The Switch Study - Efficacy of an Early Antipsychotic Switch in Case of Poor Initial Response to the Treatment of Schizophrenia
This study is currently recruiting participants.
Verified January 2013 by Technische Universität München
Sponsor:
Technische Universität München
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01029769
First received: December 9, 2009
Last updated: January 22, 2013
Last verified: January 2013
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Purpose
The main aim of the trial is to study whether a change of medication in non-responders to a two-weeks antipsychotic drug trial is more effective than continued treatment with the same antipsychotic. Hypothesis: Non-responders who are switched at 2 weeks to another antipsychotic are more frequently in symptomatic remission at week 8 than non-responders who stay on the same antipsychotic
| Condition | Intervention |
|---|---|
|
Schizophrenia Schizoaffective Disorder Schizophreniform Disorder |
Drug: Olanzapine or amisulpride |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Switch Study - Efficacy of Early Antipsychotic Switch Versus Maintenance in Patients With Schizophrenia Poorly Responding to Two Weeks of Antipsychotic Treatment |
Resource links provided by NLM:
Further study details as provided by Technische Universität München:
Primary Outcome Measures:
- Number of patients in remission at week 8 comparing the "switched" with the "non switched" early non-responders) [ Time Frame: 8 weeks ]
Secondary Outcome Measures:
- PANSS total score change [ Time Frame: 8 weeks ]
- Cost of care [ Time Frame: 8 weeks ]
- Safety: Simpson-Angus Scale, Barnes Akathisia Scale, open interviews [ Time Frame: 8 weeks ]
| Estimated Enrollment: | 350 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: initial olanzapin |
Drug: Olanzapine or amisulpride
Oral olanzapine 5mg to 20mg/d OR oral amisulpride 200mg to 800mg/d; both preferably once daily, both encapsulated for blinding
|
| Active Comparator: initial amisulpride |
Drug: Olanzapine or amisulpride
Oral olanzapine 5mg to 20mg/d OR oral amisulpride 200mg to 800mg/d; both preferably once daily, both encapsulated for blinding
|
| Active Comparator: early responders |
Drug: Olanzapine or amisulpride
Oral olanzapine 5mg to 20mg/d OR oral amisulpride 200mg to 800mg/d; both preferably once daily, both encapsulated for blinding
|
| Active Comparator: early non-responders switched |
Drug: Olanzapine or amisulpride
Oral olanzapine 5mg to 20mg/d OR oral amisulpride 200mg to 800mg/d; both preferably once daily, both encapsulated for blinding
|
| Active Comparator: ealy non-responders non-switched |
Drug: Olanzapine or amisulpride
Oral olanzapine 5mg to 20mg/d OR oral amisulpride 200mg to 800mg/d; both preferably once daily, both encapsulated for blinding
|
Detailed Description:
The patients will be randomised to a double-blind 2 week run in phase with fixed doses of either oral amisulpride 800 mg/day or olanzapine 20mg/day.
Those participants who have not responded to treatment at two weeks (PANSS improvement <25%) will be randomised to a 6 week double blind flexible dose phase:
- Experimental intervention: switch to the other antipsychotic (oral olanzapine 5-20mg/d or oral amisulpride 200-800 mg/d)
- Control intervention: continuation with the same drug as in the first 2 weeks in flexible dose ranges as above for another six weeks Those participants who have responded at week 2 (≥25% PANSS reduction) will continue on the same drug in flexible dose ranges as above Total duration of intervention per patient: 8 weeks
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Inpatients with DSM-IV TR diagnosis of schizophrenia, schizophreniform or schizoaffective disorder
- PANSS total score at baseline > 75, at least two PANSS psychosis items ≥ 4, Clinical Global Impression of severity score moderately ill or more (≥4)
- Increase in the level of care (outpatient care to day clinic or inpatient care)
Exclusion Criteria:
- contraindication to study drugs
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029769
Contacts
| Contact: Stefan Leucht, MD | 0049(0)894140 ext 4249 | Stefan.leucht@lrz.tum.de |
Locations
| Germany | |
| Psychiatrische Klinik und Poliklinik fuer Psychiatrie und Psychotherapie der Technischen Universitaet Muenchen am Klinikum rechts der Isar | Recruiting |
| Munic, Bavaria, Germany, 81675 | |
| Contact: Stephan Heres, MD 0049(0)894140 ext 4227 s.heres@lrz.tum.de | |
| Contact: Stefan Leucht, MD 0049(0)894140 ext 4249 Stefan.leucht@lrz.tum.de | |
| Principal Investigator: Stefan Leucht, MD | |
| Sub-Investigator: Stephan Heres, MD | |
Sponsors and Collaborators
Technische Universität München
Investigators
| Principal Investigator: | Stefan Leucht, MD | Psychiatrische Klinik und Poliklinik fuer Psychiatrie und Psychotherapie der Technischen Universität München am Klinikum rechts der Isar |
More Information
No publications provided
| Responsible Party: | Technische Universität München |
| ClinicalTrials.gov Identifier: | NCT01029769 History of Changes |
| Other Study ID Numbers: | 01KG0910 |
| Study First Received: | December 9, 2009 |
| Last Updated: | January 22, 2013 |
| Health Authority: | Germany: Federal Ministry of Education and Research |
Additional relevant MeSH terms:
|
Psychotic Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Antipsychotic Agents Sultopride Olanzapine Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Psychotropic Drugs Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on June 18, 2013