Modafinil for Atypical Depression
Information source: Duke University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atypical Depression
Intervention: modafinil (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Duke University Official(s) and/or principal investigator(s):
Jonathan Davidson, M.D., Principal Investigator, Affiliation: Duke Univeristy Medical Center
Summary
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.
Clinical Details
Official title: A Study of Modafinil for Atypical Depression
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: HAM-D-29 (Hamilton Depression 29-Item Scale, with Atypical Features)
Secondary outcome: ADDS (Atypical Depression Diagnostic Scale)CGI-S (Clinical Global Impressions Severity Scale) CGI-I (Clinical Global Impressions Improvement Scale) SCL-90 (Symptom Checklist 90) ESS (Epworth Sleepiness Scale) BFI (Brief Fatigue Inventory) FSS (Fatigue Severity Scale) SOS (Severity of Symptoms Scale)
Detailed description:
This study on the safety and efficacy of modafinil on atypical depression has an initial
12-week open label treatment period with modafinil that is followed by a 12-week
double-blind, randomized parallel treatment period with either modafinil or matching placebo.
Patients who demonstrate at least minimal improvement after 12 weeks are randomly assigned
to either continuing treatment at their current dose or switched to matching placebo for 12
weeks.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: February 2003
Ending date: April 2005
Last updated: December 18, 2006
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