Modafinil for Atypical Depression

Atypical Depression Clinical Trial

Official title:

A Study of Modafinil for Atypical Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00215176
• Other study ID #: 4428
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 20, 2005
• Last updated: June 17, 2013
• Start date: February 2003
• Est. completion date: April 2005

Study information

• Verified date: September 2005
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Atypical Depression
• Depression
• Depressive Disorder

Intervention

Drug:
• modafinil

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Cephalon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HAM-D-29 (Hamilton Depression 29-Item Scale, with Atypical Features)
Secondary	ADDS (Atypical Depression Diagnostic Scale)
Secondary	CGI-S (Clinical Global Impressions Severity Scale)
Secondary	CGI-I (Clinical Global Impressions Improvement Scale)
Secondary	SCL-90 (Symptom Checklist 90)
Secondary	ESS (Epworth Sleepiness Scale)
Secondary	BFI (Brief Fatigue Inventory)
Secondary	FSS (Fatigue Severity Scale)
Secondary	SOS (Severity of Symptoms Scale)