PET Whole Body Distribution Studies Using [11C]CUMI

NCT01132872 | Completed

• 2 other identifiers: 10011010-M-0110
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Background:

• Researchers studying new treatments for major depressive disorder are looking at how medications to treat depression act on the brain chemical serotonin, which interacts with specific serotonin receptors on brain cells. New methods of studying serotonin receptors in the brain may help provide a better understanding of depression and treatment options.
• A new radioactive chemical called \[11C\]CUMI may be useful for studying serotonin receptors in the brain. By using positron emission tomography (PET) scanning to see how \[11C\]CUMI bonds with serotonin receptors, researchers will investigate whether \[11C\]CUMI can be used to study depression and how antidepressant medications work. Objectives: \- To determine the usefulness of \[11C\]CUMI as a method of studying serotonin receptors in the brain. Eligibility: \- Healthy individuals between 18 and 65 who have no history of psychiatric illness. Design:
• This study requires 8 outpatient visits to the NIH clinic.
• Visit 1: Participants will have a full physical examination and medical history, as well as a psychiatric evaluation and questions about alcohol and drug use. Other tests will include blood and urine samples and an electrocardiogram (EKG). Testing will take approximately 3 hours.
• Visit 2: Participants will have a magnetic resonance imaging (MRI) scan to evaluate brain function and activity.
• Visit 3: Participants will have a PET scan, in which a small amount of the radioactive chemical \[11C\]CUMI will be injected through an intravenous (IV) catheter, and will have another IV line put in place to draw regular blood samples during the scan. The scan will last approximately 4 hours.
• Visits 4-8: Participants will have regular blood tests after the scan between days 1-3 and at about weeks 1, 2, 3, and 4. The blood tests will check muscle, heart, and liver function.

Conditions

Depression; Major Depression; Unipolar Depression; Anxiety Disorder; Anxiety Disorders

Keywords

Serotonin 1A Receptor; Positron Emission Tomograhy (PET); Dosimetry; Healthy Volunteer; HV

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be adults between 18-65 years old.
• Subjects must be able and willing to give written informed consent.

You may not qualify if:

• With the exception of substance abuse disorders, any past or current Axis I diagnosis as assessed by clinical interview which may include the SCID-NP. With regard to substance abuse, we will allow a history of substance abuse so long as criteria for substance dependence are not met, and the episode(s) of substance abuse occurred over 1 year prior to study enrollment.
• Any prior use of Lysergic acid diethylamide (LSD).
• Use of ecstasy more than 3 times in a lifetime.
• Any history of psychotic symptoms.
• If female, any history of Premenstrual Dysphoric Disorder (PMDD), because PMDD has been shown to correlate with changes in 5-HT1A distribution in brain.
• In women, irregular menses such that the subject will not know the phase of the menstrual cycle at time of scanning.
• Clinically significant laboratory abnormalities.
• Psychotropic medication use (including benzodiazepines and illicit drugs) during the 28 days (42 day for fluoxetine) prior to the PET scan.
• Serious medical problems including but not limited to chronic neurological disease such as multiple sclerosis, autoimmune diseases or any cardiopulmonary disease that would increase risks associated with sedation.
• Positive HIV status.
• Head trauma resulting in a period of unconsciousness lasting longer than 10 minutes.
• History of fetal alcohol syndrome or other neurodevelopmental disorder.
• Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits.
• Positive urine drug screen.
• Inability to lie flat on camera bed for about 2.5 hours.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Alpert JE, Franznick DA, Hollander SB, Fava M. Gepirone extended-release treatment of anxious depression: evidence from a retrospective subgroup analysis in patients with major depressive disorder. J Clin Psychiatry. 2004 Aug;65(8):1069-75.

  PMID: 15323591 BACKGROUND

• Amsterdam JD. Gepirone, a selective serotonin (5HT1A) partial agonist in the treatment of major depression. Prog Neuropsychopharmacol Biol Psychiatry. 1992 May;16(3):271-80. doi: 10.1016/0278-5846(92)90079-t.

  PMID: 1350353 BACKGROUND

• Amsterdam JD, Brunswick DJ, Gibertini M. Sustained efficacy of gepirone-IR in major depressive disorder: a double-blind placebo substitution trial. J Psychiatr Res. 2004 May-Jun;38(3):259-65. doi: 10.1016/j.jpsychires.2003.10.005.

  PMID: 15003431 BACKGROUND

MeSH Terms

Conditions

Depression; Depressive Disorder, Major; Depressive Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Study Officials

• Marta Gozzi, Ph.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: May 27, 2010
• First Posted: May 28, 2010
• Study Start: April 30, 2010
• Study Completion: April 12, 2012
• Last Updated: July 2, 2017

Record last verified: 2012-04-12

Locations

US (1)