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Physiologic Monitoring of Antidepressant Treatment Response

NCT00759317 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2014-07-03

No results posted yet for this study

Summary

Study Objectives:

* to identify neurophysiologic effects of venlafaxine treatment in normal controls using quantitative EEG (QEEG) cordance
* to examine the effects of venlafaxine on different rating scales measuring mood and anxiety (e.g., Ham-D, BDI, SCL-90, POMS-BI, Visual Analog Mood Scale, SSRS, SASS, Q-LES-Q and SF-36) as well as on measures of cognitive and psychosocial function (i.e., Stroop, PASAT, RAVLT, Trailmaking A and B, Digit-Symbol, Grooved Pegboard, Multidimensional Health Locus of Control, Temperament and Character Inventory, Interpersonal Support Evaluation List, Godin Leisure-Time Questionnaire, and Pittsburgh Sleep Quality Index) in normal control subjects, and the association of changes in cordance with changes in thinking and memory.
* to identify physiologic effects of venlafaxine treatment in normal controls using heart rate and immune function measures

Conditions

Interventions

DRUG

venlafaxine (Effexor)

Matching capsules containing either 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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-06-30
Primary Completion
2002-08-31
Completion
2002-09-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00759317 on ClinicalTrials.gov