Status:
TERMINATED
Assessment of the Effect of Sertaline on the Specific Binding of 123-I MZINT in Healthy Subjects
Lead Sponsor:
Institute for Neurodegenerative Disorders
Collaborating Sponsors:
Molecular NeuroImaging
Conditions:
Depression
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The overall purpose of this project is to evaluate the effect of sertraline administration on the binding of 123-I mZINT in 10 healthy subjects. All study procedures will be conducted at the Institute...
Detailed Description
Serotonin (5-HT) is a monoamine neurotransmitter found in the peripheral and central nervous system. It is responsible for regulating a wide variety of physiological processes and higher CNS functions...
Eligibility Criteria
Inclusion
- The subject is aged 18-70.
- Written informed consent is obtained.
- The participant has no clinically significant clinical laboratory value and/or clinically significant unstable medical, neurological or psychiatric illness.
- For females, non-child bearing potential or negative urine pregnancy test on day of \[123I\] mZINT injection.
- Willingness to comply with the study protocol
Exclusion
- The subject has a clinically significant clinical laboratory values abnormality, and/or medical or psychiatric illness.
- The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).
- The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- Use of all prescription drugs or non-prescriptions drugs that may effect serotonin such as antidepressants including sertraline, fluoxetine, fluvoxamine, venlafaxine within 60 days of baseline imaging study.
- The participant has a history of alcohol, narcotic, or any other drug abuse as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, 4th Edition (DSM IV) {American Psychiatric Association, 1994 #2} within the past 2 years.
- Pregnancy
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00470925
Start Date
May 1 2007
End Date
February 1 2008
Last Update
April 3 2019
Active Locations (1)
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1
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510