Trial Outcomes & Findings for Brain Imaging and Treatment Studies of the Night Eating Syndrome (NCT NCT01401595)
NCT ID: NCT01401595
Last Updated: 2020-07-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
87 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-07-15
Participant Flow
Participant milestones
| Measure |
Night Eaters
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.
|
Control Subjects
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.
|
|---|---|---|
|
Recruitment and Screening
STARTED
|
75
|
12
|
|
Recruitment and Screening
COMPLETED
|
32
|
10
|
|
Recruitment and Screening
NOT COMPLETED
|
43
|
2
|
|
Imaging and Treatment (for NE Arm)
STARTED
|
32
|
10
|
|
Imaging and Treatment (for NE Arm)
COMPLETED
|
18
|
10
|
|
Imaging and Treatment (for NE Arm)
NOT COMPLETED
|
14
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Brain Imaging and Treatment Studies of the Night Eating Syndrome
Baseline characteristics by cohort
| Measure |
Night Eaters
n=31 Participants
31 participants screened and diagnosed with NES attended the baseline treatment session and at least one follow-up appointment.
|
Control Subjects
n=10 Participants
10 control participants completed the baseline screening and SPECT scans.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
10 participants
n=7 Participants
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksOutcome 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.
Outcome measures
| Measure |
Night Eating Syndrome Open Label Escitalopram Treatment
n=31 Participants
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
|
Controls
n=10 Participants
The control participants did not participate in the treatment part of the study - only the baseline SPECT scans.
|
|---|---|---|
|
Change in Symptoms of NES
baseline %calories consumed after dinner
|
46.1 percentage of calories after dinner
Standard Error 3.0
|
11.8 percentage of calories after dinner
Standard Error 2.4
|
|
Change in Symptoms of NES
treatment end %calories after dinner
|
17.4 percentage of calories after dinner
Standard Error 3.5
|
NA percentage of calories after dinner
Standard Error NA
Controls did not participate in the escitalopram treatment.
|
SECONDARY outcome
Timeframe: 12 weeksNumber of nocturnal ingestions (waking and having something to eat) were reported at each visit.
Outcome measures
| Measure |
Night Eating Syndrome Open Label Escitalopram Treatment
n=31 Participants
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
|
Controls
n=10 Participants
The control participants did not participate in the treatment part of the study - only the baseline SPECT scans.
|
|---|---|---|
|
Nocturnal Ingestions
baseline nocturnal ingestions/week
|
5.8 units on a scale
Standard Error 0.5
|
0.0 units on a scale
Standard Error 0.0
|
|
Nocturnal Ingestions
treatment end nocturnal ingestions/week
|
1.2 units on a scale
Standard Error 0.6
|
NA units on a scale
Standard Error NA
Controls did not participate in the escitalopram treatment.
|
SECONDARY outcome
Timeframe: 12 weeksThe 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.
Outcome measures
| Measure |
Night Eating Syndrome Open Label Escitalopram Treatment
n=31 Participants
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
|
Controls
n=10 Participants
The control participants did not participate in the treatment part of the study - only the baseline SPECT scans.
|
|---|---|---|
|
Night Eating Symptoms
treatment end night eating symptom scale
|
15.2 units on a scale
Standard Error 1.5
|
NA units on a scale
Standard Error NA
The controls did not participate in the escitalopram treatment.
|
|
Night Eating Symptoms
Baseline Night Eating Symptom Scale
|
30.2 units on a scale
Standard Error 1.3
|
NA units on a scale
Standard Error NA
The NESS was administered at the first treatment visit, not at the baseline screening/characterization visit, so the controls did not complete this measure.
|
Adverse Events
Night Eating Syndrome Open Label Treatment Group
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Night Eating Syndrome Open Label Treatment Group
n=31 participants at risk
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.
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|---|---|
|
Gastrointestinal disorders
nausea
|
16.1%
5/31 • Duration of the study - 12 weeks, open label with escitalopram oxalate
|
|
Nervous system disorders
drowsiness
|
12.9%
4/31 • Duration of the study - 12 weeks, open label with escitalopram oxalate
|
|
General disorders
dry mouth
|
9.7%
3/31 • Duration of the study - 12 weeks, open label with escitalopram oxalate
|
|
General disorders
increased sweating
|
6.5%
2/31 • Duration of the study - 12 weeks, open label with escitalopram oxalate
|
|
Reproductive system and breast disorders
impotence/low libido
|
6.5%
2/31 • Duration of the study - 12 weeks, open label with escitalopram oxalate
|
|
Nervous system disorders
headache
|
6.5%
2/31 • Duration of the study - 12 weeks, open label with escitalopram oxalate
|
|
Nervous system disorders
mental cloudiness
|
6.5%
2/31 • Duration of the study - 12 weeks, open label with escitalopram oxalate
|
|
Gastrointestinal disorders
diarrhea
|
6.5%
2/31 • Duration of the study - 12 weeks, open label with escitalopram oxalate
|
Additional Information
Kelly C. Allison, Ph.D.
Perelman School of Medicine at the University of Pennsylvania
Phone: 215-898-2823
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place