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Study of the Effects of an Antidepressant Medication and Placebo on the Brain Functioning of Normal Subjects

Information source: University of California, Los Angeles
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depression

Intervention: venlafaxine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of California, Los Angeles

Official(s) and/or principal investigator(s):
Andrew Leuchter, MD, Principal Investigator, Affiliation: University of California, Los Angeles


This study examines the effects of an antidepressant medication and placebo on the brain functioning of normal subjects. In this study, recordings of brain electrical activity are being used to detect and monitor the response to treatment with venlafaxine IR (Effexor), a drug used for the treatment of depression. The intent of this study is to test specific hypotheses regarding: 1. long-term brain effects of a single course of antidepressant treatment 2. pharmaco-conditioning effects underlying antidepressant tolerance/sensitization 3. brain functional response to initial versus subsequent antidepressant trials in normal healthy subjects.

Clinical Details

Official title: Physiologic Monitoring of Antidepressant Medication Effects in Normal Healthy Subjects II

Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver)

Primary outcome: Whether short-term antidepressant exposure results in long-term changes in resting brain function, as measured using QEEG cordance.


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


Inclusion Criteria:

- Subject age is 18-75 years

- Subject must be in overall good health (i. e., free of any medical condition known to

affect brain function).

- Subject must have participated in former study, Physiologic Monitoring of

Antidepressant Medication Effects in Normal Controls Subjects (IRB#: 00-11-038-13)

- Subject has had a normal physical exam within one year prior to entry of the study

- Capacity to give Informed Consent

Exclusion Criteria:

- Subject has serious medical illness, such as high blood pressure, heart disease,

renal impairment, or cirrhosis of the liver.

- Subject meets DSM-IV Axis I criteria for a mood, anxiety, cognitive, or psychiatric

disorder; or meets criteria for cluster A or B axis II diagnoses. These disorders will be determined on the basis of a structured assessment with the MINI (Mini International Neuropsychiatric Interview for DSM-IV Axis I Disorders)

- Subject has a history of current or past active suicidal ideation or suicide


- Subject has received treatment with an antidepressant medication or any medications

that could influence brain function since his/her participation in the initial study

- Subject is using any of the following medications which interfere with EEG measures

of brain function: Anticholinergics, Barbiturates, Benzodiazepines, Sedating Antihistamines (e. g. diphenhydramine (Benadryl) would be exclusionary, but not loratadine (Claritin))

- Subject has a history of seizures, brain surgery, skull fracture, significant head

trauma, or previous abnormal EEG

- Subject is pregnant or planning on becoming pregnancy during course of the study

- Subject is a UCLA student or staff member directly under instruction or employment of

any of the investigators

Locations and Contacts

University of California Los Angeles (UCLA), Los Angeles, California 90024, United States
Additional Information

Starting date: February 2008
Last updated: August 6, 2009

Page last updated: August 23, 2015

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