Evaluation of the necessity of long-term pharmacological treatment withantipsychotics for the prevention of relapse in long-term stabilizedschizophrenic patients: a randomized, single-blind, longitudinal trial

Phase 4

• Conditions: F20; F25; Schizophrenia; Schizoaffective disorders

• Registration Number: DRKS00006878
• Lead Sponsor: Klinikum rechts der Isar der TU München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 25

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

- 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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relapse is defined as primary outcome.<br>The criterion is measured at every visit (every two weeks) two weeks with two criteria, both have to be fullfilled:<br>a) Score =4 (moderate) for at least two of the following PANSS-items :<br>Delusions (P1), Conceptual disorganisation (P2), Halluzinations (P3), Mannerisms and posturing (G5) and Unusual thought content (G9) (PANSS; Kay et al., 1987)<br>b) Score =4 on the Clinical Global Impression Severity Scale (CGI-S; Guy, 1976b)