Major Depressive Disorder Clinical Trial
Official title:
EEG Biomarkers of Response in Depression
There are two specific aims of this project:
1. To identify physiologic indicators of venlafaxine treatment response using quantitative
EEG (QEEG) cordance, and to determine if cordance changes are specifically associated
with response to venlafaxine
2. To identify predictors of placebo response in major depression using QEEG
cordance/bispectral index (BIS) and neuropsychological testing
Status | Completed |
Enrollment | 44 |
Est. completion date | December 2005 |
Est. primary completion date | November 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - All subjects will meet DSM-IV criteria for depression on the basis of a SCID-P interview, with subjects having a score on the 17-item Ham-D > 17 (with item #1 > 2). - Subjects will meet criteria both at recruitment and after a one-week single blind placebo wash-in. Study includes outpatients only. Exclusion Criteria: - All subjects will have no serious medical illness. The investigators will exclude patients also meeting criteria for the following groups of axis I diagnoses: - delirium or dementia - substance-related disorders - schizophrenia or other psychotic disorders, or eating disorders. - In addition, patients meeting criteria for cluster A or B axis II diagnoses will be excluded. - Subjects with a history of current or past active suicidal ideation, or suicide attempts will be excluded from the study. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | UCLA Laboratory of Brain, Behavior, and Pharmacology | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles | Medtronic - MITG, Wyeth is now a wholly owned subsidiary of Pfizer |
United States,
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