Overview

This trial is active, not recruiting.

Conditions schizophrenia, schizophrenia and disorders with psychotic features, schizoaffective disorders
Treatments olanzapine, amisulpride, risperidone, haloperidol, quetiapine, perphenazine, sulpiride, bromperidol, zuclopenthixol, thioridazine, paliperidone, ziprasidone, benperidol, fluspirilene, pimozide, perazine, fluphenazine, flupentixole, sertindole
Phase phase 4
Sponsor Technische Universität München
Start date November 2014
End date May 2016
Trial size 25 participants
Trial identifier NCT02307396, 1723/1-1, 2013-000338-37, DO 1723/1-1, DRKS00006878

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
olanzapine
amisulpride
risperidone
haloperidol
quetiapine
perphenazine
sulpiride
bromperidol
zuclopenthixol
thioridazine
paliperidone
ziprasidone
benperidol
fluspirilene
pimozide
perazine
fluphenazine
flupentixole
sertindole
(Active Comparator)
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.
olanzapine
amisulpride
risperidone
haloperidol
quetiapine
perphenazine
sulpiride
bromperidol
zuclopenthixol
thioridazine
paliperidone
ziprasidone
benperidol
fluspirilene
pimozide
perazine
fluphenazine
flupentixole
sertindole

Primary Outcomes

Measure
Relapse
time frame: Every 2 weeks up to 26 weeks

Secondary Outcomes

Measure
Psychiatric rehospitalisation
time frame: Every 2 weeks up to 26 weeks
Totalscore of Positive and Negative Syndrome Scale (PANSS)
time frame: Baseline, then every 4 weeks up to 26 weeks
Occurence of specific adverse effects (open interview)
time frame: Baseline,then every 4 weeks up to 26 weeks
Clinical Global Impression - Severity Scale (CGI-S)
time frame: Baseline, then every 4 weeks up to 26 weeks
"Quality of life" measured by the questionnaire "Subjective well-being under neuroleptics scale" (SW-N)
time frame: Baseline, and after 12 and 26 weeks
Status of occupation
time frame: Baseline, and after 12 and 26 weeks
Personal and Social Performance (Personal and Social Performance Scale [PSP])
time frame: Baseline, and after 12 and 26 weeks
Adherence/Attitude of patients towards medication (Medication Adherence Rating Scale [MARS])
time frame: Baseline, and after 12 and 26 weeks
Drop-outs total and due to specific reasons
time frame: Every 2 weeks up to 26 weeks
Movement disorders (Abnormal Involuntary Movement Scale [AIMS])
time frame: Baseline, and after 12 and 26 weeks
Weight change
time frame: Baseline, and after 12 and 26 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

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
Principal investigator Stefan Leucht, Professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Technische Universität München.