Evaluation of the necessity of a pharmacological treatment with antipsychotics for the prevention of relapse in long-term stabilized schizophrenic patients: a randomized, single-blind, longitudinal trial

Phase 1

• Conditions: schizophrenia or schizoaffective disorder in remission for at least 3 years under a stable antipsychotic medication.; MedDRA version: 17.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 17.0Level: PTClassification code 10039621Term: Schizoaffective disorderSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2013-000338-37-DE
• Lead Sponsor: Technische Universität München, vertreten durch das Klinikum rechts der Isar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-23
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Male or female patients, 18 to 65 years of age.
2. Diagnosis of schizophrenia or schizoaffective disorder.
3. The participants have to be in remission for at least 3 years (i.e. no psychiatric
hospitalisation) under a stable antipsychotic medication.
4. Able to give informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Actively suicidal.
2. Serious medical illnesses.
3. Known non-complience concerning the medication.
4. Medication with clozapin.
5. Patients with substance dependence other than nicotine or caffeine within 6 months prior to baseline.
6. Pregnancy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the Trial is to evaluate for the first time employing high-Quality methodology, how long an antipsychotic relapse-prevention should be continued and to which time a patient is protected enough, so that a withdrawal of the medication seems appropriate. Relapse is defined as primary outcome.;Secondary Objective: Secondary objectives of the trial are psychiatric rehospitalisation, changes in psychiatric rating scales, quality of life, ability to work, personal and social functioning, adherence, drop-outs, movement disorders, and the occurrence of specific adverse effects.;Primary end point(s): Relapse is defined as primary outcome. ;Timepoint(s) of evaluation of this end point: every two weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary outcomes are psychiatric rehospitalisation, changes in psychiatric rating scales, quality of life, ability to work, personal and social functioning, adherence, drop-outs, movement disorders, and the occurrence of specific adverse effects.;Timepoint(s) of evaluation of this end point: most of the secondary endpoints will be evaluated every two weeks.