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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02307396
• Other study ID #: 1723/1-1
• Secondary ID: 2013-000338-37DO
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2015
• Est. completion date: June 22, 2016

Study information

• Verified date: October 2018
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 22, 2016
• Est. primary completion date: June 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Psychotic Disorders
• Schizoaffective Disorders
• Schizophrenia
• Schizophrenia and Disorders With Psychotic Features
• Schizophrenia Spectrum and Other Psychotic Disorders

Intervention

Drug:
• Olanzapine

• Amisulpride

• Risperidone

• Haloperidol

• Quetiapine

• Perphenazine

• Sulpiride

• bromperidol

• Zuclopenthixol

• Thioridazine

• Paliperidone

• Ziprasidone

• Benperidol

• Fluspirilene

• Pimozide

• Perazine

• Fluphenazine

• Flupentixole

• Sertindole

Locations

Country	Name	City	State
Germany	Psychiatrische Klinik und Poliklinik fuer Psychiatrie und Psychotherapie der Technischen Universitaet Muenchen am Klinikum rechts der Isar	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse	The criterion is measured at every visit (every two weeks) two weeks with two criteria, both have to be fullfilled: 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); Score =4 on the "Clinical Global Impression Severity Scale" (CGI-S; Guy, 1976b)	Every 2 weeks up to 26 weeks
Secondary	Psychiatric rehospitalisation		Every 2 weeks up to 26 weeks
Secondary	Totalscore of Positive and Negative Syndrome Scale (PANSS)	PANSS-Scale	Baseline, then every 4 weeks up to 26 weeks
Secondary	Occurence of specific adverse effects (open interview)		Baseline,then every 4 weeks up to 26 weeks
Secondary	Clinical Global Impression - Severity Scale (CGI-S)	CGI-I Scale	Baseline, then every 4 weeks up to 26 weeks
Secondary	"Quality of life" measured by the questionnaire "Subjective well-being under neuroleptics scale" (SW-N)	SW-N-Scale	Baseline, and after 12 and 26 weeks
Secondary	Status of occupation		Baseline, and after 12 and 26 weeks
Secondary	Personal and Social Performance (Personal and Social Performance Scale [PSP])	PSP-Scale	Baseline, and after 12 and 26 weeks
Secondary	Adherence/Attitude of patients towards medication (Medication Adherence Rating Scale [MARS])	MARS-Scale	Baseline, and after 12 and 26 weeks
Secondary	Drop-outs total and due to specific reasons		Every 2 weeks up to 26 weeks
Secondary	Movement disorders (Abnormal Involuntary Movement Scale [AIMS])	AIMS-Scale	Baseline, and after 12 and 26 weeks
Secondary	Weight change		Baseline, and after 12 and 26 weeks