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

Condition(s) targeted: Schizophrenia; Schizophrenia and Disorders With Psychotic Features; Schizoaffective Disorders

Intervention: Olanzapine (Drug); Amisulpride (Drug); Risperidone (Drug); Haloperidol (Drug); Quetiapine (Drug); Perphenazine (Drug); Sulpiride (Drug); bromperidol (Drug); Zuclopenthixol (Drug); Thioridazine (Drug); Paliperidone (Drug); Ziprasidone (Drug); Benperidol (Drug); Fluspirilene (Drug); Pimozide (Drug); Perazine (Drug); Fluphenazine (Drug); Flupentixole (Drug); Sertindole (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Technische Universität München

Official(s) and/or principal investigator(s):
Stefan Leucht, Professor, Principal Investigator, Affiliation: Klinikum rechts der Isar
Markus Dold, MD, Principal Investigator, Affiliation: Klinikum rechts der Isar

Overall contact:
Stefan Leucht, Professor, Phone: +49 89 4140, Ext: 4249, Email: stefan.leucht@lrz.tum.de

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Relapse

Secondary outcome:

Psychiatric rehospitalisation

Totalscore of Positive and Negative Syndrome Scale (PANSS)

Occurence of specific adverse effects (open interview)

Clinical Global Impression - Severity Scale (CGI-S)

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

Status of occupation

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

Adherence/Attitude of patients towards medication (Medication Adherence Rating Scale [MARS])

Drop-outs total and due to specific reasons

Movement disorders (Abnormal Involuntary Movement Scale [AIMS])

Weight change

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Stefan Leucht, Professor, Phone: +49 89 4140, Ext: 4249, Email: stefan.leucht@lrz.tum.de

Psychiatrische Klinik und Poliklinik fuer Psychiatrie und Psychotherapie der Technischen Universitaet Muenchen am Klinikum rechts der Isar, Munich, Bavaria 81675, Germany; Recruiting
Stefan Leucht, MD, Phone: 0049(0)894140, Ext: 4249, Email: Stefan.leucht@lrz.tum.de
Maximilian Huhn, MD, Phone: 0049(0)894140, Ext: 6466, Email: maximilian.huhn@lrz.tum.de
Stefan Leucht, Professor, Principal Investigator
Stephan Heres, MD, Sub-Investigator
Markus Dold, MD, Principal Investigator
Maximilian Huhn, MD, Sub-Investigator

Starting date: November 2014
Last updated: December 1, 2014