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Eating DisordersNCT00670293

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

An observational study of Eating Disorders, run by New York State Psychiatric Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Eating Disorders
What is being tested?
Positron Emission Tomography (PET) using [11C]raclopride, Methylphenidate and Magnetic Resonance Imaging (MRI) scan
Type of treatment
Surgery or procedure
How many people
50 participants
Where
1 siteUnited States
Study dates
Jul 2008to Dec 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • New York State Psychiatric Institute

    New York, New York, 10032

Other trials in United States

About this study

Official title: Imaging of Dopamine Systems in Anorexia Nervosa

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

Read the detailed description

Anorexia nervosa (AN) is a disordered eating disease characterized by a persistent pursuit of thinness, intense fear of weight gain, distorted body image, and obsessive eating habits. People with AN are at high risk for certain health problems, such as depression, osteoporosis, substance abuse, and cardiovascular and neurological complications. Current treatments for AN include different forms of psychotherapy and medications, but the success of these treatments is highly variable among people with AN. A better pathophysiologic understanding of AN is needed in order to develop novel therapeutic strategies for preventing and treating the disorder. Current research is targeting dopamine (DA), a neurotransmitter that is released in response to pleasurable stimuli, such as food and drugs. Animal studies have found that chronic food restriction may alter functioning of the DA system by reducing DA response to food and drug stimuli. A better understanding of the effects of disordered eating on the DA systems of people with AN may provide insight into the development of new and improved treatments for people with AN. This study will use positron emission tomography (PET) imaging to investigate changes in DA systems in people with AN before and after both weight restoration and administration of methylphenidate, a psychostimulant medication. The study will also use PET imaging to compare DA systems of people with AN with DA systems of people who are healthy.

This study will involve both healthy participants and participants with AN. Study participation for healthy participants will include two PET scans and one magnetic resonance imaging (MRI) scan, which, if the participants prefer, can all be completed in one study visit. Study participation for participants with AN will include three PET and two MRI scans. The first PET and MRI scans will be performed upon entry into the hospital as an inpatient. The remaining scans will be conducted 2 to 4 weeks after participants have accomplished weight restoration.

Including preparation, each MRI study will last about 45 minutes and each PET study will last about 3 hours. For each MRI study, participants will be asked to lie on their backs for 15 minutes in the MRI scanner. For each PET study, participants will first be injected with a dose of [11C]raclopride, a radioactive drug used in brain imaging, and will then lie on their backs for 30 minutes in the PET scanner.

One hour before the second PET scan for healthy participants and the third PET scan for participants with AN, participants will receive an oral dose of methylphenidate. During these scans, participants will also undergo blood pressure monitoring and an electrocardiogram (EKG). Once participants no longer feel the effects of the methylphenidate and their vital signs have returned to normal, they will be discharged from the medical center and study participation will be complete.

Being tested
Positron Emission Tomography (PET) using [11C]raclopride, Methylphenidate, Magnetic Resonance Imaging (MRI) scan
Keywords
Anorexia Nervosa, PET Imaging, Dopamine
Medical subject headings
Feeding and Eating Disorders, Anorexia Nervosa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Positron Emission Tomography (PET) using [11C]racloprideRadiation

    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.

  • MethylphenidateDrug

    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.

  • Magnetic Resonance Imaging (MRI) scanProcedure or surgery

    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.

Study groups in NCT00670293
Study groupRoleWhat they receive
Subjects with anorexia nervosaUnderweight 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
Receives: Radiation: Positron Emission Tomography (PET) using [11C]raclopride; Drug: Methylphenidate; Procedure: Magnetic Resonance Imaging (MRI) scan
Healthy weight controlsParticipants who are healthy controls will undergo Positron Emission Tomography (PET) using [11C]raclopride as well as MRI
Receives: Radiation: Positron Emission Tomography (PET) using [11C]raclopride; Drug: Methylphenidate; Procedure: Magnetic Resonance Imaging (MRI) scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dopamine receptor binding potential

    Measured: Measured at baseline and after healthy weight restoration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionJul 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00670293
Sponsor's protocol ID
#5700
Other IDs
R01MH079397
Status last verified
Aug 2015
First submitted
29 Apr 2008
Last updated
7 Apr 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Eating Disorders, run by New York State Psychiatric Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dopamine receptor binding potential (time frame: Measured at baseline and after healthy weight restoration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2016.

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