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

Sponsor

Technische Universität München (Other)

Overall Status

Completed

CT.gov ID

NCT02307396

Collaborator

(none)

Enrollment

Location

Arms

16.7

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Schizophrenia and Disorders With Psychotic Features Schizoaffective Disorders	Drug: 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	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Jun 22, 2016

Actual Study Completion Date :

Jun 22, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention 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.	Drug: 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
Active Comparator: Control 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.	Drug: 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

Arm

Intervention/Treatment

Experimental: Intervention

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.

Drug: 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

Active Comparator: Control

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.

Drug: 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

Outcome Measures

Primary Outcome Measures

Relapse [Every 2 weeks up to 26 weeks]
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)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Psychiatrische Klinik und Poliklinik fuer Psychiatrie und Psychotherapie der Technischen Universitaet Muenchen am Klinikum rechts der Isar	Munich	Bavaria	Germany	81675