Clinical trial NCT01696617: Aripiprazole (Abilify®) as an Adjunctive Treatment for Inadequate Response in Major Depressive Disorder
Official title: Aripiprazole (Abilify®) as an Adjunctive Treatment for Inadequate Response in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2012-10-01
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Quality of Life Scale (QOLS)
timeFrame: Change from Baseline at 8 weeks
Secondary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale
timeFrame: Change from Baseline at 8 weeks
Other outcomes:
measure: Hamilton Rating Scale for Depression
timeFrame: Change from Baseline at 8 weeks
measure: Clinical Global Impression-severity, Clinical Global Impression-Improvement
timeFrame: Change from Baseline at 8 weeks
measure: Beck Depression Inventory
timeFrame: Change from Baseline at 8 weeks
measure: Inventory of Depressive Symptomatology Self-Report Scale
timeFrame: Change from Baseline at 8 weeks
measure: Drug - Induced Extrapyramidal Symptoms Scale
timeFrame: Change from Baseline at 8 weeks
measure: The Liverpool University Neuroleptic Side Effect Rating Scale
timeFrame: Change from Baseline at 8 weeks
measure: Short From-36 Health survey
timeFrame: Change from Baseline at 8 weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Yong Min Ahn, MD. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: