Compare the Efficacy and Tolerability of the Combination of Aripiprazole and Selective Serotonin Reuptake Inhibitors (SSRIs) Used in Major Depression
This study has been completed.
Sponsor:
Chimei Medical Center
Information provided by:
Chimei Medical Center
ClinicalTrials.gov Identifier:
NCT00873795
First received: March 31, 2009
Last updated: April 1, 2009
Last verified: April 2009
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Purpose
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 |
|---|---|
|
Major Depressive Disorder |
Drug: aripiprazole , sertraline |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Efficacy and Safety of Aripiprazole 2.5mg Combine Sertraline 50mg in Major Depression |
Resource links provided by NLM:
Further study details as provided by Chimei Medical Center:
Primary Outcome Measures:
- score change of Hamilton Rating Scale For Depression (HAM-D17 ) [ Time Frame: day 1 / 1 week / 2 weeks/ 4 weeks/ 6 weeks/ 10weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- score change of Brief Psychiatric Rating Scale (BPRS-50) [ Time Frame: day 1/ 1 week / 2 weeks/ 4 weeks/ 6 weeks/ 10 weeks ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Experimental: aripiprazole and sertraline
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
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.
|
|
Placebo Comparator: sertraline and placebo
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
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.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Fong-Lin Jang, Chi Mei Medical Center |
| ClinicalTrials.gov Identifier: | NCT00873795 History of Changes |
| Other Study ID Numbers: | IRB 09603-001 |
| Study First Received: | March 31, 2009 |
| Last Updated: | April 1, 2009 |
| Health Authority: | Taiwan: Institutional Review Board |
Keywords provided by Chimei Medical Center:
|
efficacy tolerability combination of aripiprazole and SSRI(sertraline) |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Sertraline Serotonin Uptake Inhibitors Aripiprazole Antidepressive Agents Psychotropic Drugs |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants |
ClinicalTrials.gov processed this record on May 16, 2013