Brain Imaging and Treatment Studies of the Night Eating Syndrome

Night Eating Syndrome Clinical Trial

— NES  

Official title:

Brain Imaging and Treatment Studies of the Night Eating Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01401595
• Other study ID #: 806753
• Status: Completed
• Phase: Phase 3
• Start date: December 2009
• Est. completion date: September 2011

Study information

• Verified date: June 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• men and women suffering from NES

• ages 18 to 70 years

• BMI greater than 18.5 kg/m2

Exclusion Criteria:

• Children or adolescents <18 years

• persons older than 70

• patients with diabetes mellitus

• thyroid disease and other endocrine and metabolic disorders

• use within the past month of any psychotropic medication, oral steroids, diuretics or hypnotics

• current anorexia nervosa or bulimia nervosa

• participation in an organized weight reduction program

• use of antiobesity medication

• an occupation that involves night shifts or other unusual time requirements -Major Depressive Disorder (judged severe)

• Bipolar Disorder

• suicidal risk

• current or past psychosis

• substance use or abuse disorder within the past 6 months

Related Conditions & MeSH terms

• Night Eating Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	The Center for Weight and Eating Disorders	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Nocturnal Ingestions	Number of nocturnal ingestions (waking and having something to eat) were reported at each visit.	12 weeks
Secondary	Night Eating Symptoms	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.	12 weeks

External Links

•   The Center for Weight and Eating Disorders