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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000338-37 | EudraCT Number | ||
| DO 1723/1-1 | Other Grant/Funding Number | DFG (Deutsche Forschungs Gesellschaft) | |
| DRKS00006878 | Other Identifier | Deutsches Register Klinischer Studien |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olanzapine | Drug |
| ||
| Amisulpride |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse | The criterion is measured at every visit (every two weeks) two weeks with two criteria, both have to be fullfilled:
| Every 2 weeks up to 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Psychiatric rehospitalisation | Every 2 weeks up to 26 weeks | |
| Totalscore of Positive and Negative Syndrome Scale (PANSS) | PANSS-Scale | Baseline, then every 4 weeks up to 26 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Leucht, Professor | Klinikum rechts der Isar | Principal Investigator |
| Markus Dold, MD | Klinikum rechts der Isar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatrische Klinik und Poliklinik fuer Psychiatrie und Psychotherapie der Technischen Universitaet Muenchen am Klinikum rechts der Isar | Munich | Bavaria | 81675 | Germany |
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|
| 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 |
|
| Occurence of specific adverse effects (open interview) | Baseline,then every 4 weeks up to 26 weeks |
| Clinical Global Impression - Severity Scale (CGI-S) | CGI-I Scale | Baseline, then every 4 weeks up to 26 weeks |
| "Quality of life" measured by the questionnaire "Subjective well-being under neuroleptics scale" (SW-N) | SW-N-Scale | 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]) | PSP-Scale | Baseline, and after 12 and 26 weeks |
| Adherence/Attitude of patients towards medication (Medication Adherence Rating Scale [MARS]) | MARS-Scale | Baseline, and after 12 and 26 weeks |
| Drop-outs total and due to specific reasons | Every 2 weeks up to 26 weeks |
| Movement disorders (Abnormal Involuntary Movement Scale [AIMS]) | AIMS-Scale | Baseline, and after 12 and 26 weeks |
| Weight change | Baseline, and after 12 and 26 weeks |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| D000077582 | Amisulpride |
| D018967 | Risperidone |
| D006220 | Haloperidol |
| D000069348 | Quetiapine Fumarate |
| D010546 | Perphenazine |
| D013469 | Sulpiride |
| C006820 | bromperidol |
| D003006 | Clopenthixol |
| D013881 | Thioridazine |
| D000068882 | Paliperidone Palmitate |
| C092292 | ziprasidone |
| D001544 | Benperidol |
| D005484 | Fluspirilene |
| D010868 | Pimozide |
| D010464 | Perazine |
| D005476 | Fluphenazine |
| C066304 | sertindole |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D010640 | Phenothiazines |
| D013892 | Thioxanthenes |
| D014966 | Xanthenes |
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D013141 | Spiro Compounds |
| D007093 | Imidazoles |
| D010880 | Piperidines |
| D011083 | Polycyclic Compounds |
| D001562 | Benzimidazoles |
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