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

C

Chimei Medical Center

Status

Completed

Conditions

Major Depressive Disorder

Treatments

Drug: aripiprazole , sertraline

Study type

Interventional

Funder types

Other

Identifiers

NCT00873795
IRB 09603-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

41 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

41 participants in 2 patient groups, including a placebo group

aripiprazole and sertraline
Experimental group
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.
Treatment:
Drug: aripiprazole , sertraline
sertraline and placebo
Placebo Comparator group
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.
Treatment:
Drug: aripiprazole , sertraline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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