SchizophreniaPhase 2NCT02006628
A Study of GWP42003 as Adjunctive Therapy in the First Line Treatment of Schizophrenia or Related Psychotic Disorder
A Phase 2 study testing GWP42003 in people with Schizophrenia and Schizophrenia-related Psychotic Disorder, run by Jazz Pharmaceuticals at 14 sites in 3 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizophrenia-related Psychotic Disorder
- What is being tested?
- GWP42003
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 14 sitesin 3 countries
- Study dates
- 25 Feb 2014to 8 Jan 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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:
- 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).
Show all 13Show fewer
- 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.
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
Poland6 sites
Study site
Czeladź, 41-250
Study site
Gdansk, 80-952
Study site
Kielce, 25-103
Study site
Lublin, 20-831
Study site
Tychy, 43-100
Study site
Wroclaw, 54-235
Romania5 sites
Study site
Bucharest, 010825
Study site
Bucharest, 041914
Study site
Sibiu, 550082
Study site
Targoviste, 130086
Study site
Târgu Mureş, 540096
United Kingdom3 sites
Study site
Chertsey, KT16 0AE
Study site
Coventry, CV2 2TE
Study site
London, SE5 8AF
About this study
Official title: A Double-blind, Randomised, Placebo-controlled, Parallel Group Study of GWP42003 as Adjunctive Therapy in the First Line Treatment of Schizophrenia or Related Psychotic Disorder
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.
- Being tested
- Placebo, GWP42003
- Keywords
- GWP42003, Cannabinoids, Schizophrenia, CBD, Cannabidiol
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Placebo control
Placebo oral solution (0 milligrams [mg]/mL CBD) contained the excipients sesame oil, ethanol, sucralose, and strawberry flavoring.
GWP42003Drug
Also called Cannabidiol
GWP42003 was an oral solution containing 100 mg/mL CBD dissolved in the excipients sesame oil, ethanol, sucralose and strawberry flavoring.
| Study group | Role | What they receive |
|---|---|---|
| GWP42003 1000 milligrams (mg)/day | Active comparator | 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. Receives: Drug: GWP42003 |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 through Day 43
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.
Measured: Day 1 through Day 43
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.
Measured: Day 1 through Day 43
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.
Measured: Day 1 through Day 43
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.
Measured: Day 1 through Day 43
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.
Measured: Day 1 through Day 43
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.
Measured: Day 1 through Day 43
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.
Measured: Day 8 through Day 43
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.
Measured: Day 1 through Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study start25 Feb 2014
- Primary completion8 Jan 2015
- Study completion8 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006628
- Sponsor's protocol ID
- GWAP1241
- Other IDs
- 2013-000212-22
- Status last verified
- Sep 2022
- First submitted
- 5 Dec 2013
- Last updated
- 28 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, Placebo-controlled, Parallel Group Study of GWP42003 as Adjunctive Therapy in the First Line Treatment of Schizophrenia or Related Psychotic Disorder
- ClinicalTrials.gov ID
- NCT02006628
- Acronym / sponsor ID
- GWAP1241
- Keywords
- GWP42003, Cannabinoids, Schizophrenia, CBD, Cannabidiol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2014 (actual)
- Primary completion
- 8 Jan 2015 (actual)
- Study completion
- 8 Jan 2015 (actual)
- First posted
- 10 Dec 2013 (estimated)
- Results
- Posted 26 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GWP42003 1000 milligrams (mg)/day | Active comparator | Drug: GWP42003Participants 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. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: Placebo controlPlacebo oral solution (0 milligrams [mg]/mL CBD) contained the excipients sesame oil, ethanol, sucralose, and strawberry flavoring. | Drug | Placebo |
| GWP42003Also: CannabidiolGWP42003 was an oral solution containing 100 mg/mL CBD dissolved in the excipients sesame oil, ethanol, sucralose and strawberry flavoring. | Drug | GWP42003 1000 milligrams (mg)/day |
Primary outcome
Change From Baseline To End Of Treatment (Day 43) In Positive And Negative Syndrome Scale (PANSS) Total Score
Time frame: 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.
Percentage Of PANSS Total Score Responders At End Of Treatment (Day 43)
Time frame: 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.
Change From Baseline To The End Of Treatment (Day 43) In PANSS 'P' Score
Time frame: 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.
Change From Baseline To The End Of Treatment (Day 43) In PANSS 'N' Score
Time frame: 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.
Change From Baseline To The End Of Treatment (Day 43) In PANSS 'G' Score
Time frame: 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.
Change From Baseline To The End Of Treatment (Day 43) In The Scale For The Assessment Of Negative Symptoms (SANS)
Time frame: 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.
Change From Baseline To The End Of Treatment (Day 43) In The Clinical Global Impression Severity Scale (CGI-S)
Time frame: 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.
Clinical Global Impression Improvement Scale (CGI-I) Values At Day 8 And End Of Treatment (Day 43)
Time frame: 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.
Change From Baseline To The End Of Treatment (Day 43) In Brief Assessment Of Cognition In Schizophrenia (BACS) Score
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29241357McGuire 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GWP42003 in people with Schizophrenia and Schizophrenia-related Psychotic Disorder, run by Jazz Pharmaceuticals at 14 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Poland, Romania, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline To End Of Treatment (Day 43) In Positive And Negative Syndrome Scale (PANSS) Total Score (time frame: Day 1 through Day 43). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02006628, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.