Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 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
Actual Study Start Date : February 10, 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


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®




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


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


Other Outcome Measures:
  1. Hamilton Rating Scale for Depression [ Time Frame: Change from Baseline at 8 weeks ]
    change of Hamilton Rating Scale for Depression

  2. 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

  3. Beck Depression Inventory [ Time Frame: Change from Baseline at 8 weeks ]
    change of Beck Depression Inventory

  4. Inventory of Depressive Symptomatology Self-Report Scale [ Time Frame: Change from Baseline at 8 weeks ]
    change of Inventory of Depressive Symptomatology Self-Report Scale

  5. Drug - Induced Extrapyramidal Symptoms Scale [ Time Frame: Change from Baseline at 8 weeks ]
    change of Drug - Induced Extrapyramidal Symptoms Scale

  6. 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

  7. Short From-36 Health survey [ Time Frame: Change from Baseline at 8 weeks ]
    change of Short From-36 Health survey



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

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


Locations
Layout table for location information
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Otsuka Pharmaceutical Co., Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Yong Min Ahn, MD. Ph.D. Seoul National University Hospital

Layout table for additonal 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: April 9, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Aripiprazole
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists