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

Institute for Neurodegenerative Disorders

Status and phase

Terminated

Phase 1

Conditions

Depression

Treatments

Drug: 123-I MZINT injection and SPECT imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT00470925

mZINT_003

Details and patient eligibility

About

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.

Full 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. 5-HT neurons project diffusely throughout the brain, innervating the cerebral cortex, hippocampus, thalamus, midbrain, brainstem and cerebellum, and play a prominent role in regulating physiological and behavioral responses such as arousal, thermoregulation, anxiety, and affect.

All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, and a baseline physical and neurological evaluation. healthy subjects will undergo a baseline 123-I MZINT injection and SPECT imaging described below. At baseline, healthy subjects will be started on either no treatment (n=4), or one of three different doses of sertraline (25 mg/day n=2, 50 mg/day n=2 or 150 mg/day n=2), which will be administered over a 14 day period. Fourteen days following imaging session 1, all subjects (treated with sertraline and untreated) will undergo a second 123-I MZINT and SPECT imaging study. Data from the baseline and follow-up SPECT images will be compared to evaluate for any effect of sertraline on regional brain uptake of 123-I MZINT. The subjects that are randomized to no treatment will serve as controls and provide preliminary test-retest reproducibility data on the imaging outcome measure.

The goal of this proposal is to evaluate the effect of sertraline administration on the specific [123-I] mZINT. In vitro and in vivo data from early human studies and baboon studies strongly support further evaluation of [123I] mZINT in healthy subjects.

Enrollment

30 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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