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
  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 2014
Estimated Primary Completion Date: July 2014 (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:

  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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 10, 2014
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
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on August 01, 2014