Major Depressive Disorder Clinical Trial
— LillyOfficial title:
Neurophysiologic Monitoring of Antidepressant Treatment
The overall goal of this proposal is to study quantitative electroencephalography (QEEG ) as a method for the detection of antidepressant treatment response. The investigators have developed a QEEG algorithm called "cordance" that appears to provide much the same information about brain function as PET or SPECT scanning, and has shown patterns of brain function that appear to be indicative of depression. Of greatest interest is that these patterns appear to normalize in response to antidepressant treatment.
Status | Completed |
Enrollment | 24 |
Est. completion date | August 1996 |
Est. primary completion date | August 1996 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - All subjects will meet DSM-IV criteria for major depression based upon the Structured Clinical Interview for DSM-IV - Patient Version (SCID-P) (First et al., 1994). All research personnel have undergone SCID-P training, and soon will extend this training to the DSM-IV version. - Subjects also will have a score on the 17-item Hamilton Depression Rating Scale of > 18 (with item #1 > 2). - All subjects will be under the care of a clinician not affiliated with the study at the time of entry into the study, and through the course of the study. Exclusion Criteria: - Subjects will have no serious medical illness. - We 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, as will patients who previously have failed to respond to an adequate clinical trial of fluoxetine, or have failed to tolerate the medication. - Subjects who have had suboptimal trials, however, may still be considered for the study. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Hamilton Rating Scale For Depression Score | We will determine which subjects demonstrate improvement on the primary outcome measure (Ham-D) obtained the day of the EEG, and enter these as categorical variables (improved/not improved). | baseline, end of placebo-lead-in; and 48 hours, 1 week, 2 weeks, 4 weeks, and 8 weeks after randomized treatment | No |
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