NCT02926859Active, not recruitingPhase 2
Enhancing Recovery in Early Schizophrenia
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
Source: ClinicalTrials.gov · Last updated 3 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 7 Jul 2016
- Start date
- 8 Apr 2017
- Primary completion date
- Dec 2027
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Diseases
- Schizophrenia
- NCT number
- NCT02926859
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 180
- From 8 Apr 2017 to the primary completion date, Dec 2027
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- positive urine drug-screening for illicit drugs at screening (except cannabinoids and benzodiazepines)
Other illness
- other relevant neurological or other medical disorders
Other
- Lack of accountability
- serious suicidal risk at screening visit
- other relevant interferences of axis 1 according to diagnostic evaluation (MINI) including residual forms of schizophrenia.
- pregnancy or lactation.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Psychiatry, Psychotherapy, and Psychosomatics, RWTH Aachen Coordinator of this site? Confirm its status | Aachen | Germany | Unknown status |
| Dept. of Psychiatry and Psychotherapy, Charité, Campus Charité-Mitte Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Dept. of Psychiatry and Psychotherapy, University Hospital of Cologne Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| Department of Psychiatry und Psychotherapy, University Hospital Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health Coordinator of this site? Confirm its status | Mannheim | Germany | Unknown status |
| Dept. of Psychiatry and Psychotherapy, Ludwig-Maximillians-University Munich Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.