Atypical Depression Clinical Trial
Official title:
A Pilot Study -- An Open-Label, Rater-blinded, Flexible-dose, 8-week Trial of Escitalopram (Lexapro®) In Patients With Major Depression With Atypical Features.
Verified date | January 2008 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | May 2007 |
Est. primary completion date | May 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Dept Psychiatry, Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | Forest Laboratories |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | changes in HAM-D-29 scores from baseline to end of treatment. | 8 weeks | No | |
Secondary | changes in 8-atypical items on the HAM-D-29, SDS and ESQ from baseline to end of treatment. Response will be defined as 50% or greater reduction in HAM-D-29 scores from baseline to end of treatment. | 8 weeks | No |
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