Enhancing Recovery in Early Schizophrenia

Launched by CENTRAL INSTITUTE OF MENTAL HEALTH, MANNHEIM · Oct 4, 2016

Keywords

ClinConnect Summary

This clinical trial, titled "Enhancing Recovery in Early Schizophrenia," is studying a treatment called cannabidiol (CBD) to see if it can help people with schizophrenia. Schizophrenia is a serious mental health condition that affects how a person thinks, feels, and behaves. Current treatments often have unwanted side effects, so researchers are looking for safer options. In this trial, CBD will be compared to a placebo (a "sugar pill" with no active ingredients) while participants continue their regular treatment with medications like amisulpride, aripiprazole, olanzapine, quetiapine, or risperidone. The goal is to find out if CBD can improve symptoms without causing the usual side effects.

To be eligible for the study, participants need to be between 18 and 65 years old and must have been diagnosed with schizophrenia within the last seven years. They should also be stable on their current medication for at least four weeks and meet certain health criteria. Participants can expect to be part of a 12-month study where they will receive either CBD or a placebo, and their symptoms will be closely monitored. It's important to note that while CBD has shown promise in earlier studies, more research is needed to confirm its safety and effectiveness over the long term.

Gender

ALL

Eligibility criteria

• 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.