Clinical trial NCT02307396: Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics in Schizophrenic Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizophrenia and Disorders With Psychotic Features
Schizoaffective Disorders
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2014-12-04
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Relapse
timeFrame: Every 2 weeks up to 26 weeks
Secondary outcomes:
measure: Psychiatric rehospitalisation
timeFrame: Every 2 weeks up to 26 weeks
measure: Totalscore of Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline, then every 4 weeks up to 26 weeks
measure: Occurence of specific adverse effects (open interview)
timeFrame: Baseline,then every 4 weeks up to 26 weeks
measure: Clinical Global Impression - Severity Scale (CGI-S)
timeFrame: Baseline, then every 4 weeks up to 26 weeks
measure: "Quality of life" measured by the questionnaire "Subjective well-being under neuroleptics scale" (SW-N)
timeFrame: Baseline, and after 12 and 26 weeks
measure: Status of occupation
timeFrame: Baseline, and after 12 and 26 weeks
measure: Personal and Social Performance (Personal and Social Performance Scale [PSP])
timeFrame: Baseline, and after 12 and 26 weeks
measure: Adherence/Attitude of patients towards medication (Medication Adherence Rating Scale [MARS])
timeFrame: Baseline, and after 12 and 26 weeks
measure: Drop-outs total and due to specific reasons
timeFrame: Every 2 weeks up to 26 weeks
measure: Movement disorders (Abnormal Involuntary Movement Scale [AIMS])
timeFrame: Baseline, and after 12 and 26 weeks
measure: Weight change
timeFrame: Baseline, and after 12 and 26 weeks
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Psychiatrische Klinik und Poliklinik fuer Psychiatrie und Psychotherapie der Technischen Universitaet Muenchen am Klinikum rechts der Isar
state: Bavaria
Study officials:
affiliation: Klinikum rechts der Isar
name: Stefan Leucht, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum rechts der Isar
name: Markus Dold, MD
role: PRINCIPAL_INVESTIGATOR
References: