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

Technical University of Munich

Status and phase

Completed

Phase 4

Conditions

Schizoaffective Disorders

Schizophrenia

Schizophrenia and Disorders With Psychotic Features

Treatments

Drug: Haloperidol

Drug: Pimozide

Drug: Fluphenazine

Drug: Zuclopenthixol

Drug: Ziprasidone

Drug: bromperidol

Drug: Sulpiride

Drug: Perphenazine

Drug: Olanzapine

Drug: Paliperidone

Drug: Benperidol

Drug: Fluspirilene

Drug: Perazine

Drug: Thioridazine

Drug: Sertindole

Drug: Amisulpride

Drug: Flupentixole

Drug: Risperidone

Drug: Quetiapine

Study type

Interventional

Funder types

Other

Identifiers

NCT02307396

DO 1723/1-1 (Other Grant/Funding Number)

2013-000338-37 (EudraCT Number)

DRKS00006878 (Other Identifier)

1723/1-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

21 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

21 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Drug: Ziprasidone

Drug: Pimozide

Drug: Benperidol

Drug: Sulpiride

Drug: Fluspirilene

Drug: Sertindole

Drug: Perphenazine

Drug: Flupentixole

Drug: Thioridazine

Drug: Olanzapine

Drug: Fluphenazine

Drug: bromperidol

Drug: Haloperidol

Drug: Zuclopenthixol

Drug: Quetiapine

Drug: Risperidone

Drug: Perazine

Drug: Paliperidone

Drug: Amisulpride

Control

Active Comparator group

Description:

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.

Treatment:

Drug: Ziprasidone

Drug: Pimozide

Drug: Benperidol

Drug: Sulpiride

Drug: Fluspirilene

Drug: Sertindole

Drug: Perphenazine

Drug: Flupentixole

Drug: Thioridazine

Drug: Olanzapine

Drug: Fluphenazine