Status:
COMPLETED
Study of the Effects of an Antidepressant Medication and Placebo on the Brain Functioning of Normal Subjects
Lead Sponsor:
University of California, Los Angeles
Conditions:
Depression
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
Major Depressive Disorder (MDD) is a lifelong and recurrent illness, such that many individuals require multiple courses of antidepressant medication treatment. While some patients respond completely ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00634283
Start Date
February 1 2008
End Date
February 1 2009
Last Update
March 9 2020
Active Locations (1)
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1
University of California Los Angeles (UCLA)
Los Angeles, California, United States, 90024