NCT00215176

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

June 19, 2013

Status Verified

September 1, 2005

First QC Date

September 20, 2005

Last Update Submit

June 17, 2013

Conditions

Atypical Depression

Keywords

atypical depressionpsychostimulantsmodafinil

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (8)

  • 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)

  • +3 more secondary outcomes

Interventions

modafinilDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Modafinil

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Jonathan Davidson, M.D.

    Duke Univeristy Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

February 1, 2003

Study Completion

April 1, 2005

Last Updated

June 19, 2013

Record last verified: 2005-09