Efficacy of an Early Antipsychotic Switch in Case of Poor Initial Response to the Treatment of Schizophrenia

Schizophrenia Clinical Trial

Official title:

The Switch Study - Efficacy of Early Antipsychotic Switch Versus Maintenance in Patients With Schizophrenia Poorly Responding to Two Weeks of Antipsychotic Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01029769
• Other study ID #: 01KG0910
• Status: Completed
• Phase: N/A
• First received: December 9, 2009
• Last updated: May 22, 2015
• Start date: December 2009
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: March 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophreniform Disorder

Intervention

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

Locations

Country	Name	City	State
Germany	Psychiatrische Klinik und Poliklinik fuer Psychiatrie und Psychotherapie der Technischen Universitaet Muenchen am Klinikum rechts der Isar	Munic	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients in remission at week 8 comparing the "switched" with the "non switched" early non-responders)		8 weeks	No
Secondary	PANSS total score change		8 weeks	No
Secondary	Cost of care		8 weeks	No
Secondary	Safety: Simpson-Angus Scale, Barnes Akathisia Scale, open interviews		8 weeks	Yes