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

Phase 4

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Aripiprazole 8-week group; Drug: Aripiprazole 6-week group

• Registration Number: NCT01696617
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-02-10
• Study First Submitted: 2012-07-31
• Study First Submitted QC: 2012-09-27
• Study First Posted: 2012-10-01
• Primary Completion: 2016-12
• Study Completion: 2019-02
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-08
• Last Update Posted: 2019-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aripiprazole 6-week group	Aripiprazole 8-week group	Adjunctive aripiprazole 6-week treatment
Aripiprazole 8-week group	Aripiprazole 6-week group	Adjunctive aripiprazole 8-week treatment

Primary Outcome Measures

Name	Time	Method
Quality of Life Scale (QOLS)	Change from Baseline at 8 weeks	change of Quality of Life Scale (QOLS)

Secondary Outcome Measures

Name	Time	Method
Montgomery-Åsberg Depression Rating Scale	Change from Baseline at 8 weeks	change of Montgomery-Åsberg Depression Rating Scale

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of