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Modafinil for Atypical Depression

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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

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.

Condition or disease Intervention/treatment Phase
Atypical Depression Drug: modafinil Phase 2 Phase 3

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 : Interventional  (Clinical Trial)
Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Study of Modafinil for Atypical Depression
Study Start Date : February 2003
Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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

Secondary Outcome Measures :
  1. ADDS (Atypical Depression Diagnostic Scale)
  2. CGI-S (Clinical Global Impressions Severity Scale)
  3. CGI-I (Clinical Global Impressions Improvement Scale)
  4. SCL-90 (Symptom Checklist 90)
  5. ESS (Epworth Sleepiness Scale)
  6. BFI (Brief Fatigue Inventory)
  7. FSS (Fatigue Severity Scale)
  8. SOS (Severity of Symptoms Scale)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00215176


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

ClinicalTrials.gov Identifier: NCT00215176     History of Changes
Other Study ID Numbers: 4428
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: September 2005

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
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs