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.
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
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.
- Conditions
- Eating Disorders
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 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.
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.
- First posted1 May 2008 (estimated)
- Study startJul 2008
- Primary completionJul 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Allegra Broft, MD, Principal investigator, The New York State Psychiatric Institute
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of Dopamine Systems in Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT00670293
- Acronym / sponsor ID
- #5700
- Conditions
- Eating Disorders
- Keywords
- Anorexia Nervosa, PET Imaging, Dopamine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2008
- Primary completion
- Jul 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with anorexia nervosa | – | Radiation: Positron Emission Tomography (PET) using [11C]raclopride, Drug: Methylphenidate, Procedure: Magnetic Resonance Imaging (MRI) scanUnderweight 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 |
| Healthy weight controls | – | Radiation: Positron Emission Tomography (PET) using [11C]raclopride, Drug: Methylphenidate, Procedure: Magnetic Resonance Imaging (MRI) scanParticipants who are healthy controls will undergo Positron Emission Tomography (PET) using [11C]raclopride as well as MRI |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (6 listed)
- 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
- No current or past psychiatric illness
- Between 80% and 120% of ideal body weight
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positron Emission Tomography (PET) using [11C]racloprideParticipants 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. | Radiation | Healthy weight controls, Subjects with anorexia nervosa |
| MethylphenidateThe 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. | Drug | Healthy weight controls, Subjects with anorexia nervosa |
| Magnetic Resonance Imaging (MRI) scanParticipants 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. | Procedure or surgery | Healthy weight controls, Subjects with anorexia nervosa |
Primary outcome
Dopamine receptor binding potential
Time frame: Measured at baseline and after healthy weight restoration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allegra Broft, MD principal investigator
The New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
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.