Major Depressive Disorder
Conditions
Keywords
Major depressive disorder, remission, escitalopram
Brief summary
The purpose of this study is the evaluation of remission rate between escitalopram 20 mg and 30 mg in patients with major depressive disorder.
Detailed description
In this study, the investigators are going to examine the efficacy of escitalopram after dose escalation and evaluate remission rate. This study design is the double-blinded 6-week prospective study. It would be useful for clinicians because there were few study of high-dose antidepressant treatment in lack of remission in major depressive disorder patients. To control of bias, the investigators included patients with lack of remission after 4-week escitalopram treatment.
Interventions
DRUGescitalopram
escitalopram 20mg and 30mg p.o. daily, 6 weeks
Sponsors
H. Lundbeck A/S
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18 \ 65 * Patient with major depressive disorder according to DSM-IV criteria * Patient have signed on the informed consent, and well understood the objective and procedure of this study. * MADRS total score ≥ 18 * Competent patient who is manage to answer the questionnaires. * In case of female at child-bearing age, consent to use appropriate contraceptive methods(oral pill, contraceptive injection, intrauterine device, double barrier method and contraceptive patch) during entire duration of this study.
Exclusion criteria
* In previous depressive episodes, no efficacy although more than one antidepressant treatment * Allergy or hypersensitivity to escitalopram * Diagnosed to schizophrenia or bipolar disorder or schizoaffective disorder (DSM-IV) * MADRS 10 score ≥ 5, or patient who is supposed to be impossible to participate to this study due to clinical risk of suicide or aggressive behavior based on clinician's opinion * Pregnant or breast-feeding female patient * Significant biochemical or hematological abnormality or abnormal finding of urinalysis, based on clinician's opinion * Significant severe medical condition * Patients who take antipsychotics or mood stabilizer or other psychiatric drugs excluding benzodiazepines or beta blockers or hypnotics * History of participating to other investigational drug trial within 1month prior to screening * Investigator or employee at clinical trial center, personnel related to investigator or trial center on this or other study, or family of employee or investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montgomery-Åsberg Depression Rating Scale (MADRS) | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Rating Scale (HAM-A) | 6 weeks |
| Clinical Global Impression-severity (CGI-S) | 6 weeks |
| Clinical Global Impression-Improvement (CGI-I) | 6 weeks |
| Hamilton Depression Rating Scale-17 items (HAM-D) | 6 weeks |
| WHO Quality Of Life scale Abbreviated Version(WHOQOL-BREF) | 6 weeks |
| Clinically Useful Depression Outcome Scale (CUDOS) | 6 weeks |
| Short From-36 Health survey (SF-36 Health survey) | 6 weeks |
| Beck's Depression Inventory(BDI) | 6 weeks |
Countries
South Korea
Outcome results
None listed