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

Sponsor

Technische Universität München (Other)

Overall Status

Completed

CT.gov ID

NCT01029769

Collaborator

(none)

351

Enrollment

Location

Arms

62.9

Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Schizoaffective Disorder Schizophreniform Disorder	Drug: Olanzapine or amisulpride	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

351 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, 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

Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Number of patients in remission at week 8 comparing the "switched" with the "non switched" early non-responders) [8 weeks]

Secondary Outcome Measures

PANSS total score change [8 weeks]
Cost of care [8 weeks]
Safety: Simpson-Angus Scale, Barnes Akathisia Scale, open interviews [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Psychiatrische Klinik und Poliklinik fuer Psychiatrie und Psychotherapie der Technischen Universitaet Muenchen am Klinikum rechts der Isar	Munic	Bavaria	Germany	81675

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