Status:
COMPLETED
Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics in Schizophrenic Patients
Lead Sponsor:
Technical University of Munich
Conditions:
Schizophrenia
Schizophrenia and Disorders With Psychotic Features
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The main objective of the trial is to evaluate, how long an antipsychotic relapse-prevention should be continued and to which time a patient with schizophrenia is protected enough, so that a withdrawa...
Detailed Description
The main objective of the trial is to evaluate for the first time, how long an antipsychotic relapse-prevention should be continued and to which time a patient is protected enough, so that a guided wi...
Eligibility Criteria
Inclusion
- Diagnosis of schizophrenia or schizoaffective disorder
- The participants have to be in remission for at least 3 years (i.e. no psychiatric hospitalisation) under a stable antipsychotic medication. Remission will be measured using the remission criteria by Andreasen et al. (2005) Score ≤3 for the items concerning psychosis of the "Positive and Negative Syndrom Scale" (PANSS; Kay et al., 1987): "Delusions" (P1), "Conceptual disorganisation" (P2), "Halluzinations" (P3), "Mannerisms and posturing" (G5) and "Unusual thought content" (G9) and a score ≤3 on the "Clinical Global Impression Severity Scale" (CGI-S; Guy, 1976)
- Able to give informed consent
Exclusion
- Actively suicidal
- Serious medical illnesses
- Known non-complience concerning the medication
- Medication with clozapin
- Medication with antidepressants and mood stabilisors that were initiated during the last 6 weeks before study enrollment
- Patients with substance dependence other than nicotine or caffeine within 6 months prior to baseline
- Unability to give informed consent
- Pregnancy
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2016
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT02307396
Start Date
February 1 2015
End Date
June 22 2016
Last Update
October 11 2018
Active Locations (1)
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1
Psychiatrische Klinik und Poliklinik fuer Psychiatrie und Psychotherapie der Technischen Universitaet Muenchen am Klinikum rechts der Isar
Munich, Bavaria, Germany, 81675