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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000240-26-GB

Enrollment

Unknown

Registered

2013-10-03

Start date

2013-10-29

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia MedDRA version: 16.1 Level: HLGT Classification code 10039628 Term: Schizophrenia and other psychotic disorders System Organ Class: 10037175 - Psychiatric disorders

Interventions

Product Name: Cannabidiol Pharmaceutical Form: Capsule INN or Proposed INN: Not applicable CAS Number: 13956-29-1 Current Sponsor code: Cannabidiol Other descriptive name: CANNABIDIOL Concentration un

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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. 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	—

Measure

Time frame

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. 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

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Secondary

Measure	Time frame
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.;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.	—

Measure

Time frame

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.;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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Countries

United Kingdom

Contacts

Public ContactPaul Morrison

King's College London

paul.morrison@kcl.ac.uk4402078480057

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026