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Trial record 9 of 12 for:    pimozide

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

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ClinicalTrials.gov Identifier: NCT02307396
Recruitment Status : Completed
First Posted : December 4, 2014
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Technische Universität München

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.

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Study Type : Interventional  (Clinical Trial)
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 : February 1, 2015
Actual Primary Completion Date : June 22, 2016
Actual Study Completion Date : June 22, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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



Primary Outcome Measures :
  1. Relapse [ Time Frame: 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:

    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)


Secondary Outcome Measures :
  1. Psychiatric rehospitalisation [ Time Frame: Every 2 weeks up to 26 weeks ]
  2. Totalscore of Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline, then every 4 weeks up to 26 weeks ]
    PANSS-Scale

  3. Occurence of specific adverse effects (open interview) [ Time Frame: Baseline,then every 4 weeks up to 26 weeks ]
  4. Clinical Global Impression - Severity Scale (CGI-S) [ Time Frame: Baseline, then every 4 weeks up to 26 weeks ]
    CGI-I Scale

  5. "Quality of life" measured by the questionnaire "Subjective well-being under neuroleptics scale" (SW-N) [ Time Frame: Baseline, and after 12 and 26 weeks ]
    SW-N-Scale

  6. Status of occupation [ Time Frame: Baseline, and after 12 and 26 weeks ]
  7. Personal and Social Performance (Personal and Social Performance Scale [PSP]) [ Time Frame: Baseline, and after 12 and 26 weeks ]
    PSP-Scale

  8. Adherence/Attitude of patients towards medication (Medication Adherence Rating Scale [MARS]) [ Time Frame: Baseline, and after 12 and 26 weeks ]
    MARS-Scale

  9. Drop-outs total and due to specific reasons [ Time Frame: Every 2 weeks up to 26 weeks ]
  10. Movement disorders (Abnormal Involuntary Movement Scale [AIMS]) [ Time Frame: Baseline, and after 12 and 26 weeks ]
    AIMS-Scale

  11. Weight change [ Time Frame: Baseline, and after 12 and 26 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02307396


Locations
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Germany
Psychiatrische Klinik und Poliklinik fuer Psychiatrie und Psychotherapie der Technischen Universitaet Muenchen am Klinikum rechts der Isar
Munich, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Investigators
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Principal Investigator: Stefan Leucht, Professor Klinikum rechts der Isar
Principal Investigator: Markus Dold, MD Klinikum rechts der Isar

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Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT02307396     History of Changes
Other Study ID Numbers: 1723/1-1
2013-000338-37 ( EudraCT Number )
DO 1723/1-1 ( Other Grant/Funding Number: DFG (Deutsche Forschungs Gesellschaft) )
DRKS00006878 ( Other Identifier: Deutsches Register Klinischer Studien )
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Pimozide
Disease
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Pathologic Processes
Mental Disorders
Haloperidol
Olanzapine
Risperidone
Antipsychotic Agents
Quetiapine Fumarate
Paliperidone Palmitate
Ziprasidone
Amisulpride
Sertindole
Perphenazine
Fluphenazine
Sulpiride
Thioridazine
Clopenthixol
Fluspirilene
Benperidol
Perazine
Bromperidol
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs