Trial document

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DRKS-ID: DRKS00006878

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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 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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Brief Summary in Scientific Language

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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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

DRKS-ID: DRKS00006878
Date of Registration in DRKS: 2014/11/06
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 353/14, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München

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Secondary IDs

EudraCT-No. (for studies acc. to Drug Law): 2013-000338-37

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Health Condition or Problem studied

ICD10: F20 - Schizophrenia
ICD10: F25 - Schizoaffective disorders

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Interventions/Observational Groups

Arm 1: 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. After randomisation (start of the active study phase) no further depot medication will be applied. Study medication is, with exception of Clozapin, every oral or depot neuroleptic drug approved for the treatment of schizophrenia in Germany.
Arm 2: Control group: The participants must be stable. They will 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.

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Blinded
Who is blinded: assessor, data analyst
Control: Active control
Purpose: Treatment
Assignment: Parallel
Phase: IV
Off-label Drug use: No

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Primary Outcome

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

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Secondary Outcome

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

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Countries of Recruitment

DE: Germany

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Locations of Recruitment

University Medical Center Klinik für Psychiatrie des Klinikums rechts der Isar, München

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Recruitment

Planned/Actual: Planned
(Anticipated or Actual) Date of First Enrollment: 2014/12/01
Target Sample Size: 25
Monocenter/Multicenter trial: Monocenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: 65 Years

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Additional Inclusion Criteria

- Male or female patients, 18 to 65 years of age.
- 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, 1976b)
- Able to give informed consent.

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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.

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Addresses

Primary Sponsor
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- Klinikum rechts der Isar der TU München
- Ismaninger Str. 22
- 81675 München
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.med.tu-muenchen.de
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Contact for Scientific Queries
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- Klinik für Psychiatrie und PsychotherapieTechnische Universität MünchenKlinikum rechts der Isar
- Mr. Prof. Dr. Stefan Leucht
- Ismaninger Str. 22
- 81675 München
- Germany
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- Telephone: 0049 89 4140 6415
- Fax: [---]*
- E-mail: stefan.leucht at lrz.tum.de
- URL: [---]*
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Contact for Public Queries
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- Klinik für Psychiatrie und PsychotherapieTechnische Universität MünchenKlinikum rechts der Isar
- Mr. Prof. Dr. Stefan Leucht
- Ismaninger Str. 22
- 81675 München
- Germany
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- Telephone: 0049 89 4140 6415
- Fax: [---]*
- E-mail: stefan.leucht at lrz.tum.de
- URL: [---]*
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Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
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- Deutsche Forschungsgemeinschaft
- Kennedyallee 40
- 53175 Bonn
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.dfg.de
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Status

Recruitment Status: Recruiting planned
Study Closing (LPLV): [---]*

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Trial Publications, Results and other Documents

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