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

Technical University of Munich

Status: Completed

Conditions: Schizophreniform Disorder; Schizophrenia; Schizoaffective Disorder

Treatments: Drug: Olanzapine or amisulpride

Study type: Interventional

Funder types: Other

Identifiers

NCT01029769

01KG0910

Details and patient eligibility

About

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

Full 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

Enrollment: 350 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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350 participants in 5 patient groups

initial olanzapine

Active Comparator group

Treatment:

Drug: Olanzapine or amisulpride

initial amisulpride

Active Comparator group

Treatment:

Drug: Olanzapine or amisulpride

early responders

Active Comparator group

Treatment:

Drug: Olanzapine or amisulpride

early non-responders switched

Active Comparator group

Treatment:

Drug: Olanzapine or amisulpride

ealy non-responders non-switched

Active Comparator group

Treatment:

Drug: Olanzapine or amisulpride