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

NCT02307396 | Completed Phase 4 DMC

• 4 other identifiers: 1723/1-12013-000338-37DO 1723/1-1DRKS00006878
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizophrenia and Disorders With Psychotic Features; Schizoaffective Disorders

Outcome Measures

Primary Outcomes (1)

• Relapse

  The criterion is measured at every visit (every two weeks) two weeks with two criteria, both have to be fullfilled: 1. 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) 2. Score ≥4 on the "Clinical Global Impression Severity Scale" (CGI-S; Guy, 1976b)

  Every 2 weeks up to 26 weeks

Secondary Outcomes (11)

• 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

• 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

• "Quality of life" measured by the questionnaire "Subjective well-being under neuroleptics scale" (SW-N)

  Baseline, and after 12 and 26 weeks

Study Arms (2)

Intervention

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.

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

Control

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.

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

Interventions

Olanzapine DRUG

Control; Intervention

Amisulpride DRUG

Control; Intervention

Risperidone DRUG

Control; Intervention

Haloperidol DRUG

Control; Intervention

Quetiapine DRUG

Control; Intervention

Perphenazine DRUG

Control; Intervention

Sulpiride DRUG

Control; Intervention

bromperidol DRUG

Control; Intervention

Zuclopenthixol DRUG

Control; Intervention

Thioridazine DRUG

Control; Intervention

Paliperidone DRUG

Control; Intervention

Ziprasidone DRUG

Control; Intervention

Benperidol DRUG

Control; Intervention

Fluspirilene DRUG

Control; Intervention

Pimozide DRUG

Control; Intervention

Perazine DRUG

Control; Intervention

Fluphenazine DRUG

Control; Intervention

Flupentixole DRUG

Control; Intervention

Sertindole DRUG

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Psychiatrische Klinik und Poliklinik fuer Psychiatrie und Psychotherapie der Technischen Universitaet Muenchen am Klinikum rechts der Isar

Munich, Bavaria, 81675, Germany

Location

MeSH Terms

Conditions

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders

Interventions

Olanzapine; Amisulpride; Risperidone; Haloperidol; Quetiapine Fumarate; Perphenazine; Sulpiride; bromperidol; Clopenthixol; Thioridazine; Paliperidone Palmitate; ziprasidone; Benperidol; Fluspirilene; Pimozide; Perazine; Fluphenazine; sertindole

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Butyrophenones; Ketones; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Heterocyclic Compounds, 3-Ring; Phenothiazines; Thioxanthenes; Xanthenes; Isoxazoles; Azoles; Spiro Compounds; Imidazoles; Piperidines; Polycyclic Compounds; Benzimidazoles

Study Officials

• Stefan Leucht, Professor

  Klinikum rechts der Isar

  PRINCIPAL INVESTIGATOR

• Markus Dold, MD

  Klinikum rechts der Isar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: December 4, 2014
• Study Start: February 1, 2015
• Primary Completion: June 22, 2016
• Study Completion: June 22, 2016
• Last Updated: October 11, 2018

Record last verified: 2018-10

Locations

DE (1)