Major Depressive Disorder
Conditions
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.
Interventions
DRUGAripiprazole 6-week group
DRUGAripiprazole 8-week group
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Scale (QOLS) | Change from Baseline at 8 weeks | change of Quality of Life Scale (QOLS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Åsberg Depression Rating Scale | Change from Baseline at 8 weeks | change of Montgomery-Åsberg Depression Rating Scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory | Change from Baseline at 8 weeks | change of Beck Depression Inventory |
| Inventory of Depressive Symptomatology Self-Report Scale | Change from Baseline at 8 weeks | change of Inventory of Depressive Symptomatology Self-Report Scale |
| Hamilton Rating Scale for Depression | Change from Baseline at 8 weeks | change of Hamilton Rating Scale for Depression |
| The Liverpool University Neuroleptic Side Effect Rating Scale | Change from Baseline at 8 weeks | change of The Liverpool University Neuroleptic Side Effect Rating Scale |
| Short From-36 Health survey | Change from Baseline at 8 weeks | change of Short From-36 Health survey |
| Drug - Induced Extrapyramidal Symptoms Scale | Change from Baseline at 8 weeks | change of Drug - Induced Extrapyramidal Symptoms Scale |
| Clinical Global Impression-severity, Clinical Global Impression-Improvement | Change from Baseline at 8 weeks | change of Clinical Global Impression-severity, Clinical Global Impression-Improvement |
Countries
South Korea
Outcome results
None listed