Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00873795
Recruitment Status : Completed
First Posted : April 2, 2009
Last Update Posted : April 2, 2009
Sponsor:
Information provided by:
Chimei Medical Center

Tracking Information
First Submitted Date  ICMJE March 31, 2009
First Posted Date  ICMJE April 2, 2009
Last Update Posted Date April 2, 2009
Study Start Date  ICMJE April 2007
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2009)
score change of Hamilton Rating Scale For Depression (HAM-D17 ) [ Time Frame: day 1 / 1 week / 2 weeks/ 4 weeks/ 6 weeks/ 10weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2009)
score change of Brief Psychiatric Rating Scale (BPRS-50) [ Time Frame: day 1/ 1 week / 2 weeks/ 4 weeks/ 6 weeks/ 10 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Compare the Efficacy and Tolerability of the Combination of Aripiprazole and Selective Serotonin Reuptake Inhibitors (SSRIs) Used in Major Depression
Official Title  ICMJE Efficacy and Safety of Aripiprazole 2.5mg Combine Sertraline 50mg in Major Depression
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: aripiprazole , sertraline
  • 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.
    Intervention: Drug: aripiprazole , sertraline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 1, 2009)
41
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00873795
Other Study ID Numbers  ICMJE IRB 09603-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fong-Lin Jang, Chi Mei Medical Center
Study Sponsor  ICMJE Chimei Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Fong-Lin Jang, M.D. Chimei Medical Center
PRS Account Chimei Medical Center
Verification Date April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP