Enhancing Recovery in Early Schizophrenia

NCT02926859 · tracked via the Priya Life Science Germany tracker

Sponsor

Central Institute of Mental Health, Mannheim

Phase

Phase 2

Started

2017-04-08

Last updated

2026-02-03

Condition(s) studied

Schizophrenia

Investigational drug(s) / intervention(s)

Cannabidiol as add-onPlacebo as add-on

Cannabidiol as add-on: Cannabidiol capsules 2x200 mg twice a day as add-on to individualized pharmacological treatment with either amisulpride, aripiprazole, olanzapine, quetiapine or risperidone over 26 weeks

Placebo as add-on: Placebo capsules 2x200 mg twice a day as add-on to individualized pharmacological treatment with either amisulpride, aripiprazole, olanzapine, quetiapine or risperidone over 26 weeks

Study summary

Current antipsychotic treatments of schizophrenia are only partially effective, and their use is often associated with serious side effects. Cannabidiol is a natural counterpart of the psychoactive component of marijuana, delta-9- tetrahydrocannabinol and has no psychotomimetic or addictive properties. In a controlled clinical trial of cannabidiol versus amisulpride in acute paranoid schizophrenia we showed a statistically significant clinical improvement in all symptoms clusters of schizophrenia compared to baseline with either treatment. Cannabidiol displayed a significantly superior side-effect profile in particular regarding prolactin elevation, extrapyramidal symptoms and weight gain. The favorable side-effect profile and potentially novel mechanism of action identify this molecule as a potential antipsychotic. However, long-term safety and efficacy data is still lacking. This study is to evaluate the efficacy and safety of the novel compound cannabidiol in the maintenance treatment of schizophrenia in comparison to placebo as an add-on to an established treatment with either amisulpride, aripiprazole, olanzapine, quetiapine or risperidone, in a 12-months, double-blind, parallel-group, randomized, placebo-controlled clinical trial. Thereby, relevant data on cannabidiol's antipsychotic potential will be gained.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: * Informed consent given by the subject * DSM-IV-TR diagnosis of schizophrenic psychosis (295.10-30, 295.90) * First documented diagnosis of schizophrenia must not be no older than seven years. * Patients must receive a stable dose of amisulpride, aripiprazole, olanzapine, quetiapine or risperidone (TAU: treatment as usual) at least 4 weeks prior to inclusion in the study to ensure that the maximal effect of the previous medication has been received. * Initial PANSS total score of ≤ 75 at baseline. * proper contraception in female patients of childbearing potential * body mass index between 18 and 40. Exclusion Criteria: * Lack of accountability * positive urine drug-screening for illicit drugs at screening (except cannabinoids and benzodiazepines) * serious suicidal risk at screening visit * other relevant interferences of axis 1 according to diagnostic evaluation (MINI) including residual forms of schizophrenia. * other relevant neurological or other medical disorders * pregnancy or lactation.

Primary outcome measure(s)

All-cause discontinuation — within 12 month

Trial sites (6)

Facility	City	Region
Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health	Mannheim	Baden-Wurttemberg
Dept. of Psychiatry and Psychotherapy, Ludwig-Maximillians-University Munich	Munich	Bavaria
Dept. of Psychiatry and Psychotherapy, Charité, Campus Charité-Mitte	Berlin	B
Department of Psychiatry, Psychotherapy, and Psychosomatics, RWTH Aachen	Aachen	North Rhine-Westphalia
Dept. of Psychiatry and Psychotherapy, University Hospital of Cologne	Cologne	North Rhine-Westphalia
Department of Psychiatry und Psychotherapy, University Hospital Hamburg-Eppendorf	Hamburg	Germany

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02926859 on ClinicalTrials.gov ↗ ← All trials in Germany