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

Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics for the Prevention of Relapse in Long-term Stabilized Schizophrenic Patients: a Randomized, Single-blind, Longitudinal Trial

Sponsors

Lead Sponsor: Technische Universität München

Source Technische Universität München
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.

Overall Status Completed
Start Date February 1, 2015
Completion Date June 22, 2016
Primary Completion Date June 22, 2016
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Relapse Every 2 weeks up to 26 weeks
Secondary Outcome
Measure Time Frame
Psychiatric rehospitalisation Every 2 weeks up to 26 weeks
Totalscore of Positive and Negative Syndrome Scale (PANSS) Baseline, then every 4 weeks up to 26 weeks
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
"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 Every 2 weeks up to 26 weeks
Movement disorders (Abnormal Involuntary Movement Scale [AIMS]) Baseline, and after 12 and 26 weeks
Weight change Baseline, and after 12 and 26 weeks
Enrollment 21
Condition
Intervention

Intervention Type: Drug

Intervention Name: Olanzapine

Intervention Type: Drug

Intervention Name: Amisulpride

Intervention Type: Drug

Intervention Name: Risperidone

Intervention Type: Drug

Intervention Name: Haloperidol

Intervention Type: Drug

Intervention Name: Quetiapine

Intervention Type: Drug

Intervention Name: Perphenazine

Intervention Type: Drug

Intervention Name: Sulpiride

Intervention Type: Drug

Intervention Name: bromperidol

Intervention Type: Drug

Intervention Name: Zuclopenthixol

Intervention Type: Drug

Intervention Name: Thioridazine

Intervention Type: Drug

Intervention Name: Paliperidone

Intervention Type: Drug

Intervention Name: Ziprasidone

Intervention Type: Drug

Intervention Name: Benperidol

Intervention Type: Drug

Intervention Name: Fluspirilene

Intervention Type: Drug

Intervention Name: Pimozide

Intervention Type: Drug

Intervention Name: Perazine

Intervention Type: Drug

Intervention Name: Fluphenazine

Intervention Type: Drug

Intervention Name: Flupentixole

Intervention Type: Drug

Intervention Name: Sertindole

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Location
Facility: Psychiatrische Klinik und Poliklinik fuer Psychiatrie und Psychotherapie der Technischen Universitaet Muenchen am Klinikum rechts der Isar
Location Countries

Germany

Verification Date

October 2018

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Intervention

Type: Experimental

Description: Intervention group: guided discontinuation or dose-reduction of the current antipsychotic medication. The antipsychotic drug used before study start will be discontinued gradually under medical surveillance. The process of discontinuation depends on the physicians judgement und should be guided be the participants needs and clinical status. This approach was already used before in another study ("gradual discontinuation", Wunderink et al., 2007). We assume that the dose can be reduced by approximately 1/6 of the starting dose every two weeks. If long acting antipsychotics are applied, there is no need for a gradual discontinuation due to their long half life.

Label: Control

Type: Active Comparator

Description: The participants receive the same antipsychotic drugs, they have received before the start of the study, without changing the dose or the application form. Study medication is, with exception of Clozapin, every oral or depot neuroleptic drug approved for the treatment of schizophrenia in Germany.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov