Assessment of the Effect of Sertaline on the Specific Binding of 123-I MZINT in Healthy Subjects

Stopped early · Phase 1

Conditions studied: Depression

In brief

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 for Neurodegenerative Disorders (IND) and Molecular NeuroImaging (MNI) in New Haven, CT.

Key facts

Study ID

NCT00470925

Run by

Institute for Neurodegenerative Disorders

People needed

30

Starts

2007-05-01

Expected to finish

2008-02-01

Last updated by the study team

2019-04-03

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Institute for Neurodegenerative Disorders — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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