Monoamine Contributions to Neurocircuitry in Eating Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of California, San Diego
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Walter Kaye, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT02020408
First received: December 11, 2013
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

This study will use brain imaging technologies to measure several neurotransmitters (serotonin and dopamine) that contribute to our abilities to respond to reward or inhibit our impulses, and which are known to be altered in the brain of people with anorexia nervosa (AN) and bulimia nervosa (BN). Because palatable food stimulates dopamine secretion, we propose to use a challenge with brain imaging that will stimulate dopamine release which we hypothesize will generate anxiety rather than pleasure in AN, and will help explain why AN restrict eating in order to reduce anxiety. This study will help to understand the unique puzzling symptoms in eating disorders and contribute to finding better methods for identifying effective treatments for these often relapsing and sometimes chronic disorders.


Condition Intervention Phase
Eating Disorder
Drug: [11C]raclopride
Drug: [11C]DASB
Drug: amphetamine
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Monoamine Contributions to Neurocircuitry in Eating Disorders

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 1. 5-HT transporter binding and Dopamine (DA) D2/D3 binding as measured during the PET scan [ Time Frame: 90 minute PET scan ] [ Designated as safety issue: No ]
    Use PET and [11C]DASB and [11C]raclopride to explore 5-HTT and DA D2/D3 receptor binding potential in cortical, subcortical and striatal ROIs.


Secondary Outcome Measures:
  • Change in [11C]raclopride binding potential from baseline to post-amphetamine administration as measured during the two 90 min PET scans. [ Time Frame: Two 90 min PET scans ] [ Designated as safety issue: No ]
    The change (Δ) in BPND (the difference between the [11C]raclopride BPND at baseline and post-AMPH treatment normalized to the baseline BPND).


Estimated Enrollment: 120
Study Start Date: May 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: [11C]raclopride, [11C]DASB, amphetamine Drug: [11C]raclopride
1.[11C]raclopride -The change (Δ) in BPND (the difference between the [11C]raclopride BPND at baseline and post-AMPH treatment normalized to the baseline BPND
Drug: [11C]DASB
BPND of [11C]DASB.
Drug: amphetamine
The change (Δ) in BPND (the difference between the [11C]raclopride BPND at baseline and post-AMPH treatment normalized to the baseline BPND.

Detailed Description:

Alterations of serotonin (5-HT) and dopamine (DA) activity may contribute to extremes of appetitive behaviours in anorexia nervosa (AN) and bulimia nervosa (BN), through effects on inhibitory and reward neural pathways. To avoid the confounding effects of malnutrition, and because they have behaviours and neural circuit alterations relevant for this study, we will study 25 recovered (REC) restricting-type AN, 25 REC bulimic-type AN (AN-BN), 25 REC BN, and 25 control women (CW). This 5 year study, of women 18 to 45 years old, will employ positron emission tomography (PET) imaging with radioligands for the 5-HT transporter ([11C]DASB) and DA D2/D3 receptors ([11C]raclopride).

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for women who have recovered from anorexia (AN) and/or bulimia (BN):

  • history of DSM-IV diagnosis of anorexia or bulimia.
  • AN women have history of ABW below 85% for height.
  • AN-BN subjects have history of ABW below 85% ABW.
  • AN-BN subjects have history of binging/purging behaviors during a period of low weight.
  • Subjects must be right-handed.
  • Subjects have been recovered for 12 months or more.

Exclusion Criteria for women who have recovered from anorexia (AN) and/or bulimia (BN):

  • Diagnosis of alcohol or drug abuse or dependence in the 3 months.
  • Alcohol or substance use within 30 days.
  • Current diagnosis of an Axis I disorder.
  • Organic brain syndromes, dementia, psychotic disorders, or mental retardation.
  • Neurological or medical disorders such as seizure disorder, renal disease, diabetes, thyroid disease, EKG indicative of electrolyte imbalance
  • BN subjects whose purging methods were the use of laxatives, diuretics
  • Use of psychoactive medication in the 3 months.
  • Pregnancy or lactation.
  • Tobacco use in the 3 months.

Inclusion Criteria for control women:

- ABW between 90% and 120% since menarche.

Exclusion Criteria for control women:

  • Current or past psychiatric, medical or neurological illness.
  • Pregnancy and lactation.
  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: NCT02020408

Contacts
Contact: Ursula Bailer, MD 8585348063 ubailer@ucsd.edu
Contact: Daria Orlowska, MS 8585348031 dorlowsk@ucsd.edu

Locations
United States, California
University of California San Diego Recruiting
San Diego, California, United States, 92102
Contact: Daria Orlowska, MS    858-534-8031    dorlowsk@ucsd.edu   
Contact: Ursula Bailer, MD    8585348063    ubailer@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Walter Kaye, MD UCSD
  More Information

No publications provided

Responsible Party: Walter Kaye, MD, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02020408     History of Changes
Other Study ID Numbers: 090661
Study First Received: December 11, 2013
Last Updated: February 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Eating Disorders
Mental Disorders
Amphetamine
Raclopride
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists

ClinicalTrials.gov processed this record on July 20, 2014