Developing New Clinical Management Strategies
Major Depressive Disorder
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- 1. men and women aged 18-60 years
- 2. diagnosis with Diagnostic and Statistical Manual (DSM) IV Major Depressive Disorder (MDD)
- 3. 24-item Hamilton Rating Scale for Depression (HRSD) score greater than or equal to 18
- 4. capable of providing informed consent and complying with study procedures
- 5. using appropriate contraceptive method if woman of child-bearing age
Exclusion Criteria:
- 1. Current comorbid Axis I DSM IV disorder other than Nicotine Dependence, Adjustment Disorder, or Anxiety Disorder
- 2. diagnosis of substance abuse or dependence (excluding Nicotine Dependence) within the past 12 months
- 3. present or past history of psychosis, psychotic disorder, mania, or bipolar disorder
- 4. baseline HRSD score > 28 or HRSD suicide item > 2
- 5. history of allergic or adverse reaction to escitalopram, or non-response to adequate trial of escitalopram (at least 4 weeks at dose of 20mg) during the current episode
- 6. current treatment with psychotherapy, antidepressants, antipsychotics, or mood stabilizers
- 7. CGI-Severity score of 7 at baseline
- 8. acute, severe, or unstable medical illness
Sites / Locations
- New York State Psychiatric Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Placebo Comparator
Active Comparator
Active Comparator
Clinical Frequency Management: Placebo
Research Frequency Management: Placebo
Clinical Frequency Management: Escitalopram
Research Frequency Management: Escitalopram
Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.
Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.
Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.
Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.