A Phase 4 interventional study of full-dose olanzapine in Schizophrenia, sponsored by Kaohsiung Kai-Suan Psychiatric Hospital. Completed at 2 sites in Taiwan. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2016-03-10.
Sponsored by Kaohsiung Kai-Suan Psychiatric Hospital · Phase 4, Interventional, and Treatment
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.
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).
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's enrollment of 94 is above the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Kaohsiung Kai-Suan Psychiatric Hospital is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
trifluoperazine 5mg/day + olanzapine 5mg/day
Drug: full-dose olanzapine
olanzapine 10mg/day
Drug: full-dose olanzapine
trifluoperazine 5mg/d
Also known as: polypharmacy
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 record gives a start of Jan 2012, a primary completion of Feb 2016 and a completion of Feb 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Kaohsiung Kai-Suan Psychiatric Hospital