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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH092793 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will use brain imaging technologies to measure several neurotransmitters (serotonin and dopamine) that contribute to our abilities to respond to reward or inhibit our impulses, and which are known to be altered in the brain of people with anorexia nervosa (AN) and bulimia nervosa (BN). Because palatable food stimulates dopamine secretion, we propose to use a challenge with brain imaging that will stimulate dopamine release which we hypothesize will generate anxiety rather than pleasure in AN, and will help explain why AN restrict eating in order to reduce anxiety. This study will help to understand the unique puzzling symptoms in eating disorders and contribute to finding better methods for identifying effective treatments for these often relapsing and sometimes chronic disorders.
Alterations of serotonin (5-HT) and dopamine (DA) activity may contribute to extremes of appetitive behaviours in anorexia nervosa (AN) and bulimia nervosa (BN), through effects on inhibitory and reward neural pathways. To avoid the confounding effects of malnutrition, and because they have behaviours and neural circuit alterations relevant for this study, we will study 25 recovered (REC) restricting-type AN, 25 REC bulimic-type AN (AN-BN), 25 REC BN, and 25 control women (CW). This 5 year study, of women 18 to 45 years old, will employ positron emission tomography (PET) imaging with radioligands for the 5-HT transporter ([11C]DASB) and DA D2/D3 receptors ([11C]raclopride).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [11C]raclopride, [11C]DASB, amphetamine | Experimental | One time administration of oral amphetamine based on subject's weight (0.5 mg/kg). One PET scan using [11C]DASB. Two PET scans using [11C]raclopride. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [11C]raclopride | Drug | 1.[11C]raclopride -The change (Δ) in BPND (the difference between the [11C]raclopride BPND at baseline and post-AMPH treatment normalized to the baseline BPND |
| Measure | Description | Time Frame |
|---|---|---|
| 5-HT Transporter Binding as Measured During the PET Scan | Use PET and [11C]DASB to explore 5-HTT receptor binding potential midbrain and striatal regions of interest in eating disorder subtypes. The Binding Potential (BP) was calculated as BP Non Displaceable (ND) = (VT/VND) -1. [VT = distribution volume in tissue; VND = non-displaceable distribution volume]. The binding of the 5-HTT on PET presumably reflects 5-HTT density and/or affinity. | 90 minute PET scan |
| Measure | Description | Time Frame |
|---|---|---|
| Dopamine D2/D3 Receptor Binding as Measured During the PET Scan After Amphetamine Administration | Use PET and [11C]raclopride to explore Dopamine D2/D3 receptor binding potential (BPND) in striatal regions of interest in eating disorder subtypes after amphetamine administration. The Binding Potential (BP) was calculated as BP Non Displaceable (ND) = (VT/VND) -1. [VT = distribution volume in tissue; VND = non-displaceable distribution volume]. |
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Inclusion
Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| Walter Kaye, MD | UCSD | Principal Investigator |
| Ursula Bailer, MD | UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | San Diego | California | 92102 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | [11C]Raclopride, [11C]DASB, Amphetamine |
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| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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According to the study protocol and inclusion criteria all participants needed to be female, between age 18 and 65 and were enrolled in the US.
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| ID | Title | Description |
|---|---|---|
| BG000 | [11C]Raclopride, [11C]DASB, Amphetamine |
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| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 5-HT Transporter Binding as Measured During the PET Scan | Use PET and [11C]DASB to explore 5-HTT receptor binding potential midbrain and striatal regions of interest in eating disorder subtypes. The Binding Potential (BP) was calculated as BP Non Displaceable (ND) = (VT/VND) -1. [VT = distribution volume in tissue; VND = non-displaceable distribution volume]. The binding of the 5-HTT on PET presumably reflects 5-HTT density and/or affinity. | Posted | Mean | Standard Deviation | binding potential (BPND) | 90 minute PET scan |
|
5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | [11C]Raclopride, [11C]DASB, Amphetamine |
|
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| High blood pressure | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Walter H. Kaye, MD | UCSD Department of Psychiatry | 858-534 | 8019 | wkaye@ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 9, 2015 | Jun 24, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D020891 | Raclopride |
| C412822 | 3-amino-4-(2-dimethylaminomethylphenylsulfanyl)benzonitrile |
| D000661 | Amphetamine |
| D003913 | Dextroamphetamine |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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|
| [11C]DASB | Drug | BPND of [11C]DASB. |
|
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| amphetamine | Drug | The change (Δ) in BPND (the difference between the [11C]raclopride BPND at baseline and post-AMPH treatment normalized to the baseline BPND. |
|
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| 90 min PET scan |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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[11C]DASB binding potential in women recovered from restricting type anorexia nervosa (REC AN)
| OG002 | [11C]DASB Binding Potential in REC ANBN | [11C]DASB binding potential in women recovered from bulimic type anorexia nervosa (REC AN-BN) |
| OG003 | [11C]DASB Binding Potential in REC BN | [11C]DASB binding potential in women recovered from bulimia nervosa (REC BN) |
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|
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| Secondary | Dopamine D2/D3 Receptor Binding as Measured During the PET Scan After Amphetamine Administration | Use PET and [11C]raclopride to explore Dopamine D2/D3 receptor binding potential (BPND) in striatal regions of interest in eating disorder subtypes after amphetamine administration. The Binding Potential (BP) was calculated as BP Non Displaceable (ND) = (VT/VND) -1. [VT = distribution volume in tissue; VND = non-displaceable distribution volume]. | Due to technical problems and temporary closure of the PET Facility during the study and consequent lack of time and funding for additional scanning, we were unable to recruit a sufficient number of women recovered from bulimia nervosa (BN) for the AMPHETAMINE CHALLENGE STUDY and therefore no data for this outcome measure were collected in REC BN. | Posted | Mean | Standard Deviation | binding potential (BPND) | 90 min PET scan |
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| 0 |
| 85 |
| 0 |
| 85 |
| 2 |
| 85 |
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| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
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| [11C]raclopride BPND anterior putamen |
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| [11C]raclopride BPND posterior putamen |
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| [11C]raclopride BPND predorsal caudate |
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