Enhancing recovery in early schizophrenia –a multi-center, two-arm, double-blind, randomized clinical trial investigating cannabidiol vs. placebo as an add-on to an individualized antipsychotic treatment

Phase 2

Recruiting

Conditions: F20
Schizophrenia

Registration Number: DRKS00011151

Lead Sponsor: Zentralinstitut für Seelische Gesundheit

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 180

Inclusion Criteria

• Informed consent given by the subject
• DSM-IV-TR diagnosis of schizophrenic psychosis (295.10, 295.20, 295.30, 295.90)
• First documented diagnosis of schizophrenia must not be no older than seven years
• Patients must receive a stable dose of amisulpride (50 to 1200 mg/day), aripiprazole (10 to 30 mg/day), olanzapine (5 to 20 mg/day), quetiapine (300 to 750 mg/day), or risperidone (1 to 10 mg/day) (TAU: treatment as usual) at least four weeks prior to inclusion in the study to ensure that the maximal effect of the previous medication has been received.
• Age 18 to 65 years, male or female.
• Initial PANSS total score of = 75 at baseline.
• Female patients of childbearing potential need to utilize a proper method of contraception.
• Body Mass Index between 18 and 40.

Exclusion Criteria

• Lack of accountability (assessed by an independent psychiatrist)
• Positive urine drug-screening for illicit drugs at screening (except cannabinoids and benzodiazepines).
• Serious suicidal risk at screening visit (Subject to investigator’s judgement).
• Other relevant interferences of axis 1 (e.g. serious depression) according to diagnostic evaluation (MINI) including residual forms of schizophrenia.
• Other relevant neurological or other medical disorders.
• Pregnancy, determined through a ß-HCG pregnancy test, or lactation

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause discontinuation within 12 month

Secondary Outcome Measures

Name	Time	Method
• Improvement in Psychopathology from baseline over time (particularly month 6) (PANSS, CGI, BSI-53, FROGS), social and occupational functioning (GAF, PSP, EMA) and quality of life (WHOQUOL-Bref, LQLP).<br><br>• Changes from baseline over time (particularly month 6) in the Calgary Depression Scale for Schizophrenia (CDSS).<br><br>• Changes from baseline over time (particularly month 6) in Neurocogniton (B-CATS, BACS, UPSA-B, MASC and PFA).<br><br>• Treatment adherence.<br><br>• Changes of cumulative dose of concomitant or rescue medication.<br><br>• Changes of biomarkers<br><br>• Side effects (UKU, AIMS, EPS, C-SSRS, BMI, ECG, prolactin) compared to baseline over time (particularly month 6) .<br><br>• Detailed laboratory assessments.