Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics in Schizophrenic Patients
Information source: Technische Universität München
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
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
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.
Clinical Details
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 rehospitalisationTotalscore 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.
Eligibility
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
Locations and Contacts
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
Additional Information
Starting date: November 2014
Last updated: December 1, 2014
|