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Evaluation of Depression Symptoms and Brain Activity Associated With Response to Treatment of Depression

This study has suspended participant recruitment.
Sponsor:
Collaborators:
Eli Lilly and Company
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00200902
First received: September 14, 2005
Last updated: November 19, 2009
Last verified: November 2009

September 14, 2005
November 19, 2009
August 2005
June 2009   (final data collection date for primary outcome measure)
Depressive symptoms; measured throughout the study [ Time Frame: Baseline visit, end-of-lead in, 48 hour post tx assignment, week 1, week 2, week 4, week 8 ] [ Designated as safety issue: No ]
Depressive symptoms; measured throughout the study
Complete list of historical versions of study NCT00200902 on ClinicalTrials.gov Archive Site
Brain electrical activity; measured throughout the study [ Time Frame: Baseline visit, end-of-lead in, 48 hour post tx assignment, week 1, week 2, week 4, week 8 ] [ Designated as safety issue: No ]
Brain electrical activity; measured throughout the study
Not Provided
Not Provided
 
Evaluation of Depression Symptoms and Brain Activity Associated With Response to Treatment of Depression
Factors of Treatment Response in Major Depressive Disorder

This study will use measurements of depression symptoms and brain activity to determine what factors may influence an individual's response to treatment for depression.

We are using depression symptom measurements and measurements of brain electrical activity (EEG) to determine what factors may influence whether a patient is likely to show a response to antidepressant medication, placebo, or only clinical visits (without the use of pills) during a treatment trial for depression.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Depression
  • Drug: venlafaxine (Effexor)
    Subjects assigned to the placebo (PBO) or medication (MED) condition will enter double-blind treatment with either venlafaxine XR, duloxetine, escitalopram, or placebo after lead-in. They will undergo the same schedule, structure, and intensity of visits as in the ICI condition, but also will be randomized to receive treatment with a pill. Subjects randomized to medication will be started on one tablet each morning of either venlafaxine XR 75 mg., duloxetine 30 mg., or escitalopram 10 mg. Dosages will be increased in a double-blinded manner by increasing the number of pills administered by one pill every three to five days until the final dose is achieved (225 mg., 90 mg., and 30 mg. respectively for venlafaxine XR, duloxetine, and escitalopram). In order to maintain blinding during dosage increase, the number of tablets of placebo will be increased every three to five days as well.
  • Drug: duloxetine (Cymbalta)
    Subjects assigned to the placebo (PBO) or medication (MED) condition will enter double-blind treatment with either venlafaxine XR, duloxetine, escitalopram, or placebo after lead-in. They will undergo the same schedule, structure, and intensity of visits as in the ICI condition, but also will be randomized to receive treatment with a pill. Subjects randomized to medication will be started on one tablet each morning of either venlafaxine XR 75 mg., duloxetine 30 mg., or escitalopram 10 mg. Dosages will be increased in a double-blinded manner by increasing the number of pills administered by one pill every three to five days until the final dose is achieved (225 mg., 90 mg., and 30 mg. respectively for venlafaxine XR, duloxetine, and escitalopram). In order to maintain blinding during dosage increase, the number of tablets of placebo will be increased every three to five days as well.
  • Drug: escitalopram (Lexapro)
    Subjects assigned to the placebo (PBO) or medication (MED) condition will enter double-blind treatment with either venlafaxine XR, duloxetine, escitalopram, or placebo after lead-in. They will undergo the same schedule, structure, and intensity of visits as in the ICI condition, but also will be randomized to receive treatment with a pill. Subjects randomized to medication will be started on one tablet each morning of either venlafaxine XR 75 mg., duloxetine 30 mg., or escitalopram 10 mg. Dosages will be increased in a double-blinded manner by increasing the number of pills administered by one pill every three to five days until the final dose is achieved (225 mg., 90 mg., and 30 mg. respectively for venlafaxine XR, duloxetine, and escitalopram). In order to maintain blinding during dosage increase, the number of tablets of placebo will be increased every three to five days as well.
  • Other: placebo
    Subjects assigned to the placebo (PBO) or medication (MED) condition will enter double-blind treatment with either venlafaxine XR, duloxetine, escitalopram, or placebo after lead-in. They will undergo the same schedule, structure, and intensity of visits as in the ICI condition, but also will be randomized to receive treatment with a pill. Subjects randomized to medication will be started on one tablet each morning of either venlafaxine XR 75 mg., duloxetine 30 mg., or escitalopram 10 mg. Dosages will be increased in a double-blinded manner by increasing the number of pills administered by one pill every three to five days until the final dose is achieved (225 mg., 90 mg., and 30 mg. respectively for venlafaxine XR, duloxetine, and escitalopram). In order to maintain blinding during dosage increase, the number of tablets of placebo will be increased every three to five days as well.
  • Active Comparator: 1
    venlafaxine XR
    Intervention: Drug: venlafaxine (Effexor)
  • Active Comparator: 2
    duloxetine (Cymbalta)
    Intervention: Drug: duloxetine (Cymbalta)
  • Active Comparator: 3
    escitalopram (Lexapro)
    Intervention: Drug: escitalopram (Lexapro)
  • Placebo Comparator: placebo
    Intervention: Other: placebo
  • No Intervention: ICI
    Subjects assigned to the interpersonal clinical interaction (ICI) will undergo a one-week waiting period after the initial assessment. Visits will involve a session with a research nurse that will be approximately 20 minutes in length; visits at baseline, end of lead-in, and 1, 2, 4, and 8 weeks also will include a brief (5-10 minutes) meeting with a physician.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
140
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of unipolar major depression

Exclusion Criteria:

  • Substance abuse
  • Psychotic disorder
  • History of severe head trauma
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00200902
R01 AT002479-02, R01AT002479-02, 04-02-068
Yes
Andrew F. Leuchter, MD, University of California Los Angeles
University of California, Los Angeles
  • National Center for Complementary and Alternative Medicine (NCCAM)
  • Eli Lilly and Company
  • Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Andrew F. Leuchter, MD University of California, Los Angeles
University of California, Los Angeles
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP