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

Official Title: “Physiologic Monitoring of Antidepressant Medication Effects in Normal Healthy Subjects II”

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.

Intervention(s) in this Clinical Trial

• Drug: venlafaxine
  • venlafaxine IR 150mg

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Five weeks of treatment with venlafaxine IR

Primary Measures

• Whether short-term antidepressant exposure results in long-term changes in resting brain function, as measured using QEEG cordance.
  • Time Frame: Five weeks
    Safety Issue?: No

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 attempts.
• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: University of California, Los Angeles Other

Overall Clinical Trial Officials and Contacts

Andrew Leuchter, MD Principal Investigator University of California, Los Angeles  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00634283

Study ID Number: 07-10-051

ClinicalTrials.gov Identifier: NCT00634283

Health Authority: United States: Institutional Review Board