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Modafinil for Atypical Depression

This study has been completed.
Sponsor:
Collaborator:
Cephalon
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00215176
First received: September 20, 2005
Last updated: June 17, 2013
Last verified: September 2005

September 20, 2005
June 17, 2013
February 2003
Not Provided
HAM-D-29 (Hamilton Depression 29-Item Scale, with Atypical Features)
Same as current
Complete list of historical versions of study NCT00215176 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Modafinil for Atypical Depression
A Study of Modafinil for Atypical Depression

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Atypical Depression
Drug: modafinil
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
April 2005
Not Provided

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00215176
4428
Not Provided
Not Provided
Duke University
Cephalon
Principal Investigator: Jonathan Davidson, M.D. Duke Univeristy Medical Center
Duke University
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP