Monoamine Contributions to Neurocircuitry in Eating Disorders

NCT ID: NCT02020408

Last Updated: 2020-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2017-12-31

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).

Conditions

Eating Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

[11C]raclopride

Intervention Type: 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

[11C]DASB

Intervention Type: DRUG

BPND of \[11C\]DASB.

amphetamine

Intervention Type: DRUG

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

Interventions

[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

Intervention Type: DRUG

[11C]DASB

BPND of \[11C\]DASB.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Raclopride, serial number 009; DASB, serial number 0011; dextroamphetamine

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Walter Kaye

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Walter Kaye, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Ursula Bailer, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

University of California San Diego

San Diego, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01MH092793

Identifier Type: NIH

Identifier Source: secondary_id

View Link

090661

Identifier Type: -

Identifier Source: org_study_id