Trial · NCT02006628

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

NCT02006628, Phase 2, Completed, Jazz Pharmaceuticals; results first posted 2019-07-26

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study of GWP42003 as Adjunctive Therapy in the First Line Treatment of Schizophrenia or Related Psychotic Disorder. Trials, record NCT02006628. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02006628

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of GWP42003 as Adjunctive Therapy in the First Line Treatment of Schizophrenia or Related Psychotic Disorder
NCT number: NCT02006628
Status: Completed
Phases: Phase 2
Enrollment: 88 participants, actual
Lead sponsor: Jazz Pharmaceuticals
Conditions: Schizophrenia, Schizophrenia-related Psychotic Disorder
Interventions: Placebo, GWP42003
First posted: 2013-12-10
Last updated: 2022-09-28
Other registries' IDs: eudract:2013-000212-22
Results first posted: 2019-07-26

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline To End Of Treatment (Day 43) In Positive And Negative Syndrome Scale (PANSS) Total Score	Day 1 through Day 43	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.
Primary	Percentage Of PANSS Total Score Responders At End Of Treatment (Day 43)	Day 1 through 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.
Primary	Change From Baseline To The End Of Treatment (Day 43) In PANSS 'P' Score	Day 1 through Day 43	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.
Primary	Change From Baseline To The End Of Treatment (Day 43) In PANSS 'N' Score	Day 1 through Day 43	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.
Primary	Change From Baseline To The End Of Treatment (Day 43) In PANSS 'G' Score	Day 1 through Day 43	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.
Primary	Change From Baseline To The End Of Treatment (Day 43) In The Scale For The Assessment Of Negative Symptoms (SANS)	Day 1 through Day 43	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.
Primary	Change From Baseline To The End Of Treatment (Day 43) In The Clinical Global Impression Severity Scale (CGI-S)	Day 1 through Day 43	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.
Primary	Clinical Global Impression Improvement Scale (CGI-I) Values At Day 8 And End Of Treatment (Day 43)	Day 8 through 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.
Primary	Change From Baseline To The End Of Treatment (Day 43) In Brief Assessment Of Cognition In Schizophrenia (BACS) Score	Day 1 through Day 43	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.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline To End Of Treatment (Day 43) In Positive And Negative Syndrome Scale (PANSS) Total Score	Day 1 through Day 43	ITT analysis set: all participants who provided informed consent, were randomized to 1 of the treatment groups, took at least 1 dose of IMP, and had post-baseline efficacy data. One placebo participant with a PANSS Total score \<60 at Day 1 and 1 GWP42003 participant with no post-baseline efficacy data were excluded from the ITT analysis set.	score on a scale	MEAN
PRIMARY	Percentage Of PANSS Total Score Responders At End Of Treatment (Day 43)	Day 1 through Day 43	ITT analysis set: all participants who provided informed consent, were randomized to 1 of the treatment groups, took at least 1 dose of IMP, and had post-baseline efficacy data. One placebo participant with a PANSS Total score \<60 at Day 1 and 1 GWP42003 participant with no post-baseline efficacy data were excluded from the ITT analysis set.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Change From Baseline To The End Of Treatment (Day 43) In PANSS 'P' Score	Day 1 through Day 43	ITT analysis set: all participants who provided informed consent, were randomized to 1 of the treatment groups, took at least 1 dose of IMP, and had post-baseline efficacy data. One placebo participant with a PANSS Total score \<60 at Day 1 and 1 GWP42003 participant with no post-baseline efficacy data were excluded from the ITT analysis set.	score on a scale	MEAN
PRIMARY	Change From Baseline To The End Of Treatment (Day 43) In PANSS 'N' Score	Day 1 through Day 43	ITT analysis set: all participants who provided informed consent, were randomized to 1 of the treatment groups, took at least 1 dose of IMP, and had post-baseline efficacy data. One placebo participant with a PANSS Total score \<60 at Day 1 and 1 GWP42003 participant with no post-baseline efficacy data were excluded from the ITT analysis set.	score on a scale	MEAN
PRIMARY	Change From Baseline To The End Of Treatment (Day 43) In PANSS 'G' Score	Day 1 through Day 43	ITT analysis set: all participants who provided informed consent, were randomized to 1 of the treatment groups, took at least 1 dose of IMP, and had post-baseline efficacy data. One placebo participant with a PANSS Total score \<60 at Day 1 and 1 GWP42003 participant with no post-baseline efficacy data were excluded from the ITT analysis set.	score on a scale	MEAN
PRIMARY	Change From Baseline To The End Of Treatment (Day 43) In The Scale For The Assessment Of Negative Symptoms (SANS)	Day 1 through Day 43	ITT analysis set: all participants who provided informed consent, were randomized to 1 of the treatment groups, took at least 1 dose of IMP, and had post-baseline efficacy data. One placebo participant with a PANSS Total score \<60 at Day 1 and 1 GWP42003 participant with no post-baseline efficacy data were excluded from the ITT analysis set.	score on a scale	MEAN
PRIMARY	Change From Baseline To The End Of Treatment (Day 43) In The Clinical Global Impression Severity Scale (CGI-S)	Day 1 through Day 43	ITT analysis set: all participants who provided informed consent, were randomized to 1 of the treatment groups, took at least 1 dose of IMP, and had post-baseline efficacy data. One placebo participant with a PANSS Total score \<60 at Day 1 and 1 GWP42003 participant with no post-baseline efficacy data were excluded from the ITT analysis set.	score on a scale	MEAN
PRIMARY	Clinical Global Impression Improvement Scale (CGI-I) Values At Day 8 And End Of Treatment (Day 43)	Day 8 through Day 43	ITT analysis set: all participants who provided informed consent, were randomized to 1 of the treatment groups, took at least 1 dose of IMP, and had post-baseline efficacy data. One placebo participant with a PANSS Total score \<60 at Day 1 and 1 GWP42003 participant with no post-baseline efficacy data were excluded from the ITT analysis set.	score on a scale	MEAN
PRIMARY	Change From Baseline To The End Of Treatment (Day 43) In Brief Assessment Of Cognition In Schizophrenia (BACS) Score	Day 1 through Day 43	ITT analysis set: all participants who provided informed consent, were randomized to 1 of the treatment groups, took at least 1 dose of IMP, and had post-baseline efficacy data. One placebo participant with a PANSS Total score \<60 at Day 1 and 1 GWP42003 participant with no post-baseline efficacy data were excluded from the ITT analysis set.	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group50

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline To End Of Treatment (Day 43) In Positive And Negative Syndrome Scale (PANSS) Total Score	GWP42003 1000 mg/Day	Baseline score	79.3	Standard Deviation 12.45	score on a scale
Change From Baseline To End Of Treatment (Day 43) In Positive And Negative Syndrome Scale (PANSS) Total Score	Placebo	Baseline score	80.6	Standard Deviation 14.90	score on a scale
Change From Baseline To End Of Treatment (Day 43) In Positive And Negative Syndrome Scale (PANSS) Total Score	GWP42003 1000 mg/Day	End of Treatment score	68.1	Standard Deviation 14.79	score on a scale
Change From Baseline To End Of Treatment (Day 43) In Positive And Negative Syndrome Scale (PANSS) Total Score	Placebo	End of Treatment score	71.9	Standard Deviation 15.49	score on a scale
Change From Baseline To End Of Treatment (Day 43) In Positive And Negative Syndrome Scale (PANSS) Total Score	GWP42003 1000 mg/Day	Change from baseline	-11.2	Standard Deviation 7.87	score on a scale
Change From Baseline To End Of Treatment (Day 43) In Positive And Negative Syndrome Scale (PANSS) Total Score	Placebo	Change from baseline	-8.8	Standard Deviation 8.87	score on a scale
Percentage Of PANSS Total Score Responders At End Of Treatment (Day 43)	GWP42003 1000 mg/Day	Yes	12		Participants
Percentage Of PANSS Total Score Responders At End Of Treatment (Day 43)	Placebo	Yes	6		Participants
Percentage Of PANSS Total Score Responders At End Of Treatment (Day 43)	GWP42003 1000 mg/Day	No	30		Participants
Percentage Of PANSS Total Score Responders At End Of Treatment (Day 43)	Placebo	No	38		Participants

1 to 10 of 50Source ClinicalTrials.gov

See all 50 results by group

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	GWP42003 1000 Milligram (mg)/Day	43
Overall Study	STARTED	Placebo	45
Overall Study	Received at Least 1 Dose of Study Drug	GWP42003 1000 Milligram (mg)/Day	43
Overall Study	Received at Least 1 Dose of Study Drug	Placebo	45
Overall Study	Intention to Treat (ITT) Analysis Set	GWP42003 1000 Milligram (mg)/Day	42
Overall Study	Intention to Treat (ITT) Analysis Set	Placebo	44
Overall Study	COMPLETED	GWP42003 1000 Milligram (mg)/Day	40
Overall Study	COMPLETED	Placebo	43
Overall Study	NOT COMPLETED	GWP42003 1000 Milligram (mg)/Day	3
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhoea	Gastrointestinal disorders	GWP42003 1000 mg/Day	4	43
other	Diarrhoea	Gastrointestinal disorders	Placebo	2	45
other	Nausea	Gastrointestinal disorders	GWP42003 1000 mg/Day	3	43
other	Nausea	Gastrointestinal disorders	Placebo	0	45
other	Headache	Nervous system disorders	GWP42003 1000 mg/Day	3	43
other	Headache	Nervous system disorders	Placebo	4	45
other	Somnolence	Nervous system disorders	GWP42003 1000 mg/Day	0	43
other	Somnolence	Nervous system disorders	Placebo	3	45
other	Insomnia	Psychiatric disorders	GWP42003 1000 mg/Day	0	43
other	Insomnia	Psychiatric disorders	Placebo	2	45

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	GWP42003 1000 mg/Day
Total, all-cause mortality	Placebo
Total, other adverse events	GWP42003 1000 mg/Day	8	43
Total, other adverse events	Placebo	10	45
Total, serious adverse events	GWP42003 1000 mg/Day	0	43
Total, serious adverse events	Placebo	1	45

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29241357	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
GWP42003 1000 mg/Day vs Placebo: serious adverse events

Source Trial comparisons

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Verbal Fluency	Primary outcome

Source ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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