Olanzapine vs. Low-dose Olanzapine Plus Trifluoperazine

NCT02704962 | Completed Phase 4 DMC

• 1 other identifier: KSPH-2011-22
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Schizophrenia

Keywords

schizophrenia; olanzapine; trifluoperazine; antipsychotic polypharmacy

Outcome Measures

Primary Outcomes (1)

• The changes in the Positive and Negative Syndrome Scale (PANSS) scores from baseline to the end of the study.

  The PANSS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).

Secondary Outcomes (17)

• The changes in the Clinical Global Impression-Severity (CGI-S) scores from baseline to the end of the study.

  The CGI-S was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).

• The changes in the Calgary Depression Scale for Schizophrenia (CDSS) scores from baseline to the end of the study.

  The CDSS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).

• The changes in the Global Assessment of Functioning (GAF) scores from baseline to the end of the study.

  The GAF was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).

• The changes in the Short-Form 36 (SF-36) scores from baseline to week 6.

  The SF-36 was rated at baseline and again at week 6.

• The changes in the Mini Mental State Examination (MMSE) scores from baseline to week 6.

  The MMSE was rated at baseline and again at week 6.

Study Arms (2)

trifluoperazine plus olanzapine

EXPERIMENTAL

trifluoperazine 5mg/day + olanzapine 5mg/day

Drug: full-dose olanzapine

full-dose olanzapine

ACTIVE COMPARATOR

olanzapine 10mg/day

Drug: full-dose olanzapine

Interventions

full-dose olanzapine DRUG

trifluoperazine 5mg/d

Also known as: polypharmacy

full-dose olanzapine; trifluoperazine plus olanzapine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Kai-Suan Psychiatric Hospital: lead
• Department of Health, Executive Yuan, R.O.C. (Taiwan): collaborator

Study Sites (2)

Kai-Suan Psychiatric Hospital

Kaohsiung City, 802, Taiwan

Location

Kai-Suan Psychiatric Hospital

Kaohsiung City, Taiwan

Location

Related Publications (3)

• Lin CH, Wang FC, Lin SC, Huang YH, Chen CC, Lane HY. Antipsychotic combination using low-dose antipsychotics is as efficacious and safe as, but cheaper, than optimal-dose monotherapy in the treatment of schizophrenia: a randomized, double-blind study. Int Clin Psychopharmacol. 2013 Sep;28(5):267-74. doi: 10.1097/YIC.0b013e3283633a83.

  PMID: 23778382 BACKGROUND

• Leucht S, Corves C, Arbter D, Engel RR, Li C, Davis JM. Second-generation versus first-generation antipsychotic drugs for schizophrenia: a meta-analysis. Lancet. 2009 Jan 3;373(9657):31-41. doi: 10.1016/S0140-6736(08)61764-X. Epub 2008 Dec 6.

  PMID: 19058842 RESULT

• Lin CH, Kuo CC, Chou LS, Chen YH, Chen CC, Huang KH, Lane HY. A randomized, double-blind comparison of risperidone versus low-dose risperidone plus low-dose haloperidol in treating schizophrenia. J Clin Psychopharmacol. 2010 Oct;30(5):518-25. doi: 10.1097/JCP.0b013e3181f28dff.

  PMID: 20814315 RESULT

MeSH Terms

Conditions

Schizophrenia

Interventions

Polypharmacy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Overtreatment; Medical Overuse; Health Services Misuse; Health Services; Health Care Facilities Workforce and Services; Attitude to Health; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Ching-Hua Lin, MD, PhD

  Kaohsiung Municipal Kai-Syuan Psychiatric Hospital, Kaohsiung City, Taiwan

  PRINCIPAL INVESTIGATOR

• Cheng-Chung Cheng, MD, PhD

  Kaohsiung Municipal Kai-Syuan Psychiatric Hospital, Kaohsiung City, Taiwan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Adult Psychiatry

Study Record Dates

• First Submitted: February 27, 2016
• First Posted: March 10, 2016
• Study Start: January 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 10, 2016

Record last verified: 2016-03

Locations

TW (2)