Schizophrenia Clinical Trial
Official title:
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
Verified date | March 2016 |
Source | Kaohsiung Kai-Suan Psychiatric Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Department of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 94 |
Est. completion date | February 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Kai-Suan Psychiatric Hospital | Kaohsiung | |
Taiwan | Kai-Suan Psychiatric Hospital | Kaohsiung |
Lead Sponsor | Collaborator |
---|---|
Kaohsiung Kai-Suan Psychiatric Hospital | Department of Health, Executive Yuan, R.O.C. (Taiwan) |
Taiwan,
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. — View Citation
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 — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | No | |
Secondary | 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). | No | |
Secondary | 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). | No | |
Secondary | 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). | No | |
Secondary | 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. | No | |
Secondary | 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. | No | |
Secondary | The changes in the Simpson-Angus Rating Scale (SAS) scores from baseline to the end of the study. | The SAS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination). | Yes | |
Secondary | The changes in the Abnormal Involuntary Movement Scale (AIMS) scores from baseline to the end of the study. | The AIMS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination). | Yes | |
Secondary | The changes in the Barnes Akathisia Scale (BAS) scores from baseline to the end of the study. | The BAS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination). | Yes | |
Secondary | The changes in the UKU Side-effects Rating Scale (UKU) scores from baseline to the end of the study. | The UKU was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination). | Yes | |
Secondary | The changes in the Bazett's correction of QT interval (QTc interval) from baseline to week 6. | The QTc interval was assayed at baseline and again at week 6. | Yes | |
Secondary | The changes in the body weight from baseline to the end of the study. | The body weight was assayed at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination). | Yes | |
Secondary | The changes in the fasting glucose level from baseline to week 6. | The fasting glucose level was assayed at baseline and again at week 6. | Yes | |
Secondary | The changes in the prolactin level from baseline to week 6. | The prolactin level was assayed at baseline and again at week 6. | Yes | |
Secondary | The changes in the cholesterol level from baseline to week 6. | The cholesterol level was assayed at baseline and again at week 6. | Yes | |
Secondary | The changes in the high density lipoprotein (HDL) level from baseline to week 6. | The HDL level was assayed at baseline and again at week 6. | Yes | |
Secondary | The changes in the low density lipoprotein (LDL) level from baseline to week 6. | The LDL level was assayed at baseline and again at week 6. | Yes | |
Secondary | The changes in the triglyceride level from baseline to week 6. | The triglyceride level was assayed at baseline and again at week 6. | Yes |
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