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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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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

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: aripiprazole , sertraline Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Aripiprazole 2.5mg Combine Sertraline 50mg in Major Depression
Study Start Date : April 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

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Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 Measures :
  1. score change of Brief Psychiatric Rating Scale (BPRS-50) [ Time Frame: day 1/ 1 week / 2 weeks/ 4 weeks/ 6 weeks/ 10 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00873795


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

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Responsible Party: Fong-Lin Jang, Chi Mei Medical Center
ClinicalTrials.gov Identifier: NCT00873795     History of Changes
Other Study ID Numbers: IRB 09603-001
First Posted: April 2, 2009    Key Record Dates
Last Update Posted: April 2, 2009
Last Verified: April 2009
Keywords provided by Chimei Medical Center:
efficacy
tolerability
combination of aripiprazole and SSRI(sertraline)
Additional relevant MeSH terms:
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Aripiprazole
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators