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Sponsored by: |
Chimei Medical Center |
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Information provided by: | Chimei Medical Center |
ClinicalTrials.gov Identifier: | NCT00873795 |
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.
Condition | Intervention |
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Major Depressive Disorder |
Drug: aripiprazole , sertraline |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of Aripiprazole 2.5mg Combine Sertraline 50mg in Major Depression |
Enrollment: | 41 |
Study Start Date: | April 2007 |
Study Completion Date: | March 2009 |
Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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aripiprazole and sertraline: Experimental
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.
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Drug: aripiprazole , sertraline
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.
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sertraline and placebo: Placebo Comparator
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.
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Drug: aripiprazole , sertraline
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.
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Chi Mei Medical Center ( Fong-Lin Jang ) |
Study ID Numbers: | IRB 09603-001 |
Study First Received: | March 31, 2009 |
Last Updated: | April 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00873795 History of Changes |
Health Authority: | Taiwan: Institutional Review Board |
efficacy tolerability combination of aripiprazole and SSRI(sertraline) |
Neurotransmitter Agents Tranquilizing Agents Depression Psychotropic Drugs Central Nervous System Depressants Depressive Disorder, Major Antipsychotic Agents Depressive Disorder |
Serotonin Uptake Inhibitors Serotonin Behavioral Symptoms Mental Disorders Mood Disorders Sertraline Aripiprazole Antidepressive Agents |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Tranquilizing Agents Depression Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Depressive Disorder, Major Antipsychotic Agents Depressive Disorder |
Serotonin Uptake Inhibitors Pharmacologic Actions Behavioral Symptoms Serotonin Agents Mental Disorders Therapeutic Uses Mood Disorders Sertraline Aripiprazole Central Nervous System Agents Antidepressive Agents |