Brain Imaging and Treatment Studies of the Night Eating Syndrome

NCT01401595 | Completed Phase 3 Results DMC

• 1 other identifier: 806753
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Night Eating Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Nocturnal Ingestions

  12 weeks

• Night Eating Symptoms

  12 weeks

Study Arms (2)

Night Eaters

EXPERIMENTAL

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

Control Subjects

NO INTERVENTION

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.

Interventions

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.

Also known as: Lexapro

Night Eaters

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men and women suffering from NES
• ages 18 to 70 years
• BMI greater than 18.5 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Forest Laboratories: collaborator

Study Sites (1)

The Center for Weight and Eating Disorders

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 23557820 DERIVED

Related Links

• The Center for Weight and Eating Disorders

MeSH Terms

Conditions

Night Eating Syndrome

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Kelly C. Allison, Ph.D.
• Organization: Perelman School of Medicine at the University of Pennsylvania

kca@mail.med.upenn.edu

215-898-2823

Study Officials

• Kelly C Allison, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 23, 2011
• First Posted: July 25, 2011
• Study Start: December 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 15, 2020
• Results First Posted: May 9, 2017

Record last verified: 2020-06

Locations

US (1)