Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
Sponsor:
Collaborator:
Molecular NeuroImaging
Information provided by:
Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier:
NCT00470925
First received: May 4, 2007
Last updated: December 28, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Depression
Procedure: 123-I MZINT injection and SPECT imaging
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Assessment of the Effect of Sertaline on the Specific Binding of 123-I MZINT in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Institute for Neurodegenerative Disorders:

Primary Outcome Measures:
  • 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? [ Time Frame: 14 DAYS ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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? [ Time Frame: 14 DAYS ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: May 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Access [123I]MZINT and SPECT Imaging Procedure: 123-I MZINT injection and SPECT imaging
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

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. 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470925

Locations
United States, Connecticut
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Institute for Neurodegenerative Disorders
Molecular NeuroImaging
Investigators
Principal Investigator: Danna L. Jennings, MD unafilliated
  More Information

Additional Information:
Publications:
Responsible Party: John Seibyl, MD, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier: NCT00470925     History of Changes
Other Study ID Numbers: mZINT_003
Study First Received: May 4, 2007
Last Updated: December 28, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Institute for Neurodegenerative Disorders:
Neurological
Dopamine

Additional relevant MeSH terms:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on November 23, 2014