Enhancing Recovery in Early Schizophrenia - a Multi-center, Two-arm, Double-blind, Randomized Phase II Trial Investigating Cannabidiol Vs. Placebo As an Add-on to an Individualized Antipsychotic Treatment

Who is this study for? Patients with Schizophrenia
What treatments are being studied? Cannabidiol as Add-On
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Germany
Department of Psychiatry, Psychotherapy, and Psychosomatics, RWTH Aachen
RECRUITING
Aachen
Dept. of Psychiatry and Psychotherapy, Charité, Campus Charité-Mitte
RECRUITING
Berlin
Dept. of Psychiatry and Psychotherapy, University Hospital of Cologne
RECRUITING
Cologne
Department of Psychiatry und Psychotherapy, University Hospital Hamburg-Eppendorf
RECRUITING
Hamburg
Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health
RECRUITING
Mannheim
Dept. of Psychiatry and Psychotherapy, Ludwig-Maximillians-University Munich
NOT_YET_RECRUITING
Munich
Contact Information
Primary
F. Markus Leweke, MD
leweke@cimh.de
+49 621 1703 2321
Backup
Cathrin Rohleder, PhD
rohleder@cimh.de
+49 621 1703 2333
Time Frame
Start Date: 2017-04-08
Estimated Completion Date: 2026-06
Participants
Target number of participants: 180
Treatments
Experimental: Cannabidiol
Cannabidiol as add-on to individualized pharmacological treatment
Placebo_comparator: Placebo
Placebo as add-on to individualized pharmacological treatment
Related Therapeutic Areas
Sponsors
Leads: Central Institute of Mental Health, Mannheim

This content was sourced from clinicaltrials.gov