Olanzapine vs. Low-dose Olanzapine Plus Trifluoperazine

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators hypothesis is that an antipsychotic drug combination of low-dose olanzapine plus low-dose trifluoperazine is similar to regular-dose olanzapine monotherapy in efficacy and safety for treatment of schizophrenia.The goal of this study is to compare the efficacy and safety of the olanzapine (10 mg/d) and olanzapine (5 mg/d) plus trifluoperazine (5 mg/d) in the treatment of acute psychotic exacerbations of schizophrenia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaohsiung Kai-Suan Psychiatric Hospital
• Collaborator: Department of Health, Executive Yuan, R.O.C. (Taiwan)
• Treatments: Olanzapine; Trifluoperazine

Criteria

Inclusion Criteria:

• were physically healthy and had all laboratory parameters within normal limits

• were aged 18 to 55 years

• satisfied the DSM-IV criteria for schizophrenia

• had baseline Clinical Global Impression-Severity of Illness (CGI-S) scale score of 4 or greater

• had no DSM-IV diagnosis of substance abuse or dependence (including alcohol)

• had not received depot antipsychotic drugs for the preceding 3 months

• gave written informed consent to participate in the study after a full explanation of the study's aims and procedures.

Exclusion Criteria:

• those with a history of serious adverse reaction to olanzapine or trifluoperazine or a history of tardive dyskinesia or neuroleptic malignant syndrome

• female subjects who were pregnant or at risk for pregnancy or lactation

• those that had a diagnosis of treatment-resistant schizophrenia or having previously received clozapine or electroconvulsive therapy