Trial Outcomes & Findings for Monoamine Contributions to Neurocircuitry in Eating Disorders (NCT NCT02020408)
NCT ID: NCT02020408
Last Updated: 2020-04-27
Results Overview
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.
COMPLETED
PHASE4
88 participants
90 minute PET scan
2020-04-27
Participant Flow
Participant milestones
| Measure |
[11C]Raclopride, [11C]DASB, Amphetamine
1. healthy control women (CW);
2. women recovered from restricting type anorexia nervosa (REC AN);
3. women recovered from bulimic type anorexia nervosa (REC AN-BN)
4. women recovered from from bulimia nervosa (REC BN)
|
|---|---|
|
Overall Study
STARTED
|
88
|
|
Overall Study
COMPLETED
|
85
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Monoamine Contributions to Neurocircuitry in Eating Disorders
Baseline characteristics by cohort
| Measure |
[11C]Raclopride, [11C]DASB, Amphetamine
n=85 Participants
1. healthy control women (CW);
2. women recovered from restricting type anorexia nervosa (REC AN);
3. women recovered from bulimic type anorexia nervosa (REC AN-BN)
4. women recovered from from bulimia nervosa (REC BN)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
85 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
72 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
85 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 minute PET scanUse 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.
Outcome measures
| Measure |
[11C]DASB Binding Potential Control Women
n=24 Participants
\[11C\] DASB Binding potential (BPND) in control women (healthy controls)
|
[11C]DASB Binding Potential in REC AN
n=18 Participants
\[11C\]DASB binding potential in women recovered from restricting type anorexia nervosa (REC AN)
|
[11C]DASB Binding Potential in REC ANBN
n=16 Participants
\[11C\]DASB binding potential in women recovered from bulimic type anorexia nervosa (REC AN-BN)
|
[11C]DASB Binding Potential in REC BN
n=8 Participants
\[11C\]DASB binding potential in women recovered from bulimia nervosa (REC BN)
|
|---|---|---|---|---|
|
5-HT Transporter Binding as Measured During the PET Scan
[11C]DASB BPND predorsal caudate
|
1.08 binding potential (BPND)
Standard Deviation 0.19
|
0.99 binding potential (BPND)
Standard Deviation 0.32
|
0.99 binding potential (BPND)
Standard Deviation 0.34
|
0.98 binding potential (BPND)
Standard Deviation 0.30
|
|
5-HT Transporter Binding as Measured During the PET Scan
[11C]DASB BPND anteroventral striatum
|
1.68 binding potential (BPND)
Standard Deviation 0.26
|
1.54 binding potential (BPND)
Standard Deviation 0.32
|
1.46 binding potential (BPND)
Standard Deviation 0.47
|
1.60 binding potential (BPND)
Standard Deviation 0.34
|
|
5-HT Transporter Binding as Measured During the PET Scan
[11C]DASB BPND post dorsal caudate
|
0.44 binding potential (BPND)
Standard Deviation 0.15
|
0.35 binding potential (BPND)
Standard Deviation 0.18
|
0.39 binding potential (BPND)
Standard Deviation 0.16
|
0.37 binding potential (BPND)
Standard Deviation 0.19
|
|
5-HT Transporter Binding as Measured During the PET Scan
[11C]DASB BPND posterior putamen
|
1.36 binding potential (BPND)
Standard Deviation 0.25
|
1.27 binding potential (BPND)
Standard Deviation 0.18
|
1.17 binding potential (BPND)
Standard Deviation 0.39
|
1.32 binding potential (BPND)
Standard Deviation 0.29
|
|
5-HT Transporter Binding as Measured During the PET Scan
[11C]DASB BPND anterior putamen
|
1.70 binding potential (BPND)
Standard Deviation 0.26
|
1.59 binding potential (BPND)
Standard Deviation 0.26
|
1.49 binding potential (BPND)
Standard Deviation 0.48
|
1.57 binding potential (BPND)
Standard Deviation 0.28
|
|
5-HT Transporter Binding as Measured During the PET Scan
[11C]DASB BPND midbrain
|
2.21 binding potential (BPND)
Standard Deviation 0.31
|
2.06 binding potential (BPND)
Standard Deviation 0.30
|
1.98 binding potential (BPND)
Standard Deviation 0.60
|
2.17 binding potential (BPND)
Standard Deviation 0.19
|
SECONDARY outcome
Timeframe: 90 min PET scanPopulation: 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.
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. \[VT = distribution volume in tissue; VND = non-displaceable distribution volume\].
Outcome measures
| Measure |
[11C]DASB Binding Potential Control Women
n=14 Participants
\[11C\] DASB Binding potential (BPND) in control women (healthy controls)
|
[11C]DASB Binding Potential in REC AN
n=13 Participants
\[11C\]DASB binding potential in women recovered from restricting type anorexia nervosa (REC AN)
|
[11C]DASB Binding Potential in REC ANBN
n=5 Participants
\[11C\]DASB binding potential in women recovered from bulimic type anorexia nervosa (REC AN-BN)
|
[11C]DASB Binding Potential in REC BN
\[11C\]DASB binding potential in women recovered from bulimia nervosa (REC BN)
|
|---|---|---|---|---|
|
Dopamine D2/D3 Receptor Binding as Measured During the PET Scan After Amphetamine Administration
[11C]raclopride BPND anteroventral striatum
|
2.09 binding potential (BPND)
Standard Deviation 0.22
|
2.01 binding potential (BPND)
Standard Deviation 0.15
|
1.94 binding potential (BPND)
Standard Deviation 0.37
|
—
|
|
Dopamine D2/D3 Receptor Binding as Measured During the PET Scan After Amphetamine Administration
[11C]raclopride BPND post dorsal caudate
|
1.69 binding potential (BPND)
Standard Deviation 0.27
|
1.62 binding potential (BPND)
Standard Deviation 0.19
|
1.69 binding potential (BPND)
Standard Deviation 0.34
|
—
|
|
Dopamine D2/D3 Receptor Binding as Measured During the PET Scan After Amphetamine Administration
[11C]raclopride BPND anterior putamen
|
2.71 binding potential (BPND)
Standard Deviation 0.26
|
2.65 binding potential (BPND)
Standard Deviation 0.22
|
2.60 binding potential (BPND)
Standard Deviation 0.40
|
—
|
|
Dopamine D2/D3 Receptor Binding as Measured During the PET Scan After Amphetamine Administration
[11C]raclopride BPND posterior putamen
|
2.53 binding potential (BPND)
Standard Deviation 0.32
|
2.46 binding potential (BPND)
Standard Deviation 0.26
|
2.47 binding potential (BPND)
Standard Deviation 0.40
|
—
|
|
Dopamine D2/D3 Receptor Binding as Measured During the PET Scan After Amphetamine Administration
[11C]raclopride BPND predorsal caudate
|
2.48 binding potential (BPND)
Standard Deviation 0.30
|
2.40 binding potential (BPND)
Standard Deviation 0.14
|
2.47 binding potential (BPND)
Standard Deviation 0.47
|
—
|
Adverse Events
[11C]Raclopride, [11C]DASB, Amphetamine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
[11C]Raclopride, [11C]DASB, Amphetamine
n=85 participants at risk
1. healthy control women (CW);
2. women recovered from restricting type anorexia nervosa (REC AN);
3. women recovered from bulimic type anorexia nervosa (REC AN-BN)
4. women recovered from from bulimia nervosa (REC BN)
|
|---|---|
|
Cardiac disorders
High blood pressure
|
2.4%
2/85 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place