NCT01401595|CompletedPhase 3ResultsDMC
Brain Imaging and Treatment Studies of the Night Eating Syndrome
NES
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Sponsor study identifier
interventional
87
1 country
1
Study Start
December 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2011
Actual (reported)Study Completion
September 2011
Actual (reported)The purpose of this study is to determine the effectiveness of the anti-depressant Lexapro in the treatment of the Night Eating Syndrome.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2011
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2009
Date type not reportedThis date has not been verified as actual or estimated.
May 23, 2011
Actual (reported)July 25, 2011
Actual (reported)September 2011
Actual (reported)September 2011
Actual (reported)May 9, 2017
Actual (reported)Change in Symptoms of NES
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.
12 weeks
Nocturnal Ingestions
12 weeks
Night Eating Symptoms
12 weeks
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.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The Center for Weight and Eating Disorders
Philadelphia, Pennsylvania, 19104, United States
Allison KC, Studt SK, Berkowitz RI, Hesson LA, Moore RH, Dubroff JG, Newberg A, Stunkard AJ. An open-label efficacy trial of escitalopram for night eating syndrome. Eat Behav. 2013 Apr;14(2):199-203. doi: 10.1016/j.eatbeh.2013.02.001. Epub 2013 Mar 5.
Kelly C Allison, PhD
University of Pennsylvania
87 participants (actual enrollment reported by the registry).
First Submitted
May 23, 2011
First Posted
July 25, 2011
Study Start
December 2009
Date type not reportedThis date has not been verified as actual or estimated.
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s of Escitalopram Oxalate Tablets Under Fasting Condition
Contact the study team to confirm eligibility.
Primary Completion
September 2011
Actual (reported)Study Completion
September 2011
Actual (reported)Last Updated
July 15, 2020
Results First Posted
May 9, 2017
Record last verified: 2020-06
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Source: ClinicalTrials.gov.
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