Modafinil for Atypical Depression - Full Text View

Sponsors and Collaborators:	Duke University Cephalon
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00215176

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 II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study of Modafinil for Atypical Depression

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Modafinil

U.S. FDA Resources

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

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

Study ID Numbers:	4438-03-IR0
Study First Received:	September 20, 2005
Last Updated:	December 18, 2006
ClinicalTrials.gov Identifier:	NCT00215176 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Duke University:

atypical depression
psychostimulants
modafinil

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders
Central Nervous System Stimulants

Depressive Disorder
Neuroprotective Agents
Modafinil
Behavioral Symptoms

Additional relevant MeSH terms:

Depression
Physiological Effects of Drugs
Central Nervous System Stimulants
Depressive Disorder
Neuroprotective Agents
Protective Agents
Modafinil

Pharmacologic Actions
Behavioral Symptoms
Mental Disorders
Therapeutic Uses
Mood Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009