Status:
COMPLETED
Compare the Efficacy and Tolerability of the Combination of Aripiprazole and Selective Serotonin Reuptake Inhibitors (SSRIs) Used in Major Depression
Lead Sponsor:
Chimei Medical Center
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 ...
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 baselin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00873795
Start Date
April 1 2007
End Date
March 1 2009
Last Update
April 2 2009
Active Locations (1)
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1
Psychiatry Department, Chimei Medical Center
Tainan, Taiwan, 700