Major depression
Conditions
Interventions
Flexible dose (10-20mg/day) of escitalopram will be first administered for 8 weeks (Step 1), and responders will continue escitalopram and non-responders will be switched to duloxetine in the next ste
Sponsors
National Center of Neurology and Psychiatry
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Fulfill criteria for major depressive disorder, as defined by DSM-IV criteria for single or recurrent without psychotic features, as determined by clinical assessment by treating psychiatrist and confirmed by the Mini-International Neuropsychiatric Interview (M.I.N.I.). 2)Aged 20-75 years at screening. 3)Patients who have been treated with therapeutic dose of SSRI (sertraline, paroxetine or fluvoxamine) or SNRI (milnacipran) or NaSSA (mirtazapine) for at least 3 weeks. 4)Depression symptoms of at least moderate severity based on Clinical Global Impression of Severity (CGI-S) score >= 4. 5)Major depressive disorder is the primary diagnosis for the treatment and treating psychiatrist has judged study drug (i.e. escitalopram or duloxetine) to be appropriate for prescribing. 6)Competent and able to understand the meaning of the observation, evaluation and clinical examination in the judgment of the treating psychiatrist. 7)Competent and able to give their own informed consent. 8)Available on the phone for assessments.
Exclusion criteria
Exclusion criteria: 1)Did not respond to 2 or more adequate antidepressants (each for at least 4 weeks with therapeutic dose ) during current depressive episode judged by the treating physician. 2)Comorbid psychiatric condition (DSM-IV axis 1) other than major depressive disorder that is considered as the primary diagnosis within 1 year of screening. 3)History of bipolar disorder, schizophrenia, or other psychotic disorder at screening by the treating physician. 4)History of substance abuse/dependence within 1 year of screening, except caffeine and nicotine. 5)Have an Axis 2 disorder that, judged by treating physician, would interfere with compliance with the study protocol. 6)Did not respond to escitalopram or duloxetine on maximum dose for at least 4 weeks during the past depressive episode. 7)Women who are currently pregnant or breastfeeding. 8)Patients who are judged by the treating physician to be at serious risk for harm to self or others. 9)Patients who are judged by the treating physician to have serious and/or unstable illness including problems in liver, kidney, respiratory system, hematological, endocrine system, or CNS, or traumatic brain injury. 10)Have a serious or unstable cardiovascular illness (including severe arrhythmia with bradycardia, prescribed with drugs known to cause QTc prolongation, congestive heart failure, hypokalemia), or clinically significant ECG abnormality (male: QTc>450ms, female: QTc>470ms). 11)Ongoing treatment with MAO inhibitors within 2 weeks of cessation of treatment. 12)Have an uncontrolled closed-angle glaucoma. 13)Ongoing treatment with Pimozide (Orap). 14)Patients who were diagnosed as Dementia using DSM-4-TR. 15)Patients who are judged by the treating physician to be inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment discontinuation and/or dropout rate for any reason at 8-week period | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment discontinuation rate (early/late phase) Efficacy (symptom severity, response/remission rate) Health outcome (QOL, functioning) Safety (side effects, adverse events, ECG, laboratory data) | — |
Countries
Japan
Contacts
Public ContactYuma Yokoi
National Center of Neurology and Psychiatry Hospital First Division of Psychiatry
Outcome results
None listed