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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. (see Contacts and Locations)
Verified January 2014 by Technische Universität München
Sponsor:
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01029769
First received: December 9, 2009
Last updated: January 10, 2014
Last verified: January 2014

December 9, 2009
January 10, 2014
December 2009
July 2014   (final data collection date for primary outcome measure)
Number of patients in remission at week 8 comparing the "switched" with the "non switched" early non-responders) [ Time Frame: 8 weeks ]
Same as current
Complete list of historical versions of study NCT01029769 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Switch Study - Efficacy of an Early Antipsychotic Switch in Case of Poor Initial Response to the Treatment of Schizophrenia
The Switch Study - Efficacy of Early Antipsychotic Switch Versus Maintenance in Patients With Schizophrenia Poorly Responding to Two Weeks of Antipsychotic Treatment

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

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorder
  • Schizophreniform Disorder
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 olanzapin
    Intervention: Drug: Olanzapine or amisulpride
  • Active Comparator: initial amisulpride
    Intervention: Drug: Olanzapine or amisulpride
  • Active Comparator: early responders
    Intervention: Drug: Olanzapine or amisulpride
  • Active Comparator: early non-responders switched
    Intervention: Drug: Olanzapine or amisulpride
  • Active Comparator: ealy non-responders non-switched
    Intervention: Drug: Olanzapine or amisulpride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
350
December 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Stefan Leucht, MD 0049(0)894140 ext 4249 Stefan.leucht@lrz.tum.de
Germany
 
NCT01029769
01KG0910
Yes
Technische Universität München
Technische Universität München
Not Provided
Principal Investigator: Stefan Leucht, MD Psychiatrische Klinik und Poliklinik fuer Psychiatrie und Psychotherapie der Technischen Universität München am Klinikum rechts der Isar
Technische Universität München
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP