NCT00759317

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_4 depression

Timeline
Completed

Started Jun 2001

Shorter than P25 for phase_4 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2002

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2002

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
Last Updated

July 3, 2014

Status Verified

July 1, 2014

Enrollment Period

1.2 years

First QC Date

September 24, 2008

Last Update Submit

July 1, 2014

Conditions

Depression

Keywords

normal controls

Study Arms (2)

1

ACTIVE COMPARATOR

venlafaxine

Drug: venlafaxine (Effexor)

2

PLACEBO COMPARATOR
Drug: venlafaxine (Effexor)

Interventions

venlafaxine (Effexor)DRUG

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.

12

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All subjects will be between the ages of 18 - 65 and in good health (i.e., free of any medical condition known to affect brain function).

You may not qualify if:

  • All subjects will have no serious medical illness such as high blood pressure, heart disease, renal impairment, or cirrhosis of the liver. This will be assured by making sure that prospective subjects have had a normal physical exam with in one year prior to entry of the study.
  • The investigators will also exclude subjects who meet DSM-IV axis I criteria for a mood, anxiety, cognitive, or psychotic disorder on the basis of a SCID-P interview, as well as those meeting criteria for cluster A or B axis II diagnoses.
  • Subjects with a history of current or past active suicidal ideation or suicide attempts will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Laboratory of Brain, Behavior, and Pharmacology

Los Angeles, California, 90024, United States

Location

Related Publications (2)

  • Hunter AM, Cook IA, Abrams M, Leuchter AF. Neurophysiologic effects of repeated exposure to antidepressant medication: are brain functional changes during antidepressant administration influenced by learning processes? Med Hypotheses. 2013 Dec;81(6):1004-11. doi: 10.1016/j.mehy.2013.09.016. Epub 2013 Sep 17.

    PMID: 24112999BACKGROUND

  • Leuchter AF, Cook IA, Hunter AM, Cai C, Horvath S. Resting-state quantitative electroencephalography reveals increased neurophysiologic connectivity in depression. PLoS One. 2012;7(2):e32508. doi: 10.1371/journal.pone.0032508. Epub 2012 Feb 24.

    PMID: 22384265RESULT

MeSH Terms

Conditions

Depression

Interventions

Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsPhenethylaminesEthylaminesAminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsLipids

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 24, 2008

First Posted

September 25, 2008

Study Start

June 1, 2001

Primary Completion

August 1, 2002

Study Completion

September 1, 2002

Last Updated

July 3, 2014

Record last verified: 2014-07

Locations

US(1)