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Completed

NCT Number: NCT01401595

Brain Imaging and Treatment Studies of the Night Eating Syndrome

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

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Key information

Conditions

Night Eating Syndrome Feeding and Eating Disorders Mental Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Center for Weight and Eating Disorders

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Escitalopram Oxalate

Drug

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 names: Lexapro

Primary outcomes

  1. 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.

Secondary outcomes

  1. Nocturnal Ingestions

    Time frame: 12 weeks

    Number of nocturnal ingestions (waking and having something to eat) were reported at each visit.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Forest Laboratories

Registry information

Acronym: NES

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 25, 2011
Registry last updated
Jul 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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