NES: Brain Imaging and Treatment Studies of the Night Eating Syndrome

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT01401595
• Collaborator: Forest Laboratories (Industry)
• Enrollment: 87
• Location: 1
• Arms: 2
• Duration (Months): 21
• Patients Per Site Per Month: 4.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Night Eating Syndrome	Drug: escitalopram oxalate	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 87 participants
• 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
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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.

Outcome Measures

Primary Outcome Measures

1. Change in Symptoms of NES [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

1. Nocturnal Ingestions [12 weeks]

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

2. Night Eating Symptoms [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• The Center for Weight and Eating Disorders

Publications

None provided.

• Responsible Party: Kelly Allison, Assistant Professor, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT01401595
• Other Study ID Numbers: 806753
• First Posted: Jul 25, 2011
• Last Update Posted: Jul 15, 2020
• Last Verified: Jun 1, 2020

• Additional relevant MeSH terms: Syndrome; Night Eating Syndrome; Dexetimide; Citalopram

Study Results

Participant Flow

Arm/Group Title	Night Eaters	Control Subjects
Arm/Group Description	Subjects were given a medical history, and height and weight was measured. Initial outpatient assessment included diary measurement of food intake and nighttime awakenings (and associated food intake) together with psychological testing. For women, a pregnancy test was also administered no more than 48 hours before SPECT-CT imaging and the beginning of Lexapro treatment. Lexapro treatment lasted 12 weeks. 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 was conducted which will compare SERT binding in 30 night eaters with that of 10 controls. The first procedure assessed SPECT-CT images of night eaters and controls. Medication was administered starting at 10 mg daily, with increases up to 20 mg, as indicated and tolerated, for up to three months. Visits occured at baseline and weeks 1, 2, 4, 6, 8, 10, and 12.	At the beginning of the study, control subjects were given a medical history, height and weight was measured, and BMI calculated. Initial outpatient assessment included diary measurement of food intake and nighttime awakenings (and associated food intake) together with psychological testing. An ADAM SPECT-CT study of SERT binding was conducted which will compare SERT binding of the 10 control subjects with that of the 30 night eating subjects to assess SPECT-CT images of night eaters and controls following up our pilot SPECT study of night eaters and controls.
Period Title: Recruitment and Screening
STARTED	75	12
COMPLETED	32	10
NOT COMPLETED	43	2
Period Title: Recruitment and Screening
STARTED	32	10
COMPLETED	18	10
NOT COMPLETED	14	0

Baseline Characteristics

Arm/Group Title	Night Eaters	Control Subjects	Total
Arm/Group Description	31 participants screened and diagnosed with NES attended the baseline treatment session and at least one follow-up appointment.	10 control participants completed the baseline screening and SPECT scans.	Total of all reporting groups
Overall Participants	31	10	41
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	31 100%	10 100%	41 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	21 67.7%	6 60%	27 65.9%
Male	10 32.3%	4 40%	14 34.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 3.2%	2 20%	3 7.3%
Not Hispanic or Latino	29 93.5%	7 70%	36 87.8%
Unknown or Not Reported	1 3.2%	1 10%	2 4.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 3.2%	0 0%	1 2.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	12 38.7%	4 40%	16 39%
White	15 48.4%	4 40%	19 46.3%
More than one race	2 6.5%	1 10%	3 7.3%
Unknown or Not Reported	1 3.2%	1 10%	2 4.9%
Region of Enrollment (participants) [Number]
United States	31 100%	10 100%	41 100%

Outcome Measures

1. Primary Outcome

Title	Change in Symptoms of NES
Description	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.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Night Eating Syndrome Open Label Escitalopram Treatment	Controls
Arm/Group Description	All subjects with NES participated in the open label treatment with escitalopram, although of the 32 participants, 1 did not return after her initial medication visit. As it is unknown if this participants started the medication, only the 31 participants who returned to a second visit or more were included in the analysis	The control participants did not participate in the treatment part of the study - only the baseline SPECT scans.
Measure Participants	31	10
baseline %calories consumed after dinner	46.1 (3.0)	11.8 (2.4)
treatment end %calories after dinner	17.4 (3.5)	NA (NA)

2. Secondary Outcome

Title	Nocturnal Ingestions
Description	Number of nocturnal ingestions (waking and having something to eat) were reported at each visit.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Night Eating Syndrome Open Label Escitalopram Treatment	Controls
Arm/Group Description	All NES subjects received the open label escitalopram treatment	The controls did not participate in the escitalopram treatment portion of the study. The just completed the baseline screening and SPECT scan.
Measure Participants	31	10
baseline nocturnal ingestions/week	5.8 (0.5)	0.0 (0.0)
treatment end nocturnal ingestions/week	1.2 (0.6)	NA (NA)

3. Secondary Outcome

Title	Night Eating Symptoms
Description	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.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Night Eating Syndrome Open Label Escitalopram Treatment	Controls
Arm/Group Description	All NES subjects received the open label escitalopram treatment	The controls did not participate in the escitalopram treatment portion of the study. The just completed the baseline screening and SPECT scan.
Measure Participants	31	10
Baseline Night Eating Symptom Scale	30.2 (1.3)	NA (NA)
treatment end night eating symptom scale	15.2 (1.5)	NA (NA)

Adverse Events

Time Frame	Duration of the study - 12 weeks, open label with escitalopram oxalate
Arm/Group Title	Night Eating Syndrome Open Label Treatment Group
Arm/Group Description	Only the 32 participants with NES participated in the open label escitalopram treatment trial. One participant did not return after the first visit, and it is unknown if she ever started the medication. Thus 31 participants were included in the statistical analyses.
All Cause Mortality
	Night Eating Syndrome Open Label Treatment Group
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Night Eating Syndrome Open Label Treatment Group
	Affected / at Risk (%)	# Events
Total	0/31 (0%)
Other (Not Including Serious) Adverse Events
	Night Eating Syndrome Open Label Treatment Group
	Affected / at Risk (%)	# Events
Total	5/31 (16.1%)
Gastrointestinal disorders
nausea	5/31 (16.1%)
diarrhea	2/31 (6.5%)
General disorders
dry mouth	3/31 (9.7%)
increased sweating	2/31 (6.5%)
Nervous system disorders
drowsiness	4/31 (12.9%)
headache	2/31 (6.5%)
mental cloudiness	2/31 (6.5%)
Reproductive system and breast disorders
impotence/low libido	2/31 (6.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.