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

NCT01696617 | Completed Phase 4 DMC

• 1 other identifier: 031-KOC-1108i
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Quality of Life Scale (QOLS)

  change of Quality of Life Scale (QOLS)

  Change from Baseline at 8 weeks

Secondary Outcomes (1)

• Montgomery-Åsberg Depression Rating Scale

  Change from Baseline at 8 weeks

Other Outcomes (7)

• Hamilton Rating Scale for Depression

  Change from Baseline at 8 weeks

• Clinical Global Impression-severity, Clinical Global Impression-Improvement

  Change from Baseline at 8 weeks

• Beck Depression Inventory

  Change from Baseline at 8 weeks

Study Arms (2)

Aripiprazole 8-week group

EXPERIMENTAL

Adjunctive aripiprazole 8-week treatment

Drug: Aripiprazole 6-week group

Aripiprazole 6-week group

ACTIVE COMPARATOR

Adjunctive aripiprazole 6-week treatment

Drug: Aripiprazole 8-week group

Interventions

Aripiprazole 6-week group DRUG

Also known as: Abilify®

Aripiprazole 8-week group

Aripiprazole 8-week group DRUG

Also known as: Abilify®

Aripiprazole 6-week group

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Aripiprazole; Population Groups

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; Demography; Population Characteristics

Study Officials

• Yong Min Ahn, MD. Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 31, 2012
• First Posted: October 1, 2012
• Study Start: February 10, 2012
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2019
• Last Updated: April 9, 2019

Record last verified: 2019-04

Locations

KR (1)