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

NCT ID: NCT00873795

Last Updated: 2009-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2009-03-31

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.

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

aripiprazole , sertraline

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

aripiprazole , sertraline

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chimei Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Chi Mei Medical Center

Principal Investigators

Fong-Lin Jang, M.D.

Role: STUDY_DIRECTOR

Chimei Medical Center

Locations

Psychiatry Department, Chimei Medical Center

Tainan City, , Taiwan

Countries

Taiwan

Other Identifiers

IRB 09603-001

Identifier Type: -

Identifier Source: org_study_id