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

Major Depressive Disorder Clinical Trial

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

Status Completed

Clinical Trial 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 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

• NCT number: NCT00873795
• Study type: Interventional
• Source: Chimei Medical Center
• Status: Completed
• Phase: N/A
• Start date: April 2007
• Completion date: March 2009