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Monoamine Contributions to Neurocircuitry in Eating Disorders

Primary Purpose

Eating Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
[11C]raclopride
[11C]DASB
amphetamine
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Eating Disorder

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion

  • history of Diagnostic and Statistical Manual (DSM-IV) diagnosis of anorexia or bulimia.
  • AN women have history of average body weight (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

  • 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.

Sites / Locations

  • University of California San Diego

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[11C]raclopride, [11C]DASB, amphetamine

Arm Description

One time administration of oral amphetamine based on subject's weight (0.5 mg/kg). One PET scan using [11C]DASB. Two PET scans using [11C]raclopride.

Outcomes

Primary Outcome Measures

5-HT Transporter Binding as Measured During the PET Scan
Use PET and [11C]DASB to explore 5-HTT receptor binding potential midbrain and striatal regions of interest in eating disorder subtypes. The Binding Potential (BP) was calculated as BP Non Displaceable (ND) = (VT/VND) -1. [VT = distribution volume in tissue; VND = non-displaceable distribution volume]. The binding of the 5-HTT on PET presumably reflects 5-HTT density and/or affinity.

Secondary Outcome Measures

Dopamine D2/D3 Receptor Binding as Measured During the PET Scan After Amphetamine Administration
Use PET and [11C]raclopride to explore Dopamine D2/D3 receptor binding potential (BPND) in striatal regions of interest in eating disorder subtypes after amphetamine administration. The Binding Potential (BP) was calculated as BP Non Displaceable (ND) = (VT/VND) -1. [VT = distribution volume in tissue; VND = non-displaceable distribution volume].

Full Information

First Posted
December 11, 2013
Last Updated
April 7, 2020
Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02020408
Brief Title
Monoamine Contributions to Neurocircuitry in Eating Disorders
Official Title
Monoamine Contributions to Neurocircuitry in Eating Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
[11C]raclopride, [11C]DASB, amphetamine
Arm Type
Experimental
Arm Description
One time administration of oral amphetamine based on subject's weight (0.5 mg/kg). One PET scan using [11C]DASB. Two PET scans using [11C]raclopride.
Intervention Type
Drug
Intervention Name(s)
[11C]raclopride
Other Intervention Name(s)
Raclopride, serial number 009
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
[11C]DASB
Other Intervention Name(s)
DASB, serial number 0011
Intervention Description
BPND of [11C]DASB.
Intervention Type
Drug
Intervention Name(s)
amphetamine
Other Intervention Name(s)
dextroamphetamine
Intervention Description
The change (Δ) in BPND (the difference between the [11C]raclopride BPND at baseline and post-AMPH treatment normalized to the baseline BPND.
Primary Outcome Measure Information:
Title
5-HT Transporter Binding as Measured During the PET Scan
Description
Use PET and [11C]DASB to explore 5-HTT receptor binding potential midbrain and striatal regions of interest in eating disorder subtypes. The Binding Potential (BP) was calculated as BP Non Displaceable (ND) = (VT/VND) -1. [VT = distribution volume in tissue; VND = non-displaceable distribution volume]. The binding of the 5-HTT on PET presumably reflects 5-HTT density and/or affinity.
Time Frame
90 minute PET scan
Secondary Outcome Measure Information:
Title
Dopamine D2/D3 Receptor Binding as Measured During the PET Scan After Amphetamine Administration
Description
Use PET and [11C]raclopride to explore Dopamine D2/D3 receptor binding potential (BPND) in striatal regions of interest in eating disorder subtypes after amphetamine administration. The Binding Potential (BP) was calculated as BP Non Displaceable (ND) = (VT/VND) -1. [VT = distribution volume in tissue; VND = non-displaceable distribution volume].
Time Frame
90 min PET scan

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion history of Diagnostic and Statistical Manual (DSM-IV) diagnosis of anorexia or bulimia. AN women have history of average body weight (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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Kaye, MD
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ursula Bailer, MD
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States

12. IPD Sharing Statement

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Monoamine Contributions to Neurocircuitry in Eating Disorders

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