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

Sponsor

Chimei Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00873795

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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 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 or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: aripiprazole , sertraline	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2007

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

score change of Hamilton Rating Scale For Depression (HAM-D17 ) [day 1 / 1 week / 2 weeks/ 4 weeks/ 6 weeks/ 10weeks]

Secondary Outcome Measures

score change of Brief Psychiatric Rating Scale (BPRS-50) [day 1/ 1 week / 2 weeks/ 4 weeks/ 6 weeks/ 10 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.