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: December 18, 2006

Last verified: September 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

September 20, 2005

Last Updated Date

December 18, 2006

Start Date ^ICMJE

February 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

HAM-D-29 (Hamilton Depression 29-Item Scale, with Atypical Features)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00215176 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Atypical Depression

Intervention ^ICMJE

Drug: modafinil

Study Arm (s)

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

Completion Date

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00215176

Other Study ID Numbers ^ICMJE

4438-03-IR0

Has Data Monitoring Committee

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

Information Provided By

Duke University

Verification Date

September 2005

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

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