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Enhancing Recovery in Early Schizophrenia

NCT ID: NCT02926859

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-08

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cannabidiol

Cannabidiol as add-on to individualized pharmacological treatment

Group Type EXPERIMENTAL

Cannabidiol as add-on

Intervention Type 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

Placebo

Placebo as add-on to individualized pharmacological treatment

Group Type PLACEBO_COMPARATOR

Placebo as add-on

Intervention Type 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

Interventions

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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

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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F. Markus Leweke, MD

Role: PRINCIPAL_INVESTIGATOR

Central Institute of Mental Health

Locations

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

Mannheim, Baden-Wurttemberg, Germany

Site Status RECRUITING

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

Munich, Bavaria, Germany

Site Status NOT_YET_RECRUITING

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

Berlin, B, Germany

Site Status RECRUITING

Department of Psychiatry, Psychotherapy, and Psychosomatics, RWTH Aachen

Aachen, North Rhine-Westphalia, Germany

Site Status RECRUITING

Dept. of Psychiatry and Psychotherapy, University Hospital of Cologne

Cologne, North Rhine-Westphalia, Germany

Site Status RECRUITING

Department of Psychiatry und Psychotherapy, University Hospital Hamburg-Eppendorf

Hamburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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F. Markus Leweke, MD

Role: CONTACT

Phone: +49 621 1703 2321

Email: [email protected]

Cathrin Rohleder, PhD

Role: CONTACT

Phone: +49 621 1703 2333

Email: [email protected]

Facility Contacts

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F. Markus Leweke, MD

Role: primary

F. Markus Leweke, MD

Role: backup

Peter Falkai, MD

Role: primary

Peter Falkai, MD

Role: backup

Henrik Walter, MD, PhD

Role: primary

Henrik Walter, MD, PhD

Role: backup

Tanja Veselinovic, MD

Role: primary

Tanja Veselinovic, MD

Role: backup

Joseph Kambeitz, MD

Role: primary

Joseph Kambeitz, MD

Role: backup

Daniel Schöttle, MD

Role: primary

Other Identifiers

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CBD-ESPRIT

Identifier Type: -

Identifier Source: org_study_id