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Modafinil for Atypical Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00215176
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : June 19, 2013
Sponsor:
Collaborator:
Cephalon
Information provided by:
Duke University

Tracking Information
First Submitted Date  ICMJE September 20, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date June 19, 2013
Study Start Date  ICMJE February 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2005)
HAM-D-29 (Hamilton Depression 29-Item Scale, with Atypical Features)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2005)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Modafinil for Atypical Depression
Official Title  ICMJE A Study of Modafinil for Atypical Depression
Brief 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Atypical Depression
Intervention  ICMJE Drug: modafinil
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 20, 2005)
65
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE April 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00215176
Other Study ID Numbers  ICMJE 4428
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Cephalon
Investigators  ICMJE
Principal Investigator: Jonathan Davidson, M.D. Duke Univeristy Medical Center
PRS Account Duke University
Verification Date September 2005

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