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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 : Completed
First Posted : October 1, 2012
Last Update Posted : April 9, 2019
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Yong Min Ahn, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE July 31, 2012
First Posted Date  ICMJE October 1, 2012
Last Update Posted Date April 9, 2019
Actual Study Start Date  ICMJE February 10, 2012
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
Quality of Life Scale (QOLS) [ Time Frame: Change from Baseline at 8 weeks ]
change of Quality of Life Scale (QOLS)
Original Primary Outcome Measures  ICMJE
 (submitted: September 27, 2012)
Quality of Life Scale (QOLS) [ Time Frame: baseline, week 8 ]
Change History Complete list of historical versions of study NCT01696617 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
Montgomery-Åsberg Depression Rating Scale [ Time Frame: Change from Baseline at 8 weeks ]
change of Montgomery-Åsberg Depression Rating Scale
Original Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2012)
Montgomery-Åsberg Depression Rating Scale [ Time Frame: baseline, week 8 ]
Current Other Pre-specified Outcome Measures
 (submitted: September 6, 2018)
  • Hamilton Rating Scale for Depression [ Time Frame: Change from Baseline at 8 weeks ]
    change of Hamilton Rating Scale for Depression
  • Clinical Global Impression-severity, Clinical Global Impression-Improvement [ Time Frame: Change from Baseline at 8 weeks ]
    change of Clinical Global Impression-severity, Clinical Global Impression-Improvement
  • Beck Depression Inventory [ Time Frame: Change from Baseline at 8 weeks ]
    change of Beck Depression Inventory
  • Inventory of Depressive Symptomatology Self-Report Scale [ Time Frame: Change from Baseline at 8 weeks ]
    change of Inventory of Depressive Symptomatology Self-Report Scale
  • Drug - Induced Extrapyramidal Symptoms Scale [ Time Frame: Change from Baseline at 8 weeks ]
    change of Drug - Induced Extrapyramidal Symptoms Scale
  • The Liverpool University Neuroleptic Side Effect Rating Scale [ Time Frame: Change from Baseline at 8 weeks ]
    change of The Liverpool University Neuroleptic Side Effect Rating Scale
  • Short From-36 Health survey [ Time Frame: Change from Baseline at 8 weeks ]
    change of Short From-36 Health survey
Original Other Pre-specified Outcome Measures
 (submitted: September 27, 2012)
  • Hamilton Rating Scale for Depression [ Time Frame: baseline, week 8 ]
  • Clinical Global Impression-severity, Clinical Global Impression-Improvement [ Time Frame: baseline, week 8 ]
  • Beck Depression Inventory [ Time Frame: baseline, week 8 ]
  • Inventory of Depressive Symptomatology Self-Report Scale [ Time Frame: baseline, week 8 ]
  • Drug - Induced Extrapyramidal Symptoms Scale [ Time Frame: baseline, week 8 ]
  • The Liverpool University Neuroleptic Side Effect Rating Scale [ Time Frame: baseline, week 8 ]
  • Short From-36 Health survey [ Time Frame: baseline, week 8 ]
 
Descriptive Information
Brief Title  ICMJE Aripiprazole (Abilify®) as an Adjunctive Treatment for Inadequate Response in Major Depressive Disorder
Official Title  ICMJE Aripiprazole (Abilify®) as an Adjunctive Treatment for Inadequate Response in Major Depressive Disorder
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: Aripiprazole 6-week group
    Other Name: Abilify®
  • Drug: Aripiprazole 8-week group
    Other Name: Abilify®
Study Arms  ICMJE
  • Experimental: Aripiprazole 8-week group
    Adjunctive aripiprazole 8-week treatment
    Intervention: Drug: Aripiprazole 6-week group
  • Active Comparator: Aripiprazole 6-week group
    Adjunctive aripiprazole 6-week treatment
    Intervention: Drug: Aripiprazole 8-week group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2019)
46
Original Estimated Enrollment  ICMJE
 (submitted: September 27, 2012)
70
Actual Study Completion Date  ICMJE February 2019
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01696617
Other Study ID Numbers  ICMJE 031-KOC-1108i
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yong Min Ahn, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Otsuka Pharmaceutical Co., Ltd.
Investigators  ICMJE
Principal Investigator: Yong Min Ahn, MD. Ph.D. Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP