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OpenTrials
Completed

NCT Number: NCT02020408

Monoamine Contributions to Neurocircuitry in Eating Disorders

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.

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Key information

Conditions

Eating Disorder Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of California San Diego

San Diego, California, 92102, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[11C]raclopride

Drug

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

Other names: Raclopride, serial number 009

[11C]DASB

Drug

BPND of [11C]DASB.

Other names: DASB, serial number 0011

Amphetamine

Drug

The change (Δ) in BPND (the difference between the [11C]raclopride BPND at baseline and post-AMPH treatment normalized to the baseline BPND.

Other names: dextroamphetamine

Primary outcomes

  1. 5-HT Transporter Binding as Measured During the PET Scan

    Time frame: 90 minute 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 outcomes

  1. Dopamine D2/D3 Receptor Binding as Measured During the PET Scan After Amphetamine Administration

    Time frame: 90 min PET scan

    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].

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Dec 24, 2013
Registry last updated
Apr 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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