Brain Imaging and Treatment Studies of the Night Eating Syndrome (NES)
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|ClinicalTrials.gov Identifier: NCT01401595|
Recruitment Status : Completed
First Posted : July 25, 2011
Results First Posted : May 9, 2017
Last Update Posted : May 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Night Eating Syndrome||Drug: escitalopram oxalate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||87 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Brain Imaging and Treatment Studies of the Night Eating Syndrome|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
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 escitalopram oxalate (Lexapro) treatment. Escitalopram oxalate (Lexapro) open-label treatment will last 12 weeks. Dosing will start at 10 mg and increase to 20 mg per day flexibly. Treatment will be discontinued starting at 12 weeks under the supervision of our study physician.
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.
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.
- Change in Symptoms of NES [ Time Frame: 12 weeks ]Outcome of treatment will be measured by self report questionnaire, the Night Eating Symptom Scale ( higher score indicates worse symptoms). The percentage of calories consumed after dinner was estimated by recall at each treatment visit, as compared to their baseline % of intake after dinner, which was calculated through food diaries. The number of nocturnal ingestions (waking during the night and eating) per week was also recalled at each treatment visit.
- Night Eating Symptoms [ Time Frame: 12 weeks ]Number of nocturnal ingestions (waking and having something to eat) were reported at each visit.
- Night Eating Symptoms [ Time Frame: 12 weeks ]
The responses on the Night Eating Symptom Scale (NESS) will be examined over time.
Subjects will complete the NESS at their baseline visit, and at every treatment visit thereafter. The Night Eating Symptom Scale-II (NESS-II) (Lundgren, Allison, Vinai, & Gluck, 2012) is a 14-item questionnaire (possible range of 0-56, with higher scores indicating more severe symptoms) that assesses the presence of NES features over the course of the previous week. The NESS will indicate whether or not escitalopram is having an effect on our participants' night eating symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|