Modafinil for Atypical Depression

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: Cephalon
• Treatments: Armodafinil; Modafinil

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