DRKS00011151
Recruiting
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- F20
- Sponsor
- Zentralinstitut für Seelische Gesundheit
- Enrollment
- 180
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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