NCT01401595

Brain Imaging and Treatment Studies of the Night Eating Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the effectiveness of the anti-depressant Lexapro in the treatment of the Night Eating Syndrome.

Detailed description

This proposal explores the implications of our two recent major discoveries: the striking efficacy of the Selective Serotonin Reuptake Inhibitor (SSRI) sertraline in the control of the Night Eating Syndrome (NES) and the unprecedented elevation in the level of serotonin transporter (SERT) binding in the midbrain of persons with NES. Our overall theory is that NES is associated with a syndrome-specific increase in SERT derived from a genetic vulnerability which is affected by life stress. This increased SERT activity produces a fall in post-synaptic serotonin levels. The investigators hypothesize that these decreased serotonin levels result in a significant phase delay in circadian food intake manifested by evening hyperphagia, nighttime ingestions and morning anorexia. SSRIs that block this increased SERT activity increase synaptic serotonin levels and restore the circadian rhythm of food intake.

Conditions

• Night Eating Syndrome

Interventions

Type	Name	Description
DRUG	escitalopram oxalate	The purpose of this study is to determine the effectiveness of the anti-depressant Lexapro in the treatment of the Night Eating Syndrome. An ADAM SPECT-CT study of SERT binding will be conducted which will compare SERT binding in 31 night eaters with that of 10 control subjects. The first procedure will be to assess SPECT-CT images of night eaters and controls following up our pilot SPECT study of night eaters and controls. Medication will be administered starting at 10 mg daily, with increase up to 20 mg, as indicated and tolerated, for up to three months. Visits will occur at baseline and weeks 1, 2, 4, 6, 8, 10, and 12.

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2011-07-25
• Last updated: 2020-07-15
• Results posted: 2017-05-09

Locations

1 site across 1 country: United States