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

NCT00873795 | Completed DMC

• 1 other identifier: IRB 09603-001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

efficacy; tolerability; combination of aripiprazole and SSRI(sertraline)

Outcome Measures

Primary Outcomes (1)

• score change of Hamilton Rating Scale For Depression (HAM-D17 )

  day 1 / 1 week / 2 weeks/ 4 weeks/ 6 weeks/ 10weeks

Secondary Outcomes (1)

• score change of Brief Psychiatric Rating Scale (BPRS-50)

  day 1/ 1 week / 2 weeks/ 4 weeks/ 6 weeks/ 10 weeks

Study Arms (2)

aripiprazole and sertraline

EXPERIMENTAL

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

sertraline and placebo

PLACEBO COMPARATOR

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

Interventions

aripiprazole , sertraline 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.

aripiprazole and sertraline; sertraline and placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chimei Medical Center: lead

Study Sites (1)

Psychiatry Department, Chimei Medical Center

Tainan, 700, Taiwan

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Aripiprazole; Sertraline

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; 1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Fong-Lin Jang, M.D.

  Chimei Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 31, 2009
• First Posted: April 2, 2009
• Study Start: April 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: April 2, 2009

Record last verified: 2009-04

Locations

TW (1)