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
  Purpose

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.


Condition Intervention Phase
Atypical Depression
Drug: modafinil
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Study of Modafinil for Atypical Depression

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • HAM-D-29 (Hamilton Depression 29-Item Scale, with Atypical Features)

Secondary Outcome Measures:
  • 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)

Estimated Enrollment: 65
Study Start Date: February 2003
Estimated Study Completion Date: April 2005
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00215176

Sponsors and Collaborators
Duke University
Cephalon
Investigators
Principal Investigator: Jonathan Davidson, M.D. Duke Univeristy Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00215176     History of Changes
Other Study ID Numbers: 4428
Study First Received: September 20, 2005
Last Updated: June 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
atypical depression
psychostimulants
modafinil

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Modafinil
Armodafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014