Expired Study
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Los Angeles, California 90024


Purpose:

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.


Criteria:

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


Study is Available At:


Original ID:

07-10-051


NCT ID:

NCT00634283


Secondary ID:

07-10-051


Study Acronym:


Brief Title:

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


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, Los Angeles


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Intervention Model:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

7


Enrollment Type:

Actual


Overall Contact Information

Official Name:Andrew Leuchter, MD
Principal Investigator
University of California, Los Angeles

Study Dates

Start Date:February 2008
Completion Date:February 2009
Completion Type:Actual
Primary Completion Date:February 2009
Primary Completion Type:Actual
Verification Date:August 2009
Last Changed Date:August 6, 2009
First Received Date:March 6, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Whether short-term antidepressant exposure results in long-term changes in resting brain function, as measured using QEEG cordance.
Time Frame:Five weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:venlafaxine
Description:venlafaxine IR 150mg
Arm Name:1
Other Name:Effexor

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:Five weeks of treatment with venlafaxine IR

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, Los Angeles

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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