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Completed

NCT Number: NCT02307396

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Munich, Bavaria, 81675, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Primary outcomes

  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:

    • 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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 4, 2014
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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