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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Aripiprazole 6-week group; Drug: Aripiprazole 8-week group

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: Interventional
• Enrollment (Actual): 46
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aripiprazole 8-week group; Adjunctive aripiprazole 8-week treatment	Drug: Aripiprazole 6-week group; Other Names: Abilify®
Active Comparator: Aripiprazole 6-week group; Adjunctive aripiprazole 6-week treatment	Drug: Aripiprazole 8-week group; Other Names: Abilify®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Scale (QOLS)	change of Quality of Life Scale (QOLS)	Change from Baseline at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery-Åsberg Depression Rating Scale	change of Montgomery-Åsberg Depression Rating Scale	Change from Baseline at 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Rating Scale for Depression	change of Hamilton Rating Scale for Depression	Change from Baseline at 8 weeks
Clinical Global Impression-severity, Clinical Global Impression-Improvement	change of Clinical Global Impression-severity, Clinical Global Impression-Improvement	Change from Baseline at 8 weeks
Beck Depression Inventory	change of Beck Depression Inventory	Change from Baseline at 8 weeks
Inventory of Depressive Symptomatology Self-Report Scale	change of Inventory of Depressive Symptomatology Self-Report Scale	Change from Baseline at 8 weeks
Drug - Induced Extrapyramidal Symptoms Scale	change of Drug - Induced Extrapyramidal Symptoms Scale	Change from Baseline at 8 weeks
The Liverpool University Neuroleptic Side Effect Rating Scale	change of The Liverpool University Neuroleptic Side Effect Rating Scale	Change from Baseline at 8 weeks
Short From-36 Health survey	change of Short From-36 Health survey	Change from Baseline at 8 weeks

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Otsuka Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Yong Min Ahn, MD. Ph.D., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2012
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: July 31, 2012
• First Submitted That Met QC Criteria: September 27, 2012
• First Posted (Estimate): October 1, 2012

Study Record Updates

• Last Update Posted (Actual): April 9, 2019
• Last Update Submitted That Met QC Criteria: April 8, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole
• Other Study ID Numbers: 031-KOC-1108i