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

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: Aripiprazole 6-week group (Drug); Aripiprazole 8-week group (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Yong Min Ahn, MD. Ph.D., Principal Investigator, Affiliation: Seoul National University Hospital

Overall contact:
Eun Young Kim, MD, Phone: 82 2 2072 2456, Email: npeunyoung@gmail.com

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Quality of Life Scale (QOLS)

Secondary outcome: Montgomery-Ã…sberg Depression Rating Scale

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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Eun Young Kim, MD, Phone: 82 2 2072 2456, Email: npeunyoung@gmail.com

Seoul National University Hospital, Seoul 110-744, Korea, Republic of; Recruiting
Yong Min Ahn, MD, Ph.D., Phone: 82 2 2072 0710, Email: aym@snu.ac.kr
Yong Min Ahn, MD, Ph.D., Principal Investigator
Additional Information

Starting date: February 2012
Last updated: December 5, 2013

Page last updated: August 20, 2015

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