E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Schizophrenia or related psychotic disorder |
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E.1.1.1 | Medical condition in easily understood language |
Schizophrenia or related psychotic disorder |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039626 |
E.1.2 | Term | Schizophrenia |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of GWP42003 as an adjunctive therapy to first line treatment in alleviating symptoms of schizophrenia or related psychotic disorder compared with placebo.
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Participant is willing and able to give written informed consent for participation in the study and does not require involuntary treatment.
-Male or female participant(s) aged 18 to 65 years.
-Participant is able (in the investigator’s opinion) and willing to comply with all study requirements.
-Participant is 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 must have been treated for a minimum of four-weeks and be on a stable dose of their current AP medication.
-Participant must have shown the capacity to respond at least partially to first line AP medication in the opinion of the investigator.
-Participant must be able to remain stable on their dose of AP and concomitant medications for the duration of the study, in the opinion of the investigator.
-Participant is willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable in individual countries.
-Participant is willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study.
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E.4 | Principal exclusion criteria |
-Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the Investigational Medicinal Products (IMPs).
-Participant has a PANSS Total score of < 60 at Visit 1.
-Participant presents with a current clinical picture and/or history that is consistent with:
delirium or dementia
acute drug induced psychosis
bipolar disorder
-Participant is taking more the one AP medication during the study.
-Female participants of child bearing potential and male participants whose partner is of child bearing potential, unless willing to ensure that they or their partner use effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for three months thereafter (however a male condom should not be used in conjunction with a female condom).
-Female participant who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.
-Participants who have received an IMP within 30 days prior to the screening visit.
-Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.
-Following a physical examination, the participant has any abnormalities that, in the opinion of the investigator would prevent the participant from safe participation in the study.
-Unwilling to abstain from donation of blood during the study.
-Travel outside the country of residence planned during the study.
-Participants previously randomised into this study.
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E.5 End points |
E.5.1 | Primary end point(s) |
The efficacy of GWP42003 will also be evaluated through the following instruments and measures To evaluate the efficacy of GWP42003 as an adjunctive therapy to first line treatment in alleviating symptoms of schizophrenia or related psychotic disorder compared with placebo on the following key instruments and measures:
- PANSS Total score
- Responder analysis of PANSS Total score
- PANSS ‘P’
- PANSS ‘N’
- PANSS ‘G’
- SANS
- CGI-I
- GAF
- SAS
- BACS
- PGIC of sleep
- HDL-cholesterol levels
To evaluate the efficacy of GWP42003 on the following other instruments and measures:
- CGI-S
- PGIC of functioning
- CGIC of functioning and sleep (if applicable)
- Dependence disorder questionnaire (if applicable)
- Body weight, waist measurement and BMI
- LFTs and hormonal marker serum prolactin
- Markers of inflammation including cytokines IL-2, IL-6 and IFNγ and CRP
- Cannabinoid plasma levels
- PANSS scores (Total, ‘G’, ‘P’, ‘N’ scores) and SANS will be correlated with plasma GWP42003 levels at end of week 3 (Visit 3) and end of treatment (Visit 4). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Assessed at: Visit 1 (Day 1); Visit 2 (Day 8); Visit 3 (Day 22) and Visit 4 (Day 43) |
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E.5.2 | Secondary end point(s) |
Not Applicable - This study does not have primary or secondary endpoints, but has been split into ‘key’ and ‘other’ endpoints to reflect the exploratory nature of this phase II trial. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |