Cannabidiol as an add-on therapy in treatment-refractory psychotic disorders

Phase 1

Conditions: Schizophrenia
MedDRA version: 16.1Level: HLGTClassification code 10039628Term: Schizophrenia and other psychotic disordersSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2013-000240-26-GB

Lead Sponsor: King's College London

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: 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.<br><br>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.;Primary end point(s): Scores on core psychotic symptoms as measured by the PANSS, GAF, CGI, MADRS and CAPE rating scales.;Timepoint(s) of evaluation of this end point: Screening, baseline, 2 weeks, 4 weeks, 6 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Metabolic indices (body weight, fasting plasma glucose, lipids & insulin, HBA1C) and plasma CBD concentrations. Urinary drug screens and vital signs<br><br>Brain glutamate measures with 1H-MRS, blood flow using ASL and BOLD response with fMRI imaging methods.;Timepoint(s) of evaluation of this end point: Metabolic indices at baseline and 6 weeks.<br>Urinary drug screen at screening, baseline, 2 weeks, 4 weeks and 6 weeks.<br>Brain glutamate measures with 1H-MRS, blood flow using ASL and BOLD response with fMRI imaging methods at baseline (week 0) and week 6.