The Switch Study - Efficacy of Early Antipsychotic Switch Versus Maintenance in Patients With Schizophrenia Poorly Responding to Two Weeks of Antipsychotic Treatment
Overview
- Phase
- Not Applicable
- Intervention
- Olanzapine or amisulpride
- Conditions
- Schizophrenia
- Sponsor
- Technical University of Munich
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Number of Patients in Symptomatic Remission at Week 8 Comparing the "Switched" With the "Non Switched" Early Non-responders
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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
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: 1. Experimental intervention: switch to the other antipsychotic (oral olanzapine 5-20mg/d or oral amisulpride 200-800 mg/d) 2. 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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inpatients with Diagnostic and Statistical Manual of Mental Disorders 4th Edition Text Revision (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
Arms & Interventions
initial olanzapine
Intervention: Olanzapine or amisulpride
initial amisulpride
Intervention: Olanzapine or amisulpride
early responders
Intervention: Olanzapine or amisulpride
early non-responders switched
Intervention: Olanzapine or amisulpride
ealy non-responders non-switched
Intervention: Olanzapine or amisulpride
Outcomes
Primary Outcomes
Number of Patients in Symptomatic Remission at Week 8 Comparing the "Switched" With the "Non Switched" Early Non-responders
Time Frame: 8 weeks
Remission is defined as a maximum rating of 3 points (equals a severity rating of "mild") in each of all the following eight items of the PANSS (Kay et al.) rating scale: Delusions (P1), unusual thought content (G9), hallucinatory behavior (P3), conceptual disorganization (P2), mannerisms/posturing (G5), blunted affect (N1), social withdrawal (N4) and lack of spontaneity (N6); if one item is \>3 the remission status is "no" (non-remission); all times have a rating from 1 to 7, so the min. rating is 8, the max. rating is 56. Remission is a dichotomous item (yes/no) without a specific min. or max. rating
Secondary Outcomes
- PANSS Total Score Change(8 weeks)