Changes in Dopamine Levels Before and After Weight Restoration in People With Anorexia Nervosa

NCT00670293 | Completed

• 2 other identifiers: #5700R01MH079397
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study will use positron emission tomography imaging to investigate changes in dopamine systems in people with anorexia nervosa before and after weight restoration.

Conditions

Eating Disorders

Keywords

Anorexia Nervosa; PET Imaging; Dopamine

Outcome Measures

Primary Outcomes (1)

• Dopamine receptor binding potential

  Measured at baseline and after healthy weight restoration

Study Arms (2)

Subjects with anorexia nervosa

Underweight participants with anorexia nervosa who will restore normal weight levels after inpatient treatment will undergo Positron Emission Tomography (PET) using \[11C\]raclopride as well as MRI

Radiation: Positron Emission Tomography (PET) using [11C]raclopride; Drug: Methylphenidate; Procedure: Magnetic Resonance Imaging (MRI) scan

Healthy weight controls

Participants who are healthy controls will undergo Positron Emission Tomography (PET) using \[11C\]raclopride as well as MRI

Radiation: Positron Emission Tomography (PET) using [11C]raclopride; Drug: Methylphenidate; Procedure: Magnetic Resonance Imaging (MRI) scan

Interventions

Positron Emission Tomography (PET) using [11C]raclopride RADIATION

Participants with AN will undergo three PET scans at two separate time points. The first scan will occur when participants are underweight (but not less than 75% ideal body weight), and the second and third scans will occur 2 to 4 weeks after participants have accomplished weight restoration. Healthy participants will have two PET scans at a single timepoint.

Healthy weight controls; Subjects with anorexia nervosa

Methylphenidate DRUG

The second PET scan for healthy participants and third PET scan for participants with AN will be performed after administration of 60 mg of methylphenidate, a psychostimulant that allows for accumulation of dopamine (DA) extraneuronally.

Healthy weight controls; Subjects with anorexia nervosa

Magnetic Resonance Imaging (MRI) scan PROCEDURE

Participants with AN will undergo two MRI scans, and healthy participants will undergo one MRI scan. The scans will be conducted in conjunction with the PET scans.

Healthy weight controls; Subjects with anorexia nervosa

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include people with anorexia nervosa seeking inpatient treatment or already receiving inpatient treatment and people who will act as healthy control participants.

You may qualify if:

• Participants with AN:
• Meets DSM-IV criteria for AN or ED-NOS (meets criteria for AN except amenorrhea)
• Sufficiently medically and psychiatrically stable to leave inpatient unit, as assessed by clinical team
• Healthy control participants:
• No current or past psychiatric illness
• Between 80% and 120% of ideal body weight

You may not qualify if:

• All participants:
• Current use of psychotropic medication such as antipsychotics or antidepressants
• Pregnant or breastfeeding
• History of a substance use disorder
• Significant medical illness
• High blood pressure (resting systolic blood pressure greater than 140 mmHg and diastolic blood pressure greater than 90 mmHg)
• Current or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder as defined by DSM-IV-TR
• Metal implants or paramagnetic objects contained within the body that may interfere with the MRI scan, as determined in consultation with a neuroradiologist and according to specified reference book guidelines
• Exposed to radiation in the workplace or has had a nuclear medicine procedure during the 1 year before study entry
• Previous adverse reaction to psychostimulants

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders; Anorexia Nervosa

Interventions

Magnetic Resonance Spectroscopy; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole; Methylphenidate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Allegra Broft, MD

  The New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2008
• First Posted: May 1, 2008
• Study Start: July 1, 2008
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 7, 2016

Record last verified: 2015-08

Locations

US (1)