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

NCT00470925 | Terminated Phase 1

• 1 other identifier: mZINT_003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Depression

Keywords

Neurological; Dopamine

Outcome Measures

Primary Outcomes (1)

• Does administration of sertraline have an effect on the specific binding of 123-mZINT in healthy subjects evaluated with serial, dynamic SPECT imaging at baseline and after 14 days of sertraline treatment?

  14 DAYS

Secondary Outcomes (1)

• Is there a dose effect of sertraline on 123I MZINT binding? Do higher doses of sertraline have a more profound effect on the specific binding of 123I MZINT than lower doses of sertraline?

  14 DAYS

Study Arms (1)

Access [123I]MZINT and SPECT Imaging

EXPERIMENTAL

Drug: 123-I MZINT injection and SPECT imaging

Interventions

123-I MZINT injection and SPECT imaging DRUG

SPECT imaging uses the single photon emissions from radioactive compounds that are (most commonly) injected into a patient and are metabolized by specific organs or body systems. SPECT imaging is performed by using a gamma camera to acquire multiple 2-D images (also called projections), from multiple angles. A computer is then used to apply a tomographic reconstruction algorithm to the multiple projections, yielding a 3-D dataset. This dataset may then be manipulated to show thin slices along any chosen axis of the body, similar to those obtained from other tomographic techniques, such as MRI, CT, and PET. The resulting SPECT images reflect body/organ function as opposed to specific anatomy of other imaging modalities such as CT or MRI

Access [123I]MZINT and SPECT Imaging

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Institute for Neurodegenerative Disorders: lead
• Molecular NeuroImaging: collaborator

Study Sites (1)

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

• Brooks DJ, Piccini P. Imaging in Parkinson's disease: the role of monoamines in behavior. Biol Psychiatry. 2006 May 15;59(10):908-18. doi: 10.1016/j.biopsych.2005.12.017. Epub 2006 Apr 11.

  PMID: 16581032 BACKGROUND

Related Links

• IND web page
• MNI web page

MeSH Terms

Conditions

Depression; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Danna L. Jennings, MD

  unafilliated

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2007
• First Posted: May 8, 2007
• Study Start: May 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: April 3, 2019

Record last verified: 2019-04

Locations

US (1)