Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-30 @ 11:55 AM
Study NCT ID:
NCT00670293
Status:
COMPLETED
Last Update Posted:
2016-04-07
First Post:
2008-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Dopamine Levels Before and After Weight Restoration in People With Anorexia Nervosa
Sponsor:
New York State Psychiatric Institute
Organization:
Study Overview
Official Title:
Imaging of Dopamine Systems in Anorexia Nervosa
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01MH079397 | NIH | None | https://reporter.nih.gov/quic… | View |