Aripiprazole (Abilify®) as an Adjunctive Treatment for In... | NCT01696617

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

NCT01696617

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Apr 9, 2019Actual

Enrollment

46Actual

Phase

Phase 4

Conditions

Major Depressive Disorder

Interventions

Aripiprazole 6-week group
Aripiprazole 8-week group

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 10, 2012Actual

Primary Completion Date

Dec 2016Actual

Completion Date

Feb 2019Actual

First Submitted Date

Jul 31, 2012

First Submission Date that Met QC Criteria

Sep 27, 2012

First Posted Date

Oct 1, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2019

Last Update Posted Date

Apr 9, 2019Actual

Name	Class
Otsuka Pharmaceutical Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aripiprazole 8-week group	Experimental	Adjunctive aripiprazole 8-week treatment	Drug: Aripiprazole 6-week group
Aripiprazole 6-week group	Active Comparator	Adjunctive aripiprazole 6-week treatment	Drug: Aripiprazole 8-week group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aripiprazole 6-week group	Drug		Aripiprazole 8-week group	Abilify®
Aripiprazole 8-week group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

ID	Term
D000068180	Aripiprazole
D044382	Population Groups

ID	Term
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D015363	Quinolones