Monoamine Contributions to Neurocircuitry in Eating Disorders

NCT02020408 | Completed Phase 4 Results DMC

• 2 other identifiers: 090661R01MH092793
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Eating Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  90 min PET scan

Study Arms (1)

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

EXPERIMENTAL

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.

Drug: [11C]raclopride; Drug: [11C]DASB; Drug: amphetamine

Interventions

[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

Also known as: Raclopride, serial number 009

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

[11C]DASB DRUG

BPND of \[11C\]DASB.

Also known as: DASB, serial number 0011

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

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.

Also known as: dextroamphetamine

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of California San Diego

San Diego, California, 92102, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Interventions

Raclopride; 3-amino-4-(2-dimethylaminomethylphenylsulfanyl)benzonitrile; Amphetamine; Dextroamphetamine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Amphetamines; Phenethylamines; Ethylamines; Amines

Results Point of Contact

• Title: Walter H. Kaye, MD
• Organization: UCSD Department of Psychiatry

wkaye@ucsd.edu

858-534

Study Officials

• Walter Kaye, MD

  UCSD

  PRINCIPAL INVESTIGATOR

• Ursula Bailer, MD

  UCSD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 11, 2013
• First Posted: December 24, 2013
• Study Start: May 1, 2011
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: April 27, 2020
• Results First Posted: April 27, 2020

Record last verified: 2019-12

Locations

US (1)