Brain Imaging and Treatment Studies of the Night Eating Syndrome (NES)

University of Pennsylvania

Status and phase: Completed; Phase 3

Conditions: Night Eating Syndrome

Treatments: Drug: escitalopram oxalate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01401595

806753

Details and patient eligibility

About

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

Full 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.

Enrollment: 87 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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87 participants in 2 patient groups

Night Eaters

Experimental group

Description:

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.

Treatment:

Drug: escitalopram oxalate

Control Subjects

No Intervention group

Description:

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.