Anorexia NervosaNCT00603018
PET Imaging Study of Recovered Anorexics
A study testing Fluoxetine in people with Anorexia Nervosa, run by University of Pittsburgh at 1 site in United States.
Trial summary
Several studies in the past suggest that individuals who have or had anorexia nervosa may have alterations in brain serotonin. Serotonin seems to play an important role in regulating anxiety, mood, and other symptoms found in anorexia nervosa. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Fluoxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Dec 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recovered from Anorexia Nervosa
- Not taking medication for emotional problems
- Regular menstrual cycle
Who cannot join
- Women who are pregnant or nursing
- Psychoactive medications in the past 30 days
- Neurological disorders.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: PET Imaging of Dopaminergic Transmission and Serotonin Markers in Anorexia Nervosa
Several studies in the past suggest that individuals who have or had anorexia nervosa may have alterations in brain serotonin. Serotonin seems to play an important role in regulating anxiety, mood, and other symptoms found in anorexia nervosa. We will be using a technology called Positron Emission Tomography (PET), which is a method used to take pictures of the body, in this case, the brain. Study participants will undergo two baseline PET scans on the first day of the study. The women who have recovered from anorexia will then be given a medication called fluoxetine (also know as Prozac) to take for 8 weeks. At the end of the 8th week, they will return for a third PET scan. By comparing the brain scans, before and after fluoxetine treatment, we can understand more about how treatment with fluoxetine affects the serotonin receptors in the brain. We will be comparing brain serotonin system in women who have recovered from anorexia before and after medication in order to gain a better understanding of changes in the serotonin system associated with eating disorders. This study may help shed light on how to make fluoxetine a more effective treatment for anorexia nervosa.
- Conditions
- Anorexia Nervosa
- Being tested
- Fluoxetine
- Keywords
- eating disorders, anorexia nervosa, anorexia, PET, brain imaging, serotonin, fMRI, Prozac, fluoxetine
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders, Anorexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
Also called Prozac
8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day.
| Study group | Role | What they receive |
|---|---|---|
| Annorexia nervosa | Experimental | Participants recovered from anorexia nervosa before and after administration of fluoxetine Receives: Drug: Fluoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serotonin Receptor 1A Binding Potential In Regions of Interest (ROI) Accounting for Binding Potential in a Region Without Serotonin 1A Receptors
We used PET and [11C]WAY to assess 5-HT1A binding potential (BP) = [11C]WAY 100635 BP = Distribution Volume (DV)ROI-DVcerebellum in striatal regions; subcortical regions including insula, medial temporal lobe, amygdala, hippocampus, midbrain, parahippocampal gyrus; and the neocortical regions (i.e., anterior cingulate cortex). Analysis of the PET data was performed using the Logan graphical method (Logan et al. 2001) with the cerebellum as a reference region for non-displaceable uptake. 23 REC AN were studied. The Binding Potential (BP) was calculated as followed: BPP = fP Bavail/KD = VT-VND;(Abbrev.: BPP = In vivo binding potential; fP = free fraction in plasma; Bavail = Density of receptors available to bind radioligand in vivo; KD = Dissociation Constant; V = Volumes of Distribution expressed relative to total plasma ligand concentration; T = Total radioligand in tissue; ND = Nondisplaceable tissue uptake; see Innis et al. 2007); Units: mL cm -3
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startJun 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Walter Kaye, University of Pittsburgh
- Investigators
- Walter Kaye, M.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603018
- Sponsor's protocol ID
- PRO06110005
- Status last verified
- Aug 2016
- First submitted
- 16 Oct 2007
- Last updated
- 23 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Imaging of Dopaminergic Transmission and Serotonin Markers in Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT00603018
- Acronym / sponsor ID
- PRO06110005
- Conditions
- Anorexia Nervosa
- Keywords
- eating disorders, anorexia nervosa, anorexia, PET, brain imaging, serotonin, fMRI, Prozac
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Posted 23 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Several studies in the past suggest that individuals who have or had anorexia nervosa may have alterations in brain serotonin. Serotonin seems to play an important role in regulating anxiety, mood, and other symptoms found in anorexia nervosa. We will be using a technology called Positron Emission Tomography (PET), which is a method used to take pictures of the body, in this case, the brain. Study participants will undergo two baseline PET scans on the first day of the study. The women who have recovered from anorexia will then be given a medication called fluoxetine (also know as Prozac) to take for 8 weeks. At the end of the 8th week, they will return for a third PET scan. By comparing the brain scans, before and after fluoxetine treatment, we can understand more about how treatment with fluoxetine affects the serotonin receptors in the brain. We will be comparing brain serotonin system in women who have recovered from anorexia before and after medication in order to gain a better understanding of changes in the serotonin system associated with eating disorders. This study may help shed light on how to make fluoxetine a more effective treatment for anorexia nervosa.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Annorexia nervosa | Experimental | Drug: FluoxetineParticipants recovered from anorexia nervosa before and after administration of fluoxetine |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Recovered from Anorexia Nervosa
- Not taking medication for emotional problems
- Regular menstrual cycle
Key exclusion criteria (3 listed)
- Women who are pregnant or nursing
- Psychoactive medications in the past 30 days
- Neurological disorders.
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 |
|---|---|---|
| FluoxetineAlso: Prozac8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day. | Drug | Annorexia nervosa |
Primary outcome
Serotonin Receptor 1A Binding Potential In Regions of Interest (ROI) Accounting for Binding Potential in a Region Without Serotonin 1A Receptors
Time frame: Baseline and 8 weeks
We used PET and [11C]WAY to assess 5-HT1A binding potential (BP) = [11C]WAY 100635 BP = Distribution Volume (DV)ROI-DVcerebellum in striatal regions; subcortical regions including insula, medial temporal lobe, amygdala, hippocampus, midbrain, parahippocampal gyrus; and the neocortical regions (i.e., anterior cingulate cortex). Analysis of the PET data was performed using the Logan graphical method (Logan et al. 2001) with the cerebellum as a reference region for non-displaceable uptake. 23 REC AN were studied. The Binding Potential (BP) was calculated as followed: BPP = fP Bavail/KD = VT-VND;(Abbrev.: BPP = In vivo binding potential; fP = free fraction in plasma; Bavail = Density of receptors available to bind radioligand in vivo; KD = Dissociation Constant; V = Volumes of Distribution expressed relative to total plasma ligand concentration; T = Total radioligand in tissue; ND = Nondisplaceable tissue uptake; see Innis et al. 2007); Units: mL cm -3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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.
Walter Kaye, M.D. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoxetine in people with Anorexia Nervosa, run by University of Pittsburgh 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 3 inclusion and 3 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 23 Sep 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?
Yes. Results are posted in the registry (first posted 23 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Serotonin Receptor 1A Binding Potential In Regions of Interest (ROI) Accounting for Binding Potential in a Region Without Serotonin 1A Receptors (time frame: Baseline and 8 weeks). 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 23 Sep 2016.