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

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Kelly Allison, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01401595
First received: May 23, 2011
Last updated: March 28, 2017
Last verified: March 2017
  Purpose
The purpose of this study is to determine the effectiveness of the anti-depressant Lexapro in the treatment of the Night Eating Syndrome.

Condition Intervention Phase
Night Eating Syndrome Drug: escitalopram oxalate Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Brain Imaging and Treatment Studies of the Night Eating Syndrome

Resource links provided by NLM:


Further study details as provided by Kelly Allison, University of Pennsylvania:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Night Eating Symptoms [ Time Frame: 12 weeks ]
    Number of nocturnal ingestions (waking and having something to eat) were reported at each visit.

  • 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.



Enrollment: 87
Study Start Date: December 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Night Eaters
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.
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.
Other Name: Lexapro
No Intervention: Control Subjects

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.


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

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01401595

Locations
United States, Pennsylvania
The Center for Weight and Eating Disorders
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Forest Laboratories
Investigators
Principal Investigator: Kelly C Allison, PhD University of Pennsylvania
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kelly Allison, Assistant Professor, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01401595     History of Changes
Other Study ID Numbers: 806753
Study First Received: May 23, 2011
Results First Received: December 1, 2014
Last Updated: March 28, 2017

Additional relevant MeSH terms:
Syndrome
Disease
Pathologic Processes
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on August 18, 2017