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CompletedNCT02006628Updated Sep 28, 2022Results posted

A Study of GWP42003 as Adjunctive Therapy in the First Line Treatment of Schizophrenia or Related Psychotic Disorder

A Phase 2 interventional study of Placebo and GWP42003 in Schizophrenia and Schizophrenia-related Psychotic Disorder, sponsored by Jazz Pharmaceuticals. Completed at 15 sites in 3 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-09-28.

Sponsored by Jazz Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

A study to compare the change in symptom severity in participants with schizophrenia or related psychotic disorder when treated with GWP42003 or placebo in conjunction with existing anti-psychotic therapy over a period of six weeks.

Read the detailed description

This eight-week (six-week treatment period and two-week follow-up), multi-centre, double-blind, randomized, placebo-controlled, parallel group study aimed to determine the efficacy, safety and tolerability of GWP42003 in participants with schizophrenia or a related psychotic disorder.

Eligible participants entered the study at a Screening and Randomization Visit (Day 1), where eligibility was established. Once all inclusion and exclusion criteria were reviewed, participants were randomized to receive either GWP42003 or placebo in conjunction with their prescribed anti-psychotic medications and began treatment on Day 1 as instructed. Assessments were performed on Days 8, 22, and 43. A safety follow-up visit was conducted on Day 57.

02

Conditions studied

  • Schizophrenia
  • Schizophrenia-related Psychotic Disorder

Keywords

  • GWP42003
  • Cannabinoids
  • Schizophrenia
  • CBD
  • Cannabidiol
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 88 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Jazz Pharmaceuticals is the lead sponsor of 167 studies on the registry; 20 are open to participants now.

Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participant gave written informed consent for participation in the study and did not require involuntary treatment.
  • Participant was male or female aged 18 to 65 years.
  • Participant was able (in the investigator's opinion) and willing to comply with all study requirements.
  • Participant was diagnosed with schizophrenia or a related psychotic disorder (such as schizoaffective or schizophreniform disorder) as defined by the Diagnostic and Statistical Manual of Mental Disorders Version 4.
  • Participant was treated for a minimum of four-weeks and was on a stable dose of his or her current anti-psychotic (AP) medication.
  • Participant showed the capacity to respond at least partially to first line AP medication in the opinion of the investigator.
  • Participant remained stable on his or her dose of AP and concomitant medications for the duration of the study, in the opinion of the investigator.
  • Participant was willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable in individual countries.
  • Participant was willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study.

Exclusion criteria

Exclusion Criteria (any of the following):

  • Participant had any known or suspected hypersensitivity to cannabinoids or any of the excipients of the Investigational Medicinal Product (IMP).
  • Participant had a Positive and Negative Symptom Scale total score of \<60 at Day 1.

  • Participant presented with a current clinical picture and/or history that is consistent with:

    i. delirium or dementia. ii. acute drug induced psychosis. iii. bipolar disorder.

  • Participant was taking more the one AP medication during the study.
  • Female participants of child bearing potential and male participants whose partner was of child bearing potential, unless willing to ensure that they or their partner used effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for three months thereafter (a male condom was not used in conjunction with a female condom).
  • Female participant who was pregnant, lactating, or planning pregnancy during the course of the study and for three months thereafter.
  • Participants who had received an IMP within 30 days prior to the screening visit.
  • Participants who had any other significant disease or disorder which, in the opinion of the investigator, either put the participant at risk because of participation in the study, or may have influenced the result of the study, or the participant's ability to participate in the study.
  • Participant had any abnormalities following a physical examination that, in the opinion of the investigator, prevented the participant from safe participation in the study.
  • Participant was unwilling to abstain from donation of blood during the study.
  • Participant had travelled outside the country of residence during the study.
  • Participant previously randomized into this study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
88 participants (actual)

Study arms

  • Active comparator
    GWP42003 1000 milligrams (mg)/day

    Participants received GWP42003 (100 mg/milliliter \[mL\]), 5 mL twice daily (BID) administered orally, 5 mL in the morning and 5 mL in the evening for 6 weeks.

    Drug: GWP42003

  • Placebo comparator
    Placebo

    Participants received placebo (0 mL cannabidiol \[CBD\]), volume matched to the 5 mL BID dose level, administered orally, 5 mL in the morning and 5 mL in the evening for 6 weeks.

    Drug: Placebo

Interventions

  • DrugPlacebo

    Placebo oral solution (0 milligrams \[mg\]/mL CBD) contained the excipients sesame oil, ethanol, sucralose, and strawberry flavoring.

    Also known as: Placebo control

  • DrugGWP42003

    GWP42003 was an oral solution containing 100 mg/mL CBD dissolved in the excipients sesame oil, ethanol, sucralose and strawberry flavoring.

    Also known as: Cannabidiol

06

What researchers measure

Primary outcomes

  1. Change From Baseline To End Of Treatment (Day 43) In Positive And Negative Syndrome Scale (PANSS) Total Score

    The PANSS was a 30-item medical scale completed by a trained rater that assessed the positive and negative symptoms of schizophrenia as well as symptoms of general psychopathology. The PANSS Total score was derived from the sum of the 30 items, which were rated on a 7-point scale, where 1 = absent and 7 = extreme. The total score is the summed total for each of the PANSS positive symptom ('P'), negative symptom ('N'), general psychopathology symptom ('G') scores and could range from 30 to 210 points, with lower scores equating to milder severity of symptoms, that is, closer to psychologically normal.

    Time frame: Day 1 through Day 43

  2. Percentage Of PANSS Total Score Responders At End Of Treatment (Day 43)

    The percentage of PANSS treatment responders, defined as participants with ≥20% improvement in PANSS Total score between baseline and End of Treatment, is presented. The percentage of participants was calculated by dividing the number of participants with a ≥20% improvement in PANSS Total score (yes) by the total number of participants.

    Time frame: Day 1 through Day 43

  3. Change From Baseline To The End Of Treatment (Day 43) In PANSS 'P' Score

    The PANSS 'P' scale measured the severity of positive symptoms, including delusions, conceptual disorganization, hallucinations, hyperactivity, grandiosity, suspiciousness/persecution, and hostility. Individual items were rated on a 7-point scale, where 1 = absent and 7 = extreme. The total 'P' score could range from 7 to 49 points, with lower scores equating to milder severity of symptoms, that is, closer to psychologically normal.

    Time frame: Day 1 through Day 43

  4. Change From Baseline To The End Of Treatment (Day 43) In PANSS 'N' Score

    The PANSS 'N' scale measured the severity of negative symptoms, including blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Individual items were rated on a 7-point scale, where 1 = absent and 7 = extreme. The total 'N' score could range from 7 to 49 points, with lower scores equating to milder severity of symptoms, that is, closer to psychologically normal.

    Time frame: Day 1 through Day 43

  5. Change From Baseline To The End Of Treatment (Day 43) In PANSS 'G' Score

    The PANSS 'G' scale measured the severity of general psychopathology symptoms, including somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgement and insight, disturbance of violation, poor impulse control, preoccupation, and active social avoidance. Individual items were rated on a 7-point scale, where 1 = absent and 7 = extreme. The total 'G' score could range from 16 to 112 points, with lower scores equating to milder severity of symptoms, that is, closer to psychologically normal.

    Time frame: Day 1 through Day 43

  6. Change From Baseline To The End Of Treatment (Day 43) In The Scale For The Assessment Of Negative Symptoms (SANS)

    The SANS assessed 5 symptom complexes to obtain clinical ratings of negative symptoms in participants with schizophrenia or related psychotic disorder. Symptom complexes were affective blunting, alogia (impoverished thinking), avolition/apathy, anhedonia/asociality, and disturbance of attention. Assessments were conducted on a 6-point scale (0 = not at all; 5 = severe). The total score could range from 0 to 125 points, with lower scores equating to milder severity of symptoms, that is, closer to psychologically normal.

    Time frame: Day 1 through Day 43

  7. Change From Baseline To The End Of Treatment (Day 43) In The Clinical Global Impression Severity Scale (CGI-S)

    The CGI-S was a 7-point scale that required the clinician to rate the severity of a participant's illness at the time of assessment, relative to the clinician's past experience of participants who had the same diagnosis. Considering total clinical experience, participants were assessed on severity of mental illness at the time of rating on the following scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; or 7 = extremely ill. Lower scores equated to milder severity of symptoms, that is, closer to psychologically normal.

    Time frame: Day 1 through Day 43

  8. Clinical Global Impression Improvement Scale (CGI-I) Values At Day 8 And End Of Treatment (Day 43)

    The CGI-I was a 7-point scale that required the clinician to assess how much a participant's illness had improved or worsened relative the first assessment at the beginning of the intervention. This was rated on the following scale: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; or 7 = very much worse. Lower scores equated to improvement of symptoms.

    Time frame: Day 8 through Day 43

  9. Change From Baseline To The End Of Treatment (Day 43) In Brief Assessment Of Cognition In Schizophrenia (BACS) Score

    The BACS was an instrument used to assess the aspects of cognition found to be most impaired and most strongly correlated with outcome in participants with schizophrenia or related psychotic disorder. The BACS consisted of 6 domains: verbal memory (score range 0 to 75), working memory (score range 0 to 28), motor speed (score range 0 to 100), verbal fluency (score \> 0, with no set maximum value), attention and speed of information processing (score range 0 to 110), and executive functions (score range 0 to 22). A score was obtained for each of the 6 domains. A composite summary score was then calculated as the arithmetic mean of the unweighted scores from the 6 domains. While there was not an upper limit on the composite score, overall, an increase in score was indicative of an improvement in cognition.

    Time frame: Day 1 through Day 43

07

Results

Posted Jul 26, 2019

Participant flow

Participant flow — Overall Study
MilestoneGWP42003 1000 Milligram (mg)/DayPlacebo
Started4345
Received at least 1 dose of study drug4345
Intention to treat (itt) analysis set4244
Completed4043
Not completed32
Withdrew: Adverse event11
Withdrew: Withdrawal by subject21

Outcome measures

PrimaryChange From Baseline To End Of Treatment (Day 43) In Positive And Negative Syndrome Scale (PANSS) Total Score

The PANSS was a 30-item medical scale completed by a trained rater that assessed the positive and negative symptoms of schizophrenia as well as symptoms of general psychopathology. The PANSS Total score was derived from the sum of the 30 items, which were rated on a 7-point scale, where 1 = absent and 7 = extreme. The total score is the summed total for each of the PANSS positive symptom ('P'), negative symptom ('N'), general psychopathology symptom ('G') scores and could range from 30 to 210 points, with lower scores equating to milder severity of symptoms, that is, closer to psychologically normal.

Time frame:
Day 1 through Day 43
Reported as:
Mean · score on a scale
Change From Baseline To End Of Treatment (Day 43) In Positive And Negative Syndrome Scale (PANSS) Total Score
score on a scaleGWP42003 1000 mg/DayPlacebo
Baseline score79.3 ± 12.4580.6 ± 14.90
End of Treatment score68.1 ± 14.7971.9 ± 15.49
Change from baseline-11.2 ± 7.87-8.8 ± 8.87
Statistical analysis
  • GWP42003 1000 mg/Day vs Placebo · ANCOVA · p = 0.1332 · Treatment difference (gwp42003-placebo): -2.8 · 95% CI -6.5 to 0.9Change from baseline as the response variable, treatment as fixed effect, and individual baseline subscore and age as covariates.
PrimaryPercentage Of PANSS Total Score Responders At End Of Treatment (Day 43)

The percentage of PANSS treatment responders, defined as participants with ≥20% improvement in PANSS Total score between baseline and End of Treatment, is presented. The percentage of participants was calculated by dividing the number of participants with a ≥20% improvement in PANSS Total score (yes) by the total number of participants.

Time frame:
Day 1 through Day 43
Reported as:
Count of participants · Participants
Percentage Of PANSS Total Score Responders At End Of Treatment (Day 43)
ParticipantsGWP42003 1000 mg/DayPlacebo
Yes126
No3038
Statistical analysis
  • GWP42003 1000 mg/Day vs Placebo · Regression, Logistic · p = 0.0896 · Odds ratio (or): 2.62 · 95% CI 0.86 to 8.00Responder (yes/no) is the dependent variable with treatment included as factor and age and baseline P, G, and N scores included as covariates.
PrimaryChange From Baseline To The End Of Treatment (Day 43) In PANSS 'P' Score

The PANSS 'P' scale measured the severity of positive symptoms, including delusions, conceptual disorganization, hallucinations, hyperactivity, grandiosity, suspiciousness/persecution, and hostility. Individual items were rated on a 7-point scale, where 1 = absent and 7 = extreme. The total 'P' score could range from 7 to 49 points, with lower scores equating to milder severity of symptoms, that is, closer to psychologically normal.

Time frame:
Day 1 through Day 43
Reported as:
Mean · score on a scale
Change From Baseline To The End Of Treatment (Day 43) In PANSS 'P' Score
score on a scaleGWP42003 1000 mg/DayPlacebo
Baseline score18.0 ± 3.8917.5 ± 3.29
End of Treatment score14.8 ± 4.0115.7 ± 3.73
Change from Baseline-3.2 ± 2.60-1.7 ± 2.76
Statistical analysis
  • GWP42003 1000 mg/Day vs Placebo · ANCOVA · p = 0.0188 · Treatment difference (gwp42003-placebo): -1.4 · 95% CI -2.5 to -0.2
PrimaryChange From Baseline To The End Of Treatment (Day 43) In PANSS 'N' Score

The PANSS 'N' scale measured the severity of negative symptoms, including blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Individual items were rated on a 7-point scale, where 1 = absent and 7 = extreme. The total 'N' score could range from 7 to 49 points, with lower scores equating to milder severity of symptoms, that is, closer to psychologically normal.

Time frame:
Day 1 through Day 43
Reported as:
Mean · score on a scale
Change From Baseline To The End Of Treatment (Day 43) In PANSS 'N' Score
score on a scaleGWP42003 1000 mg/DayPlacebo
Baseline score22.6 ± 5.0423.4 ± 5.11
End of Treatment score19.9 ± 5.3220.5 ± 5.22
Change from Baseline-2.7 ± 3.55-2.9 ± 3.06
Statistical analysis
  • GWP42003 1000 mg/Day vs Placebo · ANCOVA · p = 0.9647 · Treatment difference (gwp42003-placebo): 0.0 · 95% CI -1.3 to 1.4
PrimaryChange From Baseline To The End Of Treatment (Day 43) In PANSS 'G' Score

The PANSS 'G' scale measured the severity of general psychopathology symptoms, including somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgement and insight, disturbance of violation, poor impulse control, preoccupation, and active social avoidance. Individual items were rated on a 7-point scale, where 1 = absent and 7 = extreme. The total 'G' score could range from 16 to 112 points, with lower scores equating to milder severity of symptoms, that is, closer to psychologically normal.

Time frame:
Day 1 through Day 43
Reported as:
Mean · score on a scale
Change From Baseline To The End Of Treatment (Day 43) In PANSS 'G' Score
score on a scaleGWP42003 1000 mg/DayPlacebo
Baseline score38.7 ± 6.7139.7 ± 8.95
End of Treatment score33.4 ± 7.6935.6 ± 9.04
Change from Baseline-5.3 ± 4.34-4.1 ± 4.78
Statistical analysis
  • GWP42003 1000 mg/Day vs Placebo · ANCOVA · p = 0.1963 · Treatment difference (gwp42003-placebo): -1.3 · 95% CI -3.2 to 0.7
PrimaryChange From Baseline To The End Of Treatment (Day 43) In The Scale For The Assessment Of Negative Symptoms (SANS)

The SANS assessed 5 symptom complexes to obtain clinical ratings of negative symptoms in participants with schizophrenia or related psychotic disorder. Symptom complexes were affective blunting, alogia (impoverished thinking), avolition/apathy, anhedonia/asociality, and disturbance of attention. Assessments were conducted on a 6-point scale (0 = not at all; 5 = severe). The total score could range from 0 to 125 points, with lower scores equating to milder severity of symptoms, that is, closer to psychologically normal.

Time frame:
Day 1 through Day 43
Reported as:
Mean · score on a scale
Change From Baseline To The End Of Treatment (Day 43) In The Scale For The Assessment Of Negative Symptoms (SANS)
score on a scaleGWP42003 1000 mg/DayPlacebo
Baseline score52.8 ± 17.1055.3 ± 16.24
End of Treatment score43.6 ± 16.5448.4 ± 15.75
Change from Baseline-9.1 ± 13.09-6.3 ± 8.54
Statistical analysis
  • GWP42003 1000 mg/Day vs Placebo · ANCOVA · p = 0.1167 · Treatment difference (gwp42003-placebo): -3.5 · 95% CI -7.9 to 0.9
PrimaryChange From Baseline To The End Of Treatment (Day 43) In The Clinical Global Impression Severity Scale (CGI-S)

The CGI-S was a 7-point scale that required the clinician to rate the severity of a participant's illness at the time of assessment, relative to the clinician's past experience of participants who had the same diagnosis. Considering total clinical experience, participants were assessed on severity of mental illness at the time of rating on the following scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; or 7 = extremely ill. Lower scores equated to milder severity of symptoms, that is, closer to psychologically normal.

Time frame:
Day 1 through Day 43
Reported as:
Mean · score on a scale
Change From Baseline To The End Of Treatment (Day 43) In The Clinical Global Impression Severity Scale (CGI-S)
score on a scaleGWP42003 1000 mg/DayPlacebo
Baseline score4.0 ± 0.704.0 ± 0.65
End of Treatment score3.5 ± 1.093.8 ± 0.78
Change from Baseline-0.5 ± 0.74-0.3 ± 0.49
Statistical analysis
  • GWP42003 1000 mg/Day vs Placebo · ANCOVA · p = 0.0443 · Treatment difference (gwp42003-placebo): -0.3 · 95% CI -0.5 to 0.0
PrimaryClinical Global Impression Improvement Scale (CGI-I) Values At Day 8 And End Of Treatment (Day 43)

The CGI-I was a 7-point scale that required the clinician to assess how much a participant's illness had improved or worsened relative the first assessment at the beginning of the intervention. This was rated on the following scale: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; or 7 = very much worse. Lower scores equated to improvement of symptoms.

Time frame:
Day 8 through Day 43
Reported as:
Mean · score on a scale
Clinical Global Impression Improvement Scale (CGI-I) Values At Day 8 And End Of Treatment (Day 43)
score on a scaleGWP42003 1000 mg/DayPlacebo
Day 8 score3.6 ± 0.503.8 ± 0.56
End of Treatment score2.9 ± 0.893.4 ± 0.87
Statistical analysis
  • GWP42003 1000 mg/Day vs Placebo · ANCOVA · p = 0.0182 · Treatment difference (gwp42003-placebo): -0.5 · 95% CI -0.8 to -0.1
PrimaryChange From Baseline To The End Of Treatment (Day 43) In Brief Assessment Of Cognition In Schizophrenia (BACS) Score

The BACS was an instrument used to assess the aspects of cognition found to be most impaired and most strongly correlated with outcome in participants with schizophrenia or related psychotic disorder. The BACS consisted of 6 domains: verbal memory (score range 0 to 75), working memory (score range 0 to 28), motor speed (score range 0 to 100), verbal fluency (score \> 0, with no set maximum value), attention and speed of information processing (score range 0 to 110), and executive functions (score range 0 to 22). A score was obtained for each of the 6 domains. A composite summary score was then calculated as the arithmetic mean of the unweighted scores from the 6 domains. While there was not an upper limit on the composite score, overall, an increase in score was indicative of an improvement in cognition.

Time frame:
Day 1 through Day 43
Reported as:
Mean · score on a scale
Change From Baseline To The End Of Treatment (Day 43) In Brief Assessment Of Cognition In Schizophrenia (BACS) Score
score on a scaleGWP42003 1000 mg/DayPlacebo
Baseline score32.21 ± 6.04232.91 ± 7.158
End of Treatment score35.73 ± 6.98135.05 ± 7.310
Change from Baseline3.48 ± 3.0312.14 ± 3.442
Statistical analysis
  • GWP42003 1000 mg/Day vs Placebo · ANCOVA · p = 0.0677 · Treatment difference (gwp42003-placebo): 1.31 · 95% CI -0.10 to 2.72

Adverse events

Collected over Day 1 through Day 57. Non-serious events are listed at a 4% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
GWP42003 1000 mg/Day—0/43 (0%)8/43 (18.6%)
Placebo—1/45 (2.2%)10/45 (22.2%)
Most frequent serious events
Most frequent serious events
EventGWP42003 1000 mg/DayPlacebo
SchizophreniaPsychiatric disorders0/431/45
Most frequent other events
Most frequent other events
EventGWP42003 1000 mg/DayPlacebo
DiarrhoeaGastrointestinal disorders4/432/45
HeadacheNervous system disorders3/434/45
NauseaGastrointestinal disorders3/430/45
SomnolenceNervous system disorders0/433/45
InsomniaPsychiatric disorders0/432/45

Baseline characteristics

Safety analysis set: Participants who provided informed consent, were randomized to 1 of the treatment groups, and took at least 1 dose of investigational medicinal product (IMP).

Age, Continuous
Age, Continuous(years)GWP42003 1000 mg/DayPlaceboTotal
Mean40.9 ± 12.4940.8 ± 11.0040.8 ± 11.69
Sex: Female, Male
Sex: Female, Male(Participants)GWP42003 1000 mg/DayPlaceboTotal
Female152237
Male282351
08

Study locations

15 sites
  • Czeladź, 41-250, Poland
  • Gdansk, 80-952, Poland
  • Kielce, 25-103, Poland
  • Lublin, 20-831, Poland
  • Tychy, 43-100, Poland
  • Wrocław, 54-235, Poland
  • Bucharest, 041914, Romania
  • Bucuresti, 010825, Romania
  • Bucuresti, 041914, Romania
  • Sibiu, 550082, Romania
  • Targoviste, 130086, Romania
  • Târgu-Mureş, 540096, Romania
  • Chertsey, KT16 0AE, United Kingdom
  • Coventry, CV2 2TE, United Kingdom
  • London, SE5 8AF, United Kingdom
09

References and documents

Publications

  • McGuire P, Robson P, Cubala WJ, Vasile D, Morrison PD, Barron R, Taylor A, Wright S. Cannabidiol (CBD) as an Adjunctive Therapy in Schizophrenia: A Multicenter Randomized Controlled Trial. Am J Psychiatry. 2018 Mar 1;175(3):225-231. doi: 10.1176/appi.ajp.2017.17030325. Epub 2017 Dec 15. PubMed 29241357 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02006628
Lead sponsor
Jazz Pharmaceuticals
Responsible party
Sponsor
First posted
Dec 10, 2013
Start date
Feb 25, 2014
Primary completion
Jan 8, 2015
Completion
Jan 8, 2015
Results posted
Jul 26, 2019
Last update
Sep 28, 2022

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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