Brain Imaging and Treatment Studies of the Night Eating Syndrome (NES)
The purpose of this study is to determine the effectiveness of the anti-depressant Lexapro in the treatment of the Night Eating Syndrome.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Brain Imaging and Treatment Studies of the Night Eating Syndrome|
- Brain Imaging and SERT binding [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
The brain imaging performed before treatment (SPECT scan) is designed to determine if a measure, the serotonin transporter (SERT), is increased in the brain of persons with Night Eating Syndrome as compared to controls, and if this increase predicts the outcome of treatment for Night Eating Syndrome with Lexapro.
Outcome of treatment will be measured by self report questionnaires (The Night Eating Questionnaire, The Night Eating Symptom Scale, and The Eating Disorder Examination). A higher score on these measures is an indicator of disordered eating patterns.
- SERT Binding and Night Eating Symptoms [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
The second outcome will be the determination of the correlation between SERT binding and responses on the Night Eating Questionnaire (NEQ).
Subjects will complete the NEQ at their baseline visit, and at every treatment visit thereafter. The NEQ is a self report measure of night eating episodes. The NEQ will indicate whether or not Lexapro is having an effect on our patients' night eating symptoms.
|Study Start Date:||December 2009|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Experimental: Night Eaters
Subjects will be given a medical history, height and weight will be measured, and BMI calculated. Initial outpatient assessment will include diary measurement of food intake and nighttime awakenings (and associated food intake) together with psychological testing. For women, a pregnancy test will also be administered no more than 48 hours before SPECT-CT imaging and the beginning of Lexapro treatment. Lexapro treatment will last 12 weeks.
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 30 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.
Other Name: Lexapro
No Intervention: Control Subjects
At the beginning of the study, control subjects will be given a medical history, height and weight will be measured, and BMI calculated. Initial outpatient assessment will include diary measurement of food intake and nighttime awakenings (and associated food intake) together with psychological testing.
An ADAM SPECT or SPECT-CT study of SERT binding will be conducted which will compare SERT binding of the 10 control subjects with that of the 30 night eating subjects. The first procedure will be to assess SPECT or SPECT-CT images of night eaters and controls following up our pilot SPECT study of night eaters and controls.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01401595
|United States, Pennsylvania|
|The Center for Weight and Eating Disorders|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Kelly C Allison, PhD||University of Pennsylvania|