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:
Information provided by:
Chimei Medical Center
ClinicalTrials.gov Identifier:
NCT00873795
First received: March 31, 2009
Last updated: April 1, 2009
Last verified: April 2009
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873795

Locations
Taiwan
Psychiatry Department, Chimei Medical Center
Tainan, Taiwan, 700
Sponsors and Collaborators
Chimei Medical Center
Investigators
Study Director: Fong-Lin Jang, M.D. Chimei Medical Center
  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 July 22, 2014