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

Primary Purpose

Schizophrenia, Schizophrenia and Disorders With Psychotic Features, Schizoaffective Disorders

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Olanzapine
Amisulpride
Risperidone
Haloperidol
Quetiapine
Perphenazine
Sulpiride
bromperidol
Zuclopenthixol
Thioridazine
Paliperidone
Ziprasidone
Benperidol
Fluspirilene
Pimozide
Perazine
Fluphenazine
Flupentixole
Sertindole
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

Relapse
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 Outcome Measures

Psychiatric rehospitalisation
Totalscore of Positive and Negative Syndrome Scale (PANSS)
PANSS-Scale
Occurence of specific adverse effects (open interview)
Clinical Global Impression - Severity Scale (CGI-S)
CGI-I Scale
"Quality of life" measured by the questionnaire "Subjective well-being under neuroleptics scale" (SW-N)
SW-N-Scale
Status of occupation
Personal and Social Performance (Personal and Social Performance Scale [PSP])
PSP-Scale
Adherence/Attitude of patients towards medication (Medication Adherence Rating Scale [MARS])
MARS-Scale
Drop-outs total and due to specific reasons
Movement disorders (Abnormal Involuntary Movement Scale [AIMS])
AIMS-Scale
Weight change

Full Information

First Posted
November 24, 2014
Last Updated
October 10, 2018
Sponsor
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT02307396
Brief Title
Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics in Schizophrenic Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2015 (Actual)
Primary Completion Date
June 22, 2016 (Actual)
Study Completion Date
June 22, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizophrenia and Disorders With Psychotic Features, Schizoaffective Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Type
Drug
Intervention Name(s)
Amisulpride
Intervention Type
Drug
Intervention Name(s)
Risperidone
Intervention Type
Drug
Intervention Name(s)
Haloperidol
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Intervention Type
Drug
Intervention Name(s)
Perphenazine
Intervention Type
Drug
Intervention Name(s)
Sulpiride
Intervention Type
Drug
Intervention Name(s)
bromperidol
Intervention Type
Drug
Intervention Name(s)
Zuclopenthixol
Intervention Type
Drug
Intervention Name(s)
Thioridazine
Intervention Type
Drug
Intervention Name(s)
Paliperidone
Intervention Type
Drug
Intervention Name(s)
Ziprasidone
Intervention Type
Drug
Intervention Name(s)
Benperidol
Intervention Type
Drug
Intervention Name(s)
Fluspirilene
Intervention Type
Drug
Intervention Name(s)
Pimozide
Intervention Type
Drug
Intervention Name(s)
Perazine
Intervention Type
Drug
Intervention Name(s)
Fluphenazine
Intervention Type
Drug
Intervention Name(s)
Flupentixole
Intervention Type
Drug
Intervention Name(s)
Sertindole
Primary Outcome Measure Information:
Title
Relapse
Description
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)
Time Frame
Every 2 weeks up to 26 weeks
Secondary Outcome Measure Information:
Title
Psychiatric rehospitalisation
Time Frame
Every 2 weeks up to 26 weeks
Title
Totalscore of Positive and Negative Syndrome Scale (PANSS)
Description
PANSS-Scale
Time Frame
Baseline, then every 4 weeks up to 26 weeks
Title
Occurence of specific adverse effects (open interview)
Time Frame
Baseline,then every 4 weeks up to 26 weeks
Title
Clinical Global Impression - Severity Scale (CGI-S)
Description
CGI-I Scale
Time Frame
Baseline, then every 4 weeks up to 26 weeks
Title
"Quality of life" measured by the questionnaire "Subjective well-being under neuroleptics scale" (SW-N)
Description
SW-N-Scale
Time Frame
Baseline, and after 12 and 26 weeks
Title
Status of occupation
Time Frame
Baseline, and after 12 and 26 weeks
Title
Personal and Social Performance (Personal and Social Performance Scale [PSP])
Description
PSP-Scale
Time Frame
Baseline, and after 12 and 26 weeks
Title
Adherence/Attitude of patients towards medication (Medication Adherence Rating Scale [MARS])
Description
MARS-Scale
Time Frame
Baseline, and after 12 and 26 weeks
Title
Drop-outs total and due to specific reasons
Time Frame
Every 2 weeks up to 26 weeks
Title
Movement disorders (Abnormal Involuntary Movement Scale [AIMS])
Description
AIMS-Scale
Time Frame
Baseline, and after 12 and 26 weeks
Title
Weight change
Time Frame
Baseline, and after 12 and 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Leucht, Professor
Organizational Affiliation
Klinikum rechts der Isar
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Markus Dold, MD
Organizational Affiliation
Klinikum rechts der Isar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatrische Klinik und Poliklinik fuer Psychiatrie und Psychotherapie der Technischen Universitaet Muenchen am Klinikum rechts der Isar
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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