E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 16.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10039628 |
E.1.2 | Term | Schizophrenia and other psychotic disorders |
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 determine whether the addition of the molecule Cannabidiol (CBD) leads to improvement in the severity of core psychotic symptom, in patients experiencing their first psychotic episode who have failed to recover despite treatment with at least one standard anti-psychotic drug. |
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E.2.2 | Secondary objectives of the trial |
To determine whether the addition of CBD to an existing antipsychotic treatment regime offers 'protection' against the metabolic consequences associated with standard anti-psychotic treatment, namely weight-gain, hyperglycaemia and dyslipidaemia.
To determine whether measures of brain activity using magnetic resonance imaging can predict response to CBD, and whether these measures change with response to CBD. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Aged 18-60 (inclusive) meeting DSM IV criteria for schizophrenia.
- Previous treatment with >=1 anti-psychotic at therapeutic doses for >= 5 weeks.
- Not currently in remission according to established criteria1.
- Willing to provide written informed consent.
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E.4 | Principal exclusion criteria |
- Pregnancy, lactation in women.
- Participants (both men and women) of child bearing potential who are not willing to use reliable contraceptive precautions for the treatment duration and for three months after discontinuation of therapy.
- Major physical illness.
- Mental retardation.
- Entry global Assessment of Functioning Scale (GAF) <20,
- Alcohol or drug dependence.
- Concomitant anti-depressant/anti-convulsant treatment for 2-months prior to study entry.
- Suicidal/homicidal traits.
- History of non-compliance.
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E.5 End points |
E.5.1 | Primary end point(s) |
Scores on core psychotic symptoms as measured by the PANSS, GAF, CGI, MADRS and CAPE rating scales. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Screening, baseline, 2 weeks, 4 weeks, 6 weeks |
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E.5.2 | Secondary end point(s) |
Metabolic indices (body weight, fasting plasma glucose, lipids & insulin, HBA1C) and plasma CBD concentrations. Urinary drug screens and vital signs
Brain glutamate measures with 1H-MRS, blood flow using ASL and BOLD response with fMRI imaging methods. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Metabolic indices at baseline and 6 weeks.
Urinary drug screen at screening, baseline, 2 weeks, 4 weeks and 6 weeks.
Brain glutamate measures with 1H-MRS, blood flow using ASL and BOLD response with fMRI imaging methods at baseline (week 0) and week 6. |
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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 | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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 |