Physiologic Monitoring of Antidepressant Treatment Response

• Status: Completed
• Trial end date: 1998-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Treatments: Antidepressive Agents; Venlafaxine Hydrochloride

Criteria

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.