Atypical Depression Clinical Trial
Official title:
A Study of Modafinil for Atypical Depression
Verified date | September 2005 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purposes of the study are to: 1) evaluate the short-term efficacy and safety of modafinil in atypical depression; and 2) to evaluate the efficacy of modafinil in preventing relapse of atypical depression. The hypothesis is that modafinil is safe and effective in the treatment of atypical depression.
Status | Completed |
Enrollment | 65 |
Est. completion date | April 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - adults 18-65 years of age - DSM-IV criteria for major depressive episode with atypical features as assessed by the Atypical Depression Diagnostic Scale - minimum score of 18 on the Hamilton Depression Scale (29-item version) at baseline - baseline Clinical Global Impressions Severity score of 4 or more - written informed consent - negative serum pregnancy test for women of childbearing potential Exclusion Criteria: - any current primary DSM-IV Axis I disorder other than depression - history of DSM-IV diagnosis of bipolar I disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder, or cognitive disorder due to a general medical condition - history of substance abuse or dependence within the last 3 months - suicide risk or serious suicide attempt with the last year - clinically significant medical condition or laboratory or EKG abnormality - history of non-response to three prior adequate trials of antidepressants - women of childbearing potential who are unwilling to practice an acceptable method of contraception - history of hypersensitivity to modafinil - use of an investigational medication within the last 28 days - use of antidepressant medication with 28 days of screening |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Duke University | Cephalon |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HAM-D-29 (Hamilton Depression 29-Item Scale, with Atypical Features) | |||
Secondary | ADDS (Atypical Depression Diagnostic Scale) | |||
Secondary | CGI-S (Clinical Global Impressions Severity Scale) | |||
Secondary | CGI-I (Clinical Global Impressions Improvement Scale) | |||
Secondary | SCL-90 (Symptom Checklist 90) | |||
Secondary | ESS (Epworth Sleepiness Scale) | |||
Secondary | BFI (Brief Fatigue Inventory) | |||
Secondary | FSS (Fatigue Severity Scale) | |||
Secondary | SOS (Severity of Symptoms Scale) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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