Schizophrenia, Schizophrenia and Disorders With Psychotic Features, Schizoaffective Disorders
Conditions
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 withdrawal or reduction of the medication seems appropriate. Relapse is defined as primary outcome.
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 withdrawal or reduction of the medication seems appropriate. Relapse is defined as primary outcome. We include patients with schizophrenia or schizoaffective disorder in remission for at least 3 years under a stable antipsychotic medication.
Interventions
DRUGOlanzapine
DRUGAmisulpride
DRUGRisperidone
DRUGHaloperidol
DRUGQuetiapine
DRUGPerphenazine
DRUGSulpiride
DRUGbromperidol
DRUGZuclopenthixol
DRUGThioridazine
DRUGPaliperidone
DRUGZiprasidone
DRUGBenperidol
DRUGFluspirilene
DRUGPimozide
DRUGPerazine
DRUGFluphenazine
DRUGFlupentixole
DRUGSertindole
Sponsors
Technical University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapse | Every 2 weeks up to 26 weeks | The criterion is measured at every visit (every two weeks) two weeks with two criteria, both have to be fullfilled: 1. Score ≥4 (moderate) for at least two of the following PANSS-items : Delusions (P1), Conceptual disorganisation (P2), Halluzinations (P3), Mannerisms and posturing (G5) and Unusual thought content (G9) (PANSS; Kay et al., 1987) 2. Score ≥4 on the Clinical Global Impression Severity Scale (CGI-S; Guy, 1976b) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Totalscore of Positive and Negative Syndrome Scale (PANSS) | Baseline, then every 4 weeks up to 26 weeks | PANSS-Scale |
| Occurence of specific adverse effects (open interview) | Baseline,then every 4 weeks up to 26 weeks | — |
| Clinical Global Impression - Severity Scale (CGI-S) | Baseline, then every 4 weeks up to 26 weeks | CGI-I Scale |
| Quality of life measured by the questionnaire Subjective well-being under neuroleptics scale (SW-N) | Baseline, and after 12 and 26 weeks | SW-N-Scale |
| Status of occupation | Baseline, and after 12 and 26 weeks | — |
| Psychiatric rehospitalisation | Every 2 weeks up to 26 weeks | — |
| Adherence/Attitude of patients towards medication (Medication Adherence Rating Scale [MARS]) | Baseline, and after 12 and 26 weeks | MARS-Scale |
| Drop-outs total and due to specific reasons | Every 2 weeks up to 26 weeks | — |
| Movement disorders (Abnormal Involuntary Movement Scale [AIMS]) | Baseline, and after 12 and 26 weeks | AIMS-Scale |
| Weight change | Baseline, and after 12 and 26 weeks | — |
| Personal and Social Performance (Personal and Social Performance Scale [PSP]) | Baseline, and after 12 and 26 weeks | PSP-Scale |
Countries
Germany
Outcome results
None listed