Anorexia Nervosa
Conditions
Keywords
eating disorders, anorexia nervosa, anorexia, PET, brain imaging, serotonin, fMRI, Prozac, fluoxetine
Brief 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. 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.
Interventions
DRUGFluoxetine
8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day.
Sponsors
National Institute of Mental Health (NIMH)
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Recovered from Anorexia Nervosa * Not taking medication for emotional problems * Regular menstrual cycle
Exclusion criteria
* Women who are pregnant or nursing * Psychoactive medications in the past 30 days * Neurological disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serotonin Receptor 1A Binding Potential In Regions of Interest (ROI) Accounting for Binding Potential in a Region Without Serotonin 1A Receptors | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1/Recovered Anorevia Recovered anorexia
Fluoxetine: 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day. | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | 1/Recovered Anorevia |
|---|---|
| Age, Continuous | 30.5 years STANDARD_DEVIATION 6.7 |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
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
Time frame: Baseline and 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1/Recovered Anorexia Before 8 Weeks of Treatment | Serotonin Receptor 1A Binding Potential In Regions of Interest (ROI) Accounting for Binding Potential in a Region Without Serotonin 1A Receptors | amygdala | 5.91 mL/cm^3 | Standard Deviation 2.85 |
| 1/Recovered Anorexia Before 8 Weeks of Treatment | Serotonin Receptor 1A Binding Potential In Regions of Interest (ROI) Accounting for Binding Potential in a Region Without Serotonin 1A Receptors | midbrain | 0.37 mL/cm^3 | Standard Deviation 0.16 |
| 1/Recovered Anorexia Before 8 Weeks of Treatment | Serotonin Receptor 1A Binding Potential In Regions of Interest (ROI) Accounting for Binding Potential in a Region Without Serotonin 1A Receptors | medial temporal lobe | 6.66 mL/cm^3 | Standard Deviation 2.14 |
| 1/Recovered Anorexia Before 8 Weeks of Treatment | Serotonin Receptor 1A Binding Potential In Regions of Interest (ROI) Accounting for Binding Potential in a Region Without Serotonin 1A Receptors | anterior cingulate cortex | 3.83 mL/cm^3 | Standard Deviation 1.14 |
| 1/Recovered Anorexia Before 8 Weeks of Treatment | Serotonin Receptor 1A Binding Potential In Regions of Interest (ROI) Accounting for Binding Potential in a Region Without Serotonin 1A Receptors | hippocampus | 9.08 mL/cm^3 | Standard Deviation 3.98 |
| 1/Recovered Anorexia Before 8 Weeks of Treatment | Serotonin Receptor 1A Binding Potential In Regions of Interest (ROI) Accounting for Binding Potential in a Region Without Serotonin 1A Receptors | parahippocampal gyrus | 6.08 mL/cm^3 | Standard Deviation 1.57 |
| 1/Recovered Anorexia Before 8 Weeks of Treatment | Serotonin Receptor 1A Binding Potential In Regions of Interest (ROI) Accounting for Binding Potential in a Region Without Serotonin 1A Receptors | insula | 5.97 mL/cm^3 | Standard Deviation 1.43 |
| 1/Recovered Anorexia After 8 Weeks of Treatment | Serotonin Receptor 1A Binding Potential In Regions of Interest (ROI) Accounting for Binding Potential in a Region Without Serotonin 1A Receptors | parahippocampal gyrus | 6.05 mL/cm^3 | Standard Deviation 1.79 |
| 1/Recovered Anorexia After 8 Weeks of Treatment | Serotonin Receptor 1A Binding Potential In Regions of Interest (ROI) Accounting for Binding Potential in a Region Without Serotonin 1A Receptors | insula | 5.89 mL/cm^3 | Standard Deviation 2.17 |
| 1/Recovered Anorexia After 8 Weeks of Treatment | Serotonin Receptor 1A Binding Potential In Regions of Interest (ROI) Accounting for Binding Potential in a Region Without Serotonin 1A Receptors | medial temporal lobe | 6.91 mL/cm^3 | Standard Deviation 2.62 |
| 1/Recovered Anorexia After 8 Weeks of Treatment | Serotonin Receptor 1A Binding Potential In Regions of Interest (ROI) Accounting for Binding Potential in a Region Without Serotonin 1A Receptors | amygdala | 6.29 mL/cm^3 | Standard Deviation 3.17 |
| 1/Recovered Anorexia After 8 Weeks of Treatment | Serotonin Receptor 1A Binding Potential In Regions of Interest (ROI) Accounting for Binding Potential in a Region Without Serotonin 1A Receptors | hippocampus | 9.92 mL/cm^3 | Standard Deviation 4.75 |
| 1/Recovered Anorexia After 8 Weeks of Treatment | Serotonin Receptor 1A Binding Potential In Regions of Interest (ROI) Accounting for Binding Potential in a Region Without Serotonin 1A Receptors | midbrain | .58 mL/cm^3 | Standard Deviation 0.36 |
| 1/Recovered Anorexia After 8 Weeks of Treatment | Serotonin Receptor 1A Binding Potential In Regions of Interest (ROI) Accounting for Binding Potential in a Region Without Serotonin 1A Receptors | anterior cingulate cortex | 4.12 mL/cm^3 | Standard Deviation 1.73 |