Trial Outcomes & Findings for PET Imaging Study of Recovered Anorexics (NCT NCT00603018)

NCT ID: NCT00603018

Last Updated: 2016-09-23

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 23 participants
• Primary outcome timeframe: Baseline and 8 weeks
• Results posted on: 2016-09-23

Participant Flow

Participant milestones

Measure	Participants Recovered From Anorexia Before + After Fluoxetine Participants recovered from anorexia Fluoxetine: before 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day.
Overall Study STARTED	23
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PET Imaging Study of Recovered Anorexics

Baseline characteristics by cohort

Measure	1/Recovered Anorevia n=23 Participants Recovered anorexia Fluoxetine: 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day.
Age, Continuous	30.5 years STANDARD_DEVIATION 6.7 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	1/Recovered Anorexia Before 8 Weeks of Treatment n=23 Participants 1/Recovered anorexia before 8 weeks of treatment Baseline	1/Recovered Anorexia After 8 Weeks of Treatment n=23 Participants 1/Recovered anorexia after 8 weeks of treatment Fluoxetine: 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day.
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	5.89 mL/cm^3 Standard Deviation 2.17
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	6.91 mL/cm^3 Standard Deviation 2.62
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	6.29 mL/cm^3 Standard Deviation 3.17
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	9.92 mL/cm^3 Standard Deviation 4.75
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 .16	.58 mL/cm^3 Standard Deviation .36
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	4.12 mL/cm^3 Standard Deviation 1.73
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	6.05 mL/cm^3 Standard Deviation 1.79

Adverse Events

1/Recovered Anorexia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Walter Kaye, MD/Director, Eating Disorders Program Professor, UCSD Department of Psychiatry

UCSD

Phone: 858- 534-8019

Email: wkaye@ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place