Escitalopram (Lexapro®) In Patients With Major Depression With Atypical Features

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Aims of Study:

The aims of this study are 1) to examine the clinical utility of escitalopram in patients with major depression with atypical features; 2) to evaluate the tolerability of escitalopram in major depression with atypical features.

Study hypothesis and objectives. This study is proposed as an open-label study to gather pilot data to examine whether escitalopram has clinical utility in the treatment of major depression with atypical features. Because of the exploratory nature of the design, no specific study hypotheses can be generated regarding efficacy of the drug. Our primary hypothesis is that the effect size of escitalopram in atypical depression will be similar to the effect size of escitalopram in major depression, its FDA approved indication.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: Forest Laboratories
• Treatments: Citalopram; Dexetimide

Criteria

Inclusion Criteria:

1. age 18 to 65 years,

2. DSM-IV episode of Major Depression non-psychotic with atypical features.

3. ≥19 score on the 29-item HAM-D,

4. ability to give informed consent, if patients are of child-bearing potential

5. A minimum 2-week washout from existing psychotropics (5 weeks for fluoxetine).

Exclusion Criteria:

1. bipolar depression,

2. Any Axis I psychotic disorder

3. currently suicidal or suicide risk,

4. history of substance abuse in the previous 12 months,

5. history of hypersensitivity to escitalopram, or citalopram

6. serious or unstable medical disorders,

7. starting or terminating psychotherapy during the previous 12 weeks,

8. ECT treatment in the previous 3 months,

9. pregnancy or planning pregnancy.