Monoamine Contributions to Neurocircuitry in Eating Disorders

Eating Disorder Clinical Trial

Official title:

Monoamine Contributions to Neurocircuitry in Eating Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02020408
• Other study ID #: 090661
• Secondary ID: R01MH092793
• Status: Completed
• Phase: Phase 4
• Start date: May 2011
• Est. completion date: December 31, 2017

Study information

• Verified date: December 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eating Disorder
• Feeding and Eating Disorders

Intervention

Drug:
• [11C]raclopride
1.[11C]raclopride -The change (?) in BPND (the difference between the [11C]raclopride BPND at baseline and post-AMPH treatment normalized to the baseline BPND
• [11C]DASB
BPND of [11C]DASB.
• amphetamine
The change (?) in BPND (the difference between the [11C]raclopride BPND at baseline and post-AMPH treatment normalized to the baseline BPND.

Locations

Country	Name	City	State
United States	University of California San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	90 minute PET scan
Secondary	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].	90 min PET scan