Aripiprazole (Abilify®) as an Adjunctive Treatment for Inadequate Response in Major Depressive Disorder

Overview

The investigators hypothesized that combined pharmacotherapy using adjunctive aripiprazole of standard antidepressants would be associated with improved depression response in Major depressive disorder, especially in Quality of life. The investigators compare the mean changes in the quality of life between before add-on and 8 weeks treatment of aripiprazole and between before add-on and 6 weeks treatment of aripiprazole.

Full Title of Study: “Aripiprazole (Abilify®) as an Adjunctive Treatment for Inadequate Response in Major Depressive Disorder”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2016

Detailed Description

Previous study about quality of life measurement in patients with depression have been reported that quality of life have to be measured irrespective with the severity of depression because quality of life has some other aspect to depression.The investigators have designed a 6-week single blinded study with flexible dose aripiprazole augmentation, ranging from 2.5mg to maximum 20 mg (15mg for patients on fluoxetine or paroxetine), in patients who responded inadequately (a score of >18 on the MADRS) to first-line antidepressant pharmacotherapy. The investigators compare the mean changes from in the quality of life at 8 weeks.

Interventions

  • Drug: Aripiprazole 6-week group
  • Drug: Aripiprazole 8-week group

Arms, Groups and Cohorts

  • Experimental: Aripiprazole 8-week group
    • Adjunctive aripiprazole 8-week treatment
  • Active Comparator: Aripiprazole 6-week group
    • Adjunctive aripiprazole 6-week treatment

Clinical Trial Outcome Measures

Primary Measures

  • Quality of Life Scale (QOLS)
    • Time Frame: Change from Baseline at 8 weeks
    • change of Quality of Life Scale (QOLS)

Secondary Measures

  • Montgomery-Åsberg Depression Rating Scale
    • Time Frame: Change from Baseline at 8 weeks
    • change of Montgomery-Åsberg Depression Rating Scale

Participating in This Clinical Trial

Inclusion Criteria

  • Age : 18-65 – Patients with major depressive disorder according to DSM-IV criteria that have lasted >8 weeks – MADRS total score of 18 or higher – Patients who responded inadequately (a score of >18 on the MADRS) to first-line antidepressant treatment of 4 week duration – Current use of standard antidepressant treatment in monotherapy or combination of 2 antidepressants : escitalopram (10 – 20mg/d), fluoxetine(20 – 40mg/d), paroxetine CR(25 – 50mg/d), sertraline(100 – 150mg/d), mirtazapine (15 – 45mg/d), duloxetine (30 – 60mg/d) or venlafaxine ER(150-225mg/d) Exclusion Criteria:

  • Past history of hypersensitivity to aripiprazole – Primary diagnosis of MDD with psychotic feature, bipolar disorder, schizophrenia, schizoaffective disorder, other psychotic disorder or anxiety disorder, a history of alcohol/ drug abuse within the past 12 months, or a diagnosis of dementia – Clinically significant current Axis II (DSM-IV-TR) diagnosis – A significant risk of suicide corroborated by a score of ≥5 on item 10(suicidal thoughts) on the MADRS scale or by clinical judgment of the investigator – Pregnancy or in breast-feeding – Presence of a serious medical illness including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease or physical disorder judged to significantly affect central nervous system function – Patients taking antipsychotics, mood stabilizer or any psychotropic medications besides antidepressants, except benzodiazepines or beta blockers or hypnotics – Patients with past treatment failures of aripiprazole

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Collaborator
    • Otsuka Pharmaceutical Co., Ltd.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yong Min Ahn, Professor – Seoul National University Hospital
  • Overall Official(s)
    • Yong Min Ahn, MD. Ph.D., Principal Investigator, Seoul National University Hospital

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