Clinical trial NCT01401595: Brain Imaging and Treatment Studies of the Night Eating Syndrome
Official title: Brain Imaging and Treatment Studies of the Night Eating Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Night Eating Syndrome
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2011-07-25
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Symptoms of NES
timeFrame: 12 weeks
Secondary outcomes:
measure: Nocturnal Ingestions
timeFrame: 12 weeks
measure: Night Eating Symptoms
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Center for Weight and Eating Disorders
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Kelly C Allison, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.