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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Aripiprazole 6-week group
Aripiprazole 8-week group
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aripiprazole 8-week group

Aripiprazole 6-week group

Arm Description

Adjunctive aripiprazole 8-week treatment

Adjunctive aripiprazole 6-week treatment

Outcomes

Primary Outcome Measures

Quality of Life Scale (QOLS)
change of Quality of Life Scale (QOLS)

Secondary Outcome Measures

Montgomery-Åsberg Depression Rating Scale
change of Montgomery-Åsberg Depression Rating Scale

Full Information

First Posted
July 31, 2012
Last Updated
April 8, 2019
Sponsor
Seoul National University Hospital
Collaborators
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01696617
Brief Title
Aripiprazole (Abilify®) as an Adjunctive Treatment for Inadequate Response in Major Depressive Disorder
Official Title
Aripiprazole (Abilify®) as an Adjunctive Treatment for Inadequate Response in Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 10, 2012 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aripiprazole 8-week group
Arm Type
Experimental
Arm Description
Adjunctive aripiprazole 8-week treatment
Arm Title
Aripiprazole 6-week group
Arm Type
Active Comparator
Arm Description
Adjunctive aripiprazole 6-week treatment
Intervention Type
Drug
Intervention Name(s)
Aripiprazole 6-week group
Other Intervention Name(s)
Abilify®
Intervention Type
Drug
Intervention Name(s)
Aripiprazole 8-week group
Other Intervention Name(s)
Abilify®
Primary Outcome Measure Information:
Title
Quality of Life Scale (QOLS)
Description
change of Quality of Life Scale (QOLS)
Time Frame
Change from Baseline at 8 weeks
Secondary Outcome Measure Information:
Title
Montgomery-Åsberg Depression Rating Scale
Description
change of Montgomery-Åsberg Depression Rating Scale
Time Frame
Change from Baseline at 8 weeks
Other Pre-specified Outcome Measures:
Title
Hamilton Rating Scale for Depression
Description
change of Hamilton Rating Scale for Depression
Time Frame
Change from Baseline at 8 weeks
Title
Clinical Global Impression-severity, Clinical Global Impression-Improvement
Description
change of Clinical Global Impression-severity, Clinical Global Impression-Improvement
Time Frame
Change from Baseline at 8 weeks
Title
Beck Depression Inventory
Description
change of Beck Depression Inventory
Time Frame
Change from Baseline at 8 weeks
Title
Inventory of Depressive Symptomatology Self-Report Scale
Description
change of Inventory of Depressive Symptomatology Self-Report Scale
Time Frame
Change from Baseline at 8 weeks
Title
Drug - Induced Extrapyramidal Symptoms Scale
Description
change of Drug - Induced Extrapyramidal Symptoms Scale
Time Frame
Change from Baseline at 8 weeks
Title
The Liverpool University Neuroleptic Side Effect Rating Scale
Description
change of The Liverpool University Neuroleptic Side Effect Rating Scale
Time Frame
Change from Baseline at 8 weeks
Title
Short From-36 Health survey
Description
change of Short From-36 Health survey
Time Frame
Change from Baseline at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Min Ahn, MD. Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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

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