Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics in Schizophrenic Patients

Technical University of Munich21 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Schizophrenia Schizophrenia and Disorders With Psychotic Features Schizoaffective Disorders

Interventions

OlanzapineDRUG

AmisulprideDRUG

RisperidoneDRUG

HaloperidolDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Psychiatrische Klinik und Poliklinik fuer Psychiatrie und Psychotherapie der Technischen Universitaet Muenchen am Klinikum rechts der Isar

Munich, Bavaria, Germany

Outcomes

Primary Outcomes

Relapse

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)

Time frame: Every 2 weeks up to 26 weeks

Secondary Outcomes

Psychiatric rehospitalisation

Time frame: Every 2 weeks up to 26 weeks

Totalscore of Positive and Negative Syndrome Scale (PANSS)

PANSS-Scale

Time frame: Baseline, then every 4 weeks up to 26 weeks

Occurence of specific adverse effects (open interview)

Time frame: Baseline,then every 4 weeks up to 26 weeks

Clinical Global Impression - Severity Scale (CGI-S)

CGI-I Scale

Time frame: Baseline, then every 4 weeks up to 26 weeks

"Quality of life" measured by the questionnaire "Subjective well-being under neuroleptics scale" (SW-N)

SW-N-Scale

Time frame: Baseline, and after 12 and 26 weeks

Status of occupation

Time frame: Baseline, and after 12 and 26 weeks

Personal and Social Performance (Personal and Social Performance Scale [PSP])

PSP-Scale

Data from ClinicalTrials.gov

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