered the study medication orally (20 mg of Citalopram).

    Investigational medicinal product name
    DAC filler (99.5 % mannitol und 0.5 % highly dispersed silicon dioxide)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    The subject was administered the study medication orally

    Arm title
    		 Sequence Placebo-Citalopram
    Arm description
    		 Patients in this arm received placebo first and after the 1-week washout, received Citalopram. After substance intake and a waiting period of 3h, participants were asked to report current mood with the Positive and Negative Affect Schedule (PANAS). Afterwards, they participated in the fMRI experiment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Citalopram hybrobromid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg administered orally

    Investigational medicinal product name
    DAC filler (99.5 % mannitol und 0.5 % highly dispersed silicon dioxide)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    administered orally

    Number of subjects in period 1
    		Sequence Citalopram-Placebo Sequence Placebo-Citalopram
    Started
    15
    15
    Received treatment
    14
    14
    Completed
    14
    14
    Not completed
    1
    1
         Lost to follow-up
    1
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Sequence Citalopram-Placebo
    Reporting group description
    		 Patients received Citalopram in the first visit and Placebo in the second visit, after 1 week washout. After substance intake and a waiting period of 3h, participants were asked to report current mood with the Positive and Negative Affect Schedule (PANAS). Afterwards, they participated in the fMRI experiment.

    Reporting group title
    Sequence Placebo-Citalopram
    Reporting group description
    		 Patients in this arm received placebo first and after the 1-week washout, received Citalopram. After substance intake and a waiting period of 3h, participants were asked to report current mood with the Positive and Negative Affect Schedule (PANAS). Afterwards, they participated in the fMRI experiment.

    Reporting group values
    		 Sequence Citalopram-Placebo Sequence Placebo-Citalopram Total
    Number of subjects
    		 15 15 30
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 28.53 ± 7.74 33.40 ± 7.28 -
    Gender categorical
    Only female participants were included.
    Units: Subjects
        Female
    		 15 15 30
        Male
    		 0 0 0
    Comorbid DSM-5 Disorders
    Units: Subjects
        Major Depression
    		 0 0 0
        Dysthymia
    		 0 0 0
        Double Depression
    		 0 0 0
        Panic disorder
    		 0 0 0
        Social phobia
    		 0 0 0
        Specific phobia
    		 0 0 0
        Posttraumatic Stress Disorder
    		 0 0 0
        Anorexia nervosa
    		 0 0 0
        Bulimia nervosa
    		 0 0 0
        Binge-eating disorder
    		 0 0 0
        other
    		 15 15 30
    BPD DSM-5 criteria
    Number of DSM-5 BPD criteria
    Units: points
        arithmetic mean (standard deviation)
    		 5.53 ± 0.83 5.87 ± 0.92 -
    MADRS
    Units: points
        arithmetic mean (standard deviation)
    		 15.47 ± 7.99 14.53 ± 6.70 -
    ZAN-BPD
    Interview version of Zanarini rating scale
    Units: points
        arithmetic mean (standard deviation)
    		 10.40 ± 4.52 12.47 ± 3.50 -
    BDI
    Beck Depression Inventory
    Units: points
        arithmetic mean (standard deviation)
    		 21.20 ± 8.65 24.33 ± 11.65 -
    BAI
    Beck Anxiety Inventory
    Units: points
        arithmetic mean (standard deviation)
    		 20.53 ± 8.88 15.47 ± 8.84 -
    BSL-23
    Borderline Symptom List short version
    Units: points
        arithmetic mean (standard deviation)
    		 33.53 ± 15.45 34.33 ± 18.96 -
    Subject analysis sets

    Subject analysis set title
    Citalopram treatment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is a within-subject trial; all subjects received Citalopram and Placebo treatment in a crossover design.

    Subject analysis set title
    Placebo treatment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is a withinsubject crossover design: all subjects received Citalopram and Placebo treatment

    Subject analysis sets values
    		 Citalopram treatment Placebo treatment
    Number of subjects
    15
    15
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ±
    ±
    Gender categorical
    Only female participants were included.
    Units: Subjects
        Female
        Male
    Comorbid DSM-5 Disorders
    Units: Subjects
        Major Depression
        Dysthymia
        Double Depression
        Panic disorder
        Social phobia
        Specific phobia
        Posttraumatic Stress Disorder
        Anorexia nervosa
        Bulimia nervosa
        Binge-eating disorder
        other
    15
    15
    BPD DSM-5 criteria
    Number of DSM-5 BPD criteria
    Units: points
        arithmetic mean (standard deviation)
    ±
    ±
    MADRS
    Units: points
        arithmetic mean (standard deviation)
    ±
    ±
    ZAN-BPD
    Interview version of Zanarini rating scale
    Units: points
        arithmetic mean (standard deviation)
    ±
    ±
    BDI
    Beck Depression Inventory
    Units: points
        arithmetic mean (standard deviation)
    ±
    ±
    BAI
    Beck Anxiety Inventory
    Units: points
        arithmetic mean (standard deviation)
    ±
    ±
    BSL-23
    Borderline Symptom List short version
    Units: points
        arithmetic mean (standard deviation)
    ±
    ±

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Sequence Citalopram-Placebo
    Reporting group description
    		 Patients received Citalopram in the first visit and Placebo in the second visit, after 1 week washout. After substance intake and a waiting period of 3h, participants were asked to report current mood with the Positive and Negative Affect Schedule (PANAS). Afterwards, they participated in the fMRI experiment.

    Reporting group title
    Sequence Placebo-Citalopram
    Reporting group description
    		 Patients in this arm received placebo first and after the 1-week washout, received Citalopram. After substance intake and a waiting period of 3h, participants were asked to report current mood with the Positive and Negative Affect Schedule (PANAS). Afterwards, they participated in the fMRI experiment.

    Subject analysis set title
    Citalopram treatment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is a within-subject trial; all subjects received Citalopram and Placebo treatment in a crossover design.

    Subject analysis set title
    Placebo treatment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This is a withinsubject crossover design: all subjects received Citalopram and Placebo treatment

    Primary: Left amygdala BOLD response to negative scenes

    		 Close Top of page
    End point title
    		 Left amygdala BOLD response to negative scenes
    End point description
    We presented 42 pictures from the OASIS picture set (39) to induce negative affect. We used pictures with negative affective valence and high arousal (AC) in a block-design. During each of 14 blocks, lasting 18 seconds, three picture stimuli were presented for 6 seconds each, resulting in a set of 42 negative pictures in total. Due to the within-subject design, we used two picture sets with similar characteristics concerning affective valence and arousal to avoid habituation to picture content. These two sets were randomized between treatment visits to avoid undesired effects of systematic presentation order. Scrambled pictures were used in a non-affective control condition (NC) with the same number of trials and presentation time. During the intertrial interval (jittered to nine, 10, or 11 seconds), participants viewed a white fixation cross on a black background.
    End point type
    Primary
    End point timeframe
    3 hrs after substance intake
    End point values
    		 Citalopram treatment Placebo treatment
    Number of subjects analysed
    23
    23
    Units: %BOLD signal change
        arithmetic mean (standard deviation)
    0.166 ± 0.1002
    0.1604 ± 0.1423
    Statistical analysis title
    		 Region-of-interest anlysis
    Statistical analysis description
    Regions-of-interest (ROIs) were localized by intersecting the AC>NC (faces-task and scenes-task) activation maps derived from a 15-participant prestudy (unpublished data) with substructures of the Harvard-Oxford atlas (HOA) implemented in FSL (41). The statistical maps were thresholded at z > 2.3, while the atlas regions were thresholded at 50% probability.
    Comparison groups
    Placebo treatment v Citalopram treatment
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.05 [2]
    Method
    		 Permutation test
    Parameter type
    		 Mean difference (final values)
    Confidence interval
    Notes
    [1] - For the hypothesis-test, we used the mean percent signal change of all voxels within each ROI. We did not correct for multiple comparisons where we had a-priori hypotheses about treatment effects. First-level GLM results were converted into %BOLD signal change values and initially characterised at the group level as the 90th percentile value per participant within pre-specified ROIs.
    [2] - To test for the effect of Citalopram versus Placebo we derived p-values based on permutation analyses.

    Primary: Right amygdala BOLD response to negative scenes

    		 Close Top of page
    End point title
    		 Right amygdala BOLD response to negative scenes
    End point description
    End point type
    Primary
    End point timeframe
    3 hrs after substance intake
    End point values
    		 Citalopram treatment Placebo treatment
    Number of subjects analysed
    23
    23
    Units: %BOLD signal change
        arithmetic mean (standard deviation)
    0.1673 ± 0.1019
    0.1797 ± 0.1356
    Statistical analysis title
    		 Region-of-interest analysis
    Comparison groups
    Placebo treatment v Citalopram treatment
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Left amygdala BOLD response to faces

    		 Close Top of page
    End point title
    		 Left amygdala BOLD response to faces
    End point description
    Participants viewed faces with emotional expression (disgust, sadness, and fear were chosen based on meta-analyses) from the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP, http://www.emotional-face.org/). A block design of 12 blocks with 6 faces each (aversive condition, AC; negative emotional expressions were randomly mixed within blocks) and 12 blocks with scrambled faces (neutral condition, NC) was used. Scrambled faces were chosen as control because of two reasons: First, we wanted to match the faces task with the scenes task in terms of the analyzed contrast. Second, previous work suggested altered responding in BPD not only to emotional expressions but also to faces with neutral expression (37), which would compromise the sensitivity of our design to detect drug-induced changes. In sum, 72 negative faces of 24 actors (12 female, 12 male) were shown for 3 seconds each.
    End point type
    Secondary
    End point timeframe
    3 hrs after substance intake
    End point values
    		 Citalopram treatment Placebo treatment
    Number of subjects analysed
    25
    25
    Units: %BOLD signal change
        arithmetic mean (standard deviation)
    0.1601 ± 0.1148
    0.2342 ± 0.1543
    Statistical analysis title
    		 Region-of-interest analysis
    Statistical analysis description
    see primary outcome
    Comparison groups
    Placebo treatment v Citalopram treatment
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Right amygdala BOLD response to faces

    		 Close Top of page
    End point title
    		 Right amygdala BOLD response to faces
    End point description
    see primary outcome
    End point type
    Secondary
    End point timeframe
    3 hrs after substance intake
    End point values
    		 Citalopram treatment Placebo treatment
    Number of subjects analysed
    25
    25
    Units: %BOLD signal change
        arithmetic mean (standard deviation)
    0.1881 ± 0.1171
    0.2564 ± 0.1369
    Statistical analysis title
    		 Region-of-interest analysis
    Statistical analysis description
    see primary outcomes
    Comparison groups
    Placebo treatment v Citalopram treatment
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From first to last visit
    Adverse event reporting additional description
    A detailed description of AEs is given in the open access online-supplement to the original publication of this trial and can be downloaded via this link: https://doi.org/10.1016/j.bpsc.2021.02.002.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    N/A
    Reporting groups
    Reporting group title
    Full sample, Citalopram treatment
    Reporting group description
    		 -

    Reporting group title
    Full sample, Placebo treatment
    Reporting group description
    		 -

    Serious adverse events
    		 Full sample, Citalopram treatment Full sample, Placebo treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Full sample, Citalopram treatment Full sample, Placebo treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 29 (48.28%)
    8 / 29 (27.59%)
    General disorders and administration site conditions
    Headache
         subjects affected / exposed
    5 / 29 (17.24%)
    6 / 29 (20.69%)
         occurrences all number
    5
    6
    Sleep disorder
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    Thirst
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    Stress symptoms
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Tinnitus
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    Attention impaired
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Depressed mood
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Vertigo
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    Tiredness
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    Restlessness
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    Dizziness
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Mucus nasal increased
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Pain behind eyes
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    Psychiatric disorders
    Delusional disorder, paranoid type
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    Dissociative disorder
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 29 (3.45%)
         occurrences all number
    1
    1
    Endocrine disorders
    Sweating increased
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    Musculoskeletal and connective tissue disorders
    Tightness of jaw muscles
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    Muskoloskeletal chest pain
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Muscle pain
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Neck stiffness
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    Tremor
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0

    More information

    		 Close Top of page

    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.
    Interested readers are referred to the original publication of this trial: https://doi.org/10.1016/j.bpsc.2021.02.002 (see also summary text files) provided with CC BY license (http://creativecommons.org/licenses/by/4.0/).

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/33607327
    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.

    European Medicines Agency © 1995-Fri Apr 26 10:18:48 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA