Modafinil for Atypical Depression

Duke University

Status and phase

Completed

Phase 3

Phase 2

Conditions

Atypical Depression

Treatments

Drug: modafinil

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00215176

4428

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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