search
Back to results

Modafinil for Atypical Depression

Primary Purpose

Atypical Depression

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
modafinil
Sponsored by
Duke University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atypical Depression focused on measuring atypical depression, psychostimulants, modafinil

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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)

    Full Information

    First Posted
    September 20, 2005
    Last Updated
    June 17, 2013
    Sponsor
    Duke University
    Collaborators
    Cephalon
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00215176
    Brief Title
    Modafinil for Atypical Depression
    Official Title
    A Study of Modafinil for Atypical Depression
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    April 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Duke University
    Collaborators
    Cephalon

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atypical Depression
    Keywords
    atypical depression, psychostimulants, modafinil

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    65 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    modafinil
    Primary Outcome Measure Information:
    Title
    HAM-D-29 (Hamilton Depression 29-Item Scale, with Atypical Features)
    Secondary Outcome Measure Information:
    Title
    ADDS (Atypical Depression Diagnostic Scale)
    Title
    CGI-S (Clinical Global Impressions Severity Scale)
    Title
    CGI-I (Clinical Global Impressions Improvement Scale)
    Title
    SCL-90 (Symptom Checklist 90)
    Title
    ESS (Epworth Sleepiness Scale)
    Title
    BFI (Brief Fatigue Inventory)
    Title
    FSS (Fatigue Severity Scale)
    Title
    SOS (Severity of Symptoms Scale)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jonathan Davidson, M.D.
    Organizational Affiliation
    Duke Univeristy Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Modafinil for Atypical Depression

    We'll reach out to this number within 24 hrs