Olanzapine vs. Low-dose Olanzapine Plus Trifluoperazine

March 4, 2016 updated by: Ching-Hua Lin, MD, PhD, Kaohsiung Kai-Suan Psychiatric Hospital

A Randomized, Double-blind, Comparison of the Efficacy and Safety of Olanzapine Versus Low-dose Olanzapine Plus Low-dose Trifluoperazine in the Treatment of Schizophrenia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Antipsychotic monotherapy is recognized as the treatment of choice for patients with schizophrenia. Surveys have shown that antipsychotic polypharmacy are frequently prescribed, yet few randomized, double-blind clinical trials have examined this practice. Olanzapine, an atypical antipsychotic agent, has low incidence of extrapyramidal symptom but with high cost compared to trifluoperazine. It has been reported that mean doses of typical antipsychotics less than 600 mg per day of chlorpromazine or its equivalent has no higher risk of extrapyramidal symptom than atypical antipsychotics. The objective of the study is to compare the efficacy and safety of the olanzapine (10 mg per day) and olanzapine (5 mg per day) plus trifluoperazine (5 mg per day) in the treatment of acute psychotic exacerbations of schizophrenia. In this 6-week, double-blind, fixed-dose study, patients with schizophrenia are randomly assigned to olanzapine (10 mg per day)) or olanzapine (5 mg per day) plus trifluoperazine (5 mg per day). The hypothesis is that the two treatment groups have the similar efficacy and safety, but different cost. The primary efficacy measure is change from baseline in Positive and Negative Syndrome Scale (PANSS) total scores; secondary outcomes include Clinical Global Impression-Severity (CGI-S), the Calgary Depression Scale for Schizophrenia (CDSS), Global Assessment of Functioning Scale (GAF), Short Form-36 (SF-36), Mini Mental State Examination (MMSE). Safety assessments include the change from baseline on Simpson-Angus Rating Scale (SAS), Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Scale (BAS), and UKU Side-effects Rating Scale, and the change from baseline in prolactin levels, body weight, vital sign, blood pressure, Bazett's correction of QT interval (QTc interval), fasting glucose level, and lipid panel (cholesterol, high density lipid protein, low density lipid protein, and triglyceride).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
94

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 802
        • Kai-Suan Psychiatric Hospital
      • Kaohsiung, Taiwan
        • Kai-Suan Psychiatric Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: trifluoperazine plus olanzapine
trifluoperazine 5mg/day + olanzapine 5mg/day
Drug: full-dose olanzapine
trifluoperazine 5mg/d
Other Names:
  • polypharmacy
Active Comparator: full-dose olanzapine
olanzapine 10mg/day
Drug: full-dose olanzapine
trifluoperazine 5mg/d
Other Names:
  • polypharmacy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The changes in the Positive and Negative Syndrome Scale (PANSS) scores from baseline to the end of the study.
Time Frame: The PANSS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
The PANSS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The changes in the Clinical Global Impression-Severity (CGI-S) scores from baseline to the end of the study.
Time Frame: The CGI-S was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
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.
Time Frame: The CDSS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
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.
Time Frame: The GAF was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
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.
Time Frame: The SF-36 was rated at baseline and again at 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.
Time Frame: The MMSE was rated at baseline and again at week 6.
The MMSE was rated at baseline and again at week 6.
The changes in the Simpson-Angus Rating Scale (SAS) scores from baseline to the end of the study.
Time Frame: The SAS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
The SAS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
The changes in the Abnormal Involuntary Movement Scale (AIMS) scores from baseline to the end of the study.
Time Frame: The AIMS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
The AIMS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
The changes in the Barnes Akathisia Scale (BAS) scores from baseline to the end of the study.
Time Frame: The BAS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
The BAS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
The changes in the UKU Side-effects Rating Scale (UKU) scores from baseline to the end of the study.
Time Frame: The UKU was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
The UKU was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
The changes in the Bazett's correction of QT interval (QTc interval) from baseline to week 6.
Time Frame: The QTc interval was assayed at baseline and again at week 6.
The QTc interval was assayed at baseline and again at week 6.
The changes in the body weight from baseline to the end of the study.
Time Frame: The body weight was assayed at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
The body weight was assayed at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
The changes in the fasting glucose level from baseline to week 6.
Time Frame: The fasting glucose level was assayed at baseline and again at week 6.
The fasting glucose level was assayed at baseline and again at week 6.
The changes in the prolactin level from baseline to week 6.
Time Frame: The prolactin level was assayed at baseline and again at week 6.
The prolactin level was assayed at baseline and again at week 6.
The changes in the cholesterol level from baseline to week 6.
Time Frame: The cholesterol level was assayed at baseline and again at week 6.
The cholesterol level was assayed at baseline and again at week 6.
The changes in the high density lipoprotein (HDL) level from baseline to week 6.
Time Frame: The HDL level was assayed at baseline and again at week 6.
The HDL level was assayed at baseline and again at week 6.
The changes in the low density lipoprotein (LDL) level from baseline to week 6.
Time Frame: The LDL level was assayed at baseline and again at week 6.
The LDL level was assayed at baseline and again at week 6.
The changes in the triglyceride level from baseline to week 6.
Time Frame: The triglyceride level was assayed at baseline and again at week 6.
The triglyceride level was assayed at baseline and again at week 6.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaohsiung Kai-Suan Psychiatric Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Department of Health, Executive Yuan, R.O.C. (Taiwan)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ching-Hua Lin, MD, PhD, Kaohsiung Municipal Kai-Syuan Psychiatric Hospital, Kaohsiung City, Taiwan
  • Study Chair: Cheng-Chung Cheng, MD, PhD, Kaohsiung Municipal Kai-Syuan Psychiatric Hospital, Kaohsiung City, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KSPH-2011-22

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