Enhancing Recovery in Early Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02926859
• Other study ID #: CBD-ESPRIT
• Status: Recruiting
• Phase: Phase 2
• Start date: April 8, 2017
• Est. completion date: December 2025

Study information

• Verified date: September 2023
• Source: Central Institute of Mental Health, Mannheim
• Contact: F. Markus Leweke, MD
• Phone: +49 621 1703 2321
• Email: leweke[@]cimh.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Germany	Department of Psychiatry, Psychotherapy, and Psychosomatics, RWTH Aachen	Aachen	NRW
Germany	Dept. of Psychiatry and Psychotherapy, Charité, Campus Charité-Mitte	Berlin	B
Germany	Dept. of Psychiatry and Psychotherapy, University Hospital of Cologne	Cologne	NRW
Germany	Department of Psychiatry und Psychotherapy, University Hospital Hamburg-Eppendorf	Hamburg
Germany	Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health	Mannheim	BW
Germany	Dept. of Psychiatry and Psychotherapy, Ludwig-Maximillians-University Munich	Munich	BY

Sponsors (1)

Lead Sponsor	Collaborator
Central Institute of Mental Health, Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Side effects: weight gain	Body Mass Index, abdominal girth	6, 9 and 12 month
Other	Side effects: Vital Signs	heart rate, blood pressure, electrocardiography	6, 9 and 12 month
Other	Side effects: UKU Side Effect rating scale		6, 9 and 12 month
Other	Side effects: Abnormal Involuntary Movement Scale (AIMS)		6, 9 and 12 month
Other	Side effects: Evaluation of extrapyramidal symptoms (EPS)		6, 9 and 12 month
Other	Side effects: physical and neurological examination		6, 9 and 12 month
Other	Standard blood tests		6, 9 and 12 month
Other	Columbia Suicidality Sverity Rating Scale (C-SSRS)		6, 9 and 12 month
Primary	All-cause discontinuation		within 12 month
Secondary	Improvement in Psychopathology assessed by PANSS	Positive and Negative Syndrome Scale (PANSS)	6, 9 and 12 month
Secondary	Improvement in Psychopathology assessed by CGI	Clinical Global Impression (CGI)	6, 9 and 12 month
Secondary	Improvement in Psychopathology assessed by BSI-53	Brief Symptom Inventory (BSI-53)	6, 9 and 12 month
Secondary	Improvement in Psychopathology assessed by FROGS	Functional Remission of General Schizophrenia (FROGS)	6, 9 and 12 month
Secondary	Changes from baseline in Depression Scale	Calgary Depression Scale for Schizophrenia (CDSS)	6, 9 and 12 month
Secondary	Improvement in social and occupational functioning assessed by GAF	Global Assessment of Functioning (GAF)	6, 9 and 12 month
Secondary	Improvement in social and occupational functioning assessed by PSP	Personal and Social Performance Scale (PSP)	6, 9 and 12 month
Secondary	Improvement in social and occupational functioning assessed by EMA	Ecological Momentary Assessment (EMA)	6, 9 and 12 month
Secondary	Improvement in Quality of life assessed by WHOQUOL-Bref	WHO Quality of Life-Bref (WHOQUOL-Bref)	6, 9 and 12 month
Secondary	Improvement in Quality of life assessed by LQLP	Lancashire Quality of Life Profile (LQLP)	6, 9 and 12 month
Secondary	Changes from baseline in Neurocognition assessed by B-CATS	Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)	6, 9 and 12 month
Secondary	Changes from baseline in Neurocognition assessed by BACS	Brief Assessment of Cognition in Schizophrenia (BACS)	6, 9 and 12 month
Secondary	Changes from baseline in Neurocognition assessed by UPSA-B	University of California San Diego Performance based Skills Assessment (UPSA-B)	6, 9 and 12 month
Secondary	Changes from baseline in Neurocognition assessed by MASC	Movie for the Assessment of Social Cognition (MASC)	6, 9 and 12 month
Secondary	Changes from baseline in Neurocognition assessed by PFA	Pictures of Facial Affect (PFA)	6, 9 and 12 month
Secondary	Treatment adherence		6, 9 and 12 month
Secondary	Changes in Cumulative dose of concomitant or rescue medication		6, 9 and 12 month
Secondary	Changes of Biomarker: alterations of endocannabinoids and lipdomic profiling		6, 9 and 12 month