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 range

18 Years – 65 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Major Depression trials