Major Depressive Disorder Clinical Trial
Official title:
Aripiprazole (Abilify®) as an Adjunctive Treatment for Inadequate Response in Major Depressive Disorder
Verified date | April 2019 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | February 2019 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | Otsuka Pharmaceutical Co., Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Hamilton Rating Scale for Depression | change of Hamilton Rating Scale for Depression | Change from Baseline at 8 weeks | |
Other | Clinical Global Impression-severity, Clinical Global Impression-Improvement | change of Clinical Global Impression-severity, Clinical Global Impression-Improvement | Change from Baseline at 8 weeks | |
Other | Beck Depression Inventory | change of Beck Depression Inventory | Change from Baseline at 8 weeks | |
Other | Inventory of Depressive Symptomatology Self-Report Scale | change of Inventory of Depressive Symptomatology Self-Report Scale | Change from Baseline at 8 weeks | |
Other | Drug - Induced Extrapyramidal Symptoms Scale | change of Drug - Induced Extrapyramidal Symptoms Scale | Change from Baseline at 8 weeks | |
Other | The Liverpool University Neuroleptic Side Effect Rating Scale | change of The Liverpool University Neuroleptic Side Effect Rating Scale | Change from Baseline at 8 weeks | |
Other | Short From-36 Health survey | change of Short From-36 Health survey | Change from Baseline at 8 weeks | |
Primary | Quality of Life Scale (QOLS) | change of Quality of Life Scale (QOLS) | Change from Baseline at 8 weeks | |
Secondary | Montgomery-Åsberg Depression Rating Scale | change of Montgomery-Åsberg Depression Rating Scale | Change from Baseline at 8 weeks |
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