Enhancing Recovery in Early Schizophrenia

NCT02926859 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: CBD-ESPRIT
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• All-cause discontinuation

  within 12 month

Secondary Outcomes (18)

• Improvement in Psychopathology assessed by PANSS

  6, 9 and 12 month

• Improvement in Psychopathology assessed by CGI

  6, 9 and 12 month

• Improvement in Psychopathology assessed by BSI-53

  6, 9 and 12 month

• Improvement in Psychopathology assessed by FROGS

  6, 9 and 12 month

• Changes from baseline in Depression Scale

  6, 9 and 12 month

Other Outcomes (8)

• Side effects: weight gain

  6, 9 and 12 month

• Side effects: Vital Signs

  6, 9 and 12 month

• Side effects: UKU Side Effect rating scale

  6, 9 and 12 month

Study Arms (2)

Cannabidiol

EXPERIMENTAL

Cannabidiol as add-on to individualized pharmacological treatment

Drug: Cannabidiol as add-on

Placebo

PLACEBO COMPARATOR

Placebo as add-on to individualized pharmacological treatment

Drug: Placebo as add-on

Interventions

Cannabidiol as add-on DRUG

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

Cannabidiol

Placebo as add-on DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Initial PANSS total score of ≤ 75 at baseline.
• proper contraception in female patients of childbearing potential
• body mass index between 18 and 40.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Institute of Mental Health, Mannheim: lead

Study Sites (6)

Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health

Mannheim, Baden-Wurttemberg, 68159, Germany

Location

Dept. of Psychiatry and Psychotherapy, Ludwig-Maximillians-University Munich

Munich, Bavaria, 80336, Germany

Location

Dept. of Psychiatry and Psychotherapy, Charité, Campus Charité-Mitte

Berlin, B, 10117, Germany

Location

Department of Psychiatry, Psychotherapy, and Psychosomatics, RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Dept. of Psychiatry and Psychotherapy, University Hospital of Cologne

Cologne, North Rhine-Westphalia, 50924, Germany

Location

Department of Psychiatry und Psychotherapy, University Hospital Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• F. Markus Leweke, MD

  Central Institute of Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2016
• First Posted: October 6, 2016
• Study Start: April 8, 2017
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

DE (6)