Physiologic Monitoring of Antidepressant Response

NCT00792168 | Completed Phase 4

• 1 other identifier: 96-06-291
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depression

Outcome Measures

Primary Outcomes (1)

• quantitative electroencephalography (QEEG)

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

Secondary Outcomes (1)

• Clinical assessment measuresments: Ham-D, MADRS, Ham-A, SCL-90, Beck, LIFE, and CGI)

  6 study visits: end of wash-in, and 48 hours, 1 week, 2 weeks, 4 weeks, and 8 weeks after randomized treatment

Study Arms (2)

1. Venlafaxine

ACTIVE COMPARATOR

Drug: venlafaxine (Effexor)

2. Placebo

PLACEBO COMPARATOR

Other: placebo

Interventions

placebo OTHER

venlafaxine 37.5 mg. or placebo will be prepared by the UCLA Pharmacy for the initial phase of the study. For the open-label phase of the study, subjects will receive the medication and dosage that is clinically indicated by the subject's primary physician in the community. After a one-week placebo lead-in, subjects will be randomly assigned to receive one capsule of either venlafaxine or placebo, with the dosage increase every two days until subjects receive four capsules daily (subjects will achieve a dose 150 mg. of venlafaxine after 7 days). The first dose will be administered in the morning, with subsequent capsules added on a b.i.d. schedule

2. Placebo

venlafaxine (Effexor) DRUG

venlafaxine 37.5 mg. or placebo will be prepared by the UCLA Pharmacy for the initial phase of the study. For the open-label phase of the study, subjects will receive the medication and dosage that is clinically indicated by the subject's primary physician in the community. After a one-week placebo lead-in, subjects will be randomly assigned to receive one capsule of either venlafaxine or placebo, with the dosage increase every two days until subjects receive four capsules daily (subjects will achieve a dose 150 mg. of venlafaxine after 7 days). The first dose will be administered in the morning, with subsequent capsules added on a b.i.d. schedule

1. Venlafaxine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Study Officials

• Andrew F Leuchter, MDe

  UCLA Department of Psychiatry and Biobeavioral Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2008
• First Posted: November 17, 2008
• Study Start: November 1, 1996
• Primary Completion: November 1, 1996
• Study Completion: December 1, 1998
• Last Updated: December 22, 2025

Record last verified: 2008-11

Locations

US (1)