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

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ClinicalTrials.gov Identifier: NCT01696617
Recruitment Status : Unknown
Verified December 2015 by Yong Min Ahn, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : October 1, 2012
Last Update Posted : December 8, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Aripiprazole 6-week group Drug: Aripiprazole 8-week group Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aripiprazole (Abilify®) as an Adjunctive Treatment for Inadequate Response in Major Depressive Disorder
Study Start Date : February 2012
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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®


Outcome Measures

Primary Outcome Measures :
  1. Quality of Life Scale (QOLS) [ Time Frame: Change from Baseline at 8 weeks ]

Secondary Outcome Measures :
  1. Montgomery-Åsberg Depression Rating Scale [ Time Frame: Change from Baseline at 8 weeks ]

Other Outcome Measures:
  1. Hamilton Rating Scale for Depression [ Time Frame: Change from Baseline at 8 weeks ]
  2. Clinical Global Impression-severity, Clinical Global Impression-Improvement [ Time Frame: Change from Baseline at 8 weeks ]
  3. Beck Depression Inventory [ Time Frame: Change from Baseline at 8 weeks ]
  4. Inventory of Depressive Symptomatology Self-Report Scale [ Time Frame: Change from Baseline at 8 weeks ]
  5. Drug - Induced Extrapyramidal Symptoms Scale [ Time Frame: Change from Baseline at 8 weeks ]
  6. The Liverpool University Neuroleptic Side Effect Rating Scale [ Time Frame: Change from Baseline at 8 weeks ]
  7. Short From-36 Health survey [ Time Frame: Change from Baseline at 8 weeks ]

Eligibility Criteria

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

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): NCT01696617


Contacts
Contact: Eun Young Kim, MD 82 2 2072 2456 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

Responsible Party: Yong Min Ahn, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01696617     History of Changes
Other Study ID Numbers: 031-KOC-1108i
First Posted: October 1, 2012    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: December 2015

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