Back to resultsCompare the Efficacy and Tolerability of the Combination of Aripiprazole and Selective Serotonin Reuptake Inhibitors (SSRIs) Used in Major Depression
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
aripiprazole , sertraline
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring efficacy, tolerability, combination of aripiprazole and SSRI(sertraline)
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.
Sites / Locations
- Psychiatry Department, Chimei Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
aripiprazole and sertraline
sertraline and placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
score change of Hamilton Rating Scale For Depression (HAM-D17 )
Secondary Outcome Measures
score change of Brief Psychiatric Rating Scale (BPRS-50)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00873795
Brief Title
Compare the Efficacy and Tolerability of the Combination of Aripiprazole and Selective Serotonin Reuptake Inhibitors (SSRIs) Used in Major Depression
Official Title
Efficacy and Safety of Aripiprazole 2.5mg Combine Sertraline 50mg in Major Depression
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chimei Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
efficacy, tolerability, combination of aripiprazole and SSRI(sertraline)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
aripiprazole and sertraline
Arm Type
Experimental
Arm Description
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.
Arm Title
sertraline and placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
aripiprazole , sertraline
Intervention Description
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.
Primary Outcome Measure Information:
Title
score change of Hamilton Rating Scale For Depression (HAM-D17 )
Time Frame
day 1 / 1 week / 2 weeks/ 4 weeks/ 6 weeks/ 10weeks
Secondary Outcome Measure Information:
Title
score change of Brief Psychiatric Rating Scale (BPRS-50)
Time Frame
day 1/ 1 week / 2 weeks/ 4 weeks/ 6 weeks/ 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fong-Lin Jang, M.D.
Organizational Affiliation
Chimei Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Psychiatry Department, Chimei Medical Center
City
Tainan
ZIP/Postal Code
700
Country
Taiwan
12. IPD Sharing Statement
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Compare the Efficacy and Tolerability of the Combination of Aripiprazole and Selective Serotonin Reuptake Inhibitors (SSRIs) Used in Major Depression
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