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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00670293 |
This study will use positron emission tomography imaging to investigate changes in dopamine systems in people with anorexia nervosa before and after weight restoration.
Condition | Intervention |
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Eating Disorders |
Radiation: Positron Emission Tomography (PET) using [11C]raclopride Drug: Methylphenidate Procedure: Magnetic Resonance Imaging (MRI) scan |
Study Type: | Observational |
Study Design: | Case Control, Cross-Sectional |
Official Title: | Imaging of Dopamine Systems in Anorexia Nervosa |
Estimated Enrollment: | 51 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | February 2013 |
Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Underweight participants with anorexia nervosa who will restore normal weight levels after inpatient treatment
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Radiation: Positron Emission Tomography (PET) using [11C]raclopride
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.
Drug: Methylphenidate
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.
Procedure: Magnetic Resonance Imaging (MRI) scan
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.
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2
Participants who are healthy controls
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Radiation: Positron Emission Tomography (PET) using [11C]raclopride
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.
Drug: Methylphenidate
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.
Procedure: Magnetic Resonance Imaging (MRI) scan
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.
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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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Participants with AN:
Healthy control participants:
Exclusion Criteria:
All participants:
Contact: Rebecca Shingleton | 212-543-5151 | rshingl@pi.cpmc.columbia.edu |
United States, New York | |
New York State Psychiatric Institute | Recruiting |
New York, New York, United States, 10032 | |
Contact: Allegra Broft, MD 212-543-6147 |
Principal Investigator: | Allegra Broft, MD | The New York State Psychiatric Institute |
Responsible Party: | The New York State Psychiatric Institute ( B.T. Walsh, MD ) |
Study ID Numbers: | R01 MH079397, DATR A2-AID |
Study First Received: | April 29, 2008 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00670293 |
Health Authority: | United States: Federal Government |
Anorexia Nervosa PET Imaging Dopamine |
Body Weight Signs and Symptoms Dopamine Signs and Symptoms, Digestive Mental Disorders |
Raclopride Anorexia Methylphenidate Anorexia Nervosa Eating Disorders |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cardiotonic Agents Sympathomimetics Physiological Effects of Drugs Central Nervous System Stimulants |
Cardiovascular Agents Protective Agents Pharmacologic Actions Autonomic Agents Therapeutic Uses Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |