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

This study is currently recruiting participants.
Verified April 2013 by Seoul National University Hospital
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Yong Min Ahn, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01696617
First received: July 31, 2012
Last updated: April 12, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
 Drug: Aripiprazole 6-week group
Drug: Aripiprazole 8-week group
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Aripiprazole (Abilify®) as an Adjunctive Treatment for Inadequate Response in Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Quality of Life Scale (QOLS) [ Time Frame: Change from Baseline at 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Montgomery-Åsberg Depression Rating Scale [ Time Frame: Change from Baseline at 8 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Hamilton Rating Scale for Depression [ Time Frame: Change from Baseline at 8 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression-severity, Clinical Global Impression-Improvement [ Time Frame: Change from Baseline at 8 weeks ] [ Designated as safety issue: No ]
  • Beck Depression Inventory [ Time Frame: Change from Baseline at 8 weeks ] [ Designated as safety issue: No ]
  • Inventory of Depressive Symptomatology Self-Report Scale [ Time Frame: Change from Baseline at 8 weeks ] [ Designated as safety issue: No ]
  • Drug - Induced Extrapyramidal Symptoms Scale [ Time Frame: Change from Baseline at 8 weeks ] [ Designated as safety issue: Yes ]
  • The Liverpool University Neuroleptic Side Effect Rating Scale [ Time Frame: Change from Baseline at 8 weeks ] [ Designated as safety issue: Yes ]
  • Short From-36 Health survey [ Time Frame: Change from Baseline at 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: February 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aripiprazole 8-week group
Adjunctive aripiprazole 8-week treatment
 Drug: Aripiprazole 6-week group
Other Name: Abilify®
Active Comparator: Aripiprazole 6-week group
Adjunctive aripiprazole 6-week treatment
 Drug: Aripiprazole 8-week group
Other Name: Abilify®

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696617

Contacts
Contact: Eun Young Kim, MD 82 2 2072 2457 npeunyoung@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Yong Min Ahn, MD, Ph.D.     82 2 2072 0710     aym@snu.ac.kr    
Principal Investigator: Yong Min Ahn, MD, Ph.D.            
Sponsors and Collaborators
Seoul National University Hospital
Otsuka Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Yong Min Ahn, MD. Ph.D. Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Yong Min Ahn, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01696617     History of Changes
Other Study ID Numbers: 031-KOC-1108i
Study First Received: July 31, 2012
Last Updated: April 12, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Aripiprazole
Antipsychotic Agents
 Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 23, 2013