F20 F25
Conditions
Interventions
Group 1: Intervention group: guided discontinuation or dose-reduction of the current antipsychotic medication. The antipsychotic drug used before study start will be discontinued gradually under medic
Sponsors
Klinikum rechts der Isar der TU München
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: - Male or female patients, 18 to 65 years of age. - 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, 1976b) - Able to give informed consent.
Exclusion criteria
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 |
|---|---|
| Relapse is defined as primary outcome. The criterion is measured at every visit (every two weeks) two weeks with two criteria, both have to be fullfilled: a) 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) b) Score =4 on the "Clinical Global Impression Severity Scale" (CGI-S; Guy, 1976b) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Psychiatric rehospitalisation (every visit, every 2 weeks) - Totalscore of Positive and Negative Syndrome Scale (PANSS) (Baseline, then every 4 weeks) - Occurence of specific adverse effects (open interview) (Baseline,then every 4 weeks) - Clinical Global Impression – Severity Scale (CGI-S) (Baseline, then every 4 weeks) - “Quality of life” measured by the questionnaire “Subjective well-being under neuroleptics scale” (SW-N) (Baseline, and after 12 and 26 weeks) - Status of occupation (Baseline, and after 12 and 26 weeks) - Personal and Social Performance (Personal and Social Performance Scale [PSP]) (Baseline, and after 12 and 26 weeks) - Adherence/Attitude of patients towards medication (Medication Adherence Rating Scale [MARS]) (Baseline, and after 12 and 26 weeks) - Drop-outs total and due to specific reasons - Movement disorders (Abnormal Involuntary Movement Scale [AIMS]) (Baseline, and after 12 and 26 weeks) - Weight change (Baseline, and after 12 and 26 weeks) | — |
Countries
Germany
Contacts
Public ContactStefan Leucht
Klinik für Psychiatrie und PsychotherapieTechnische Universität MünchenKlinikum rechts der Isar
Outcome results
None listed