Compare the Efficacy and Tolerability of the Combination of Aripiprazole and Selective Serotonin Reuptake Inhibitors (SSRIs) Used in Major Depression

Study Overview
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Brief Summary
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FDA has accepted atypical antipsychotics of olanzapine and aripiprazole as the adjuvant medications for refractory major depression. But there is still no trial about atypical antipsychotics combined with antidepressant of SSRI used in fresh major depressive patients. This project aims to compare the efficacy and tolerability of sertraline with or without low-dosed aripiprazole added in fresh major depression.

Detailed Description
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This double-blind, placebo-control, fixed dose, randomized study will be conducted at a tertiary clinical setting. Patients over 18 y/o fulfilled DSM-IV criteria for major depression, having a baseline HAM-D score ≧ 14 and a HAM-D item 3 score < 3 will be recruited into the groups. The study group of patients will receive ten weeks of treatment with a combination of fix-dosed sertraline and aripiprazole. The control group will received sertraline only. The score reduction in HAM-D17, CGI, SF-36 and Brief Symptom Rating Scale (BSRS-50) will be periodically estimated as an efficacy following the use of a SSRIs or and aripiprazole.

Official Title
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Efficacy and Safety of Aripiprazole 2.5mg Combine Sertraline 50mg in Major Depression

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: aripiprazole , sertraline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects 18 to 65 years inclusive. Fulfilled DSM-Ⅳ criteria for major depressive disorder. Onset ≧2 weeks. Baseline score ≧14 on the HAM-D17. Written informed consent prior to entry into the study. Exclusion Criteria: HAM-D17 item 3 score≧3. Life-time history of bipolar disorders, schizophrenia or schizoaffective disorder. Current history of panic disorder, obsessive-compulsive disorder, alcohol or substance abuse. Mood disorder due to general medical condition. Treatment with antidepressants at entry into the study before 2 weeks. Need for psychoactive medications other than the study drugs, except for one benzodiazepine or hypnotic given at a stable dose. Known intolerance or inefficacy to either drug. Previous lack of response to two or more antidepressants at adequate dosage. Subjects who have acute or unstable medical illness or organic failure. Pregnancy and breast-feeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aripiprazole and sertraline<br>The patients of this arm receive ten weeks of treatment with a combination of sertraline 50mg/day and aripiprazole 2.5mg/day.The effect of this arm is assessed for HAM-D17, CGI, SF-36 and BSRS-50. | Drug: aripiprazole , sertraline<br>* In this ten weeks,double-blind,placebo-control,randomized,fixed dose study, study,subjects were randomly assigned to treatment with aripiprazole 2.5mg/day plus sertraline 50mg/day or sertraline 50mg/day plus placebo.<br>|
| Placebo Comparator: sertraline and placebo<br>The patients of this arm receive ten weeks of treatment with a combination of sertraline 50mg/day and placebo.The effect of this arm is assessed for HAM-D17, CGI, SF-36 and BSRS-50. | Drug: aripiprazole , sertraline<br>* In this ten weeks,double-blind,placebo-control,randomized,fixed dose study, study,subjects were randomly assigned to treatment with aripiprazole 2.5mg/day plus sertraline 50mg/day or sertraline 50mg/day plus placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| score change of Hamilton Rating Scale For Depression (HAM-D17 ) |  | day 1 / 1 week / 2 weeks/ 4 weeks/ 6 weeks/ 10weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| score change of Brief Psychiatric Rating Scale (BPRS-50) |  | day 1/ 1 week / 2 weeks/ 4 weeks/ 6 weeks/ 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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efficacy, tolerability, combination of aripiprazole and SSRI(sertraline)