CompletedPhase 4

Physiologic Monitoring of Antidepressant Response

United States38 participantsStarted 1996-11

Plain-language summary

Primary: 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; Secondary: to determine if cordance changes early in the course (i.e., prior to improvement in clinical symptoms) of venlafaxine (or another antidepressant if venlafaxine is not clinically indicated for a particular patient) are predictive of later clinical response.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All subjects will meet DSM-IV criteria for depression on the basis of a SCID-P interview, with subjects in the placebo controlled phase of the study having a score on the 17-item Ham-D \> 18 (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 * 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 placebo-controlled phase of the study.

What they're measuring

quantitative electroencephalography (QEEG)

Timeframe: 6 QEEG measurements (end of wash-in, and 48 hours, 1 week, 2 weeks, 4 weeks, and 8 weeks after randomized treatment)

Trial details

NCT IDNCT00792168

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion1996-11