Night Eating Syndrome
Conditions
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.
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.
Interventions
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.
Sponsors
Forest Laboratories
University of Pennsylvania
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Nocturnal Ingestions | 12 weeks | Number of nocturnal ingestions (waking and having something to eat) were reported at each visit. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Night Eaters 31 participants screened and diagnosed with NES attended the baseline treatment session and at least one follow-up appointment. | 31 |
| Control Subjects 10 control participants completed the baseline screening and SPECT scans. | 10 |
| Total | 41 |
Baseline characteristics
| Characteristic | Night Eaters | Control Subjects | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 10 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 7 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 4 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 15 Participants | 4 Participants | 19 Participants |
| Region of Enrollment United States | 31 participants | 10 participants | 41 participants |
| Sex: Female, Male Female | 21 Participants | 6 Participants | 27 Participants |
| Sex: Female, Male Male | 10 Participants | 4 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
Primary
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.
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Night Eating Syndrome Open Label Escitalopram Treatment | Change in Symptoms of NES | baseline %calories consumed after dinner | 46.1 percentage of calories after dinner | Standard Error 3 |
| Night Eating Syndrome Open Label Escitalopram Treatment | Change in Symptoms of NES | treatment end %calories after dinner | 17.4 percentage of calories after dinner | Standard Error 3.5 |
| Controls | Change in Symptoms of NES | baseline %calories consumed after dinner | 11.8 percentage of calories after dinner | Standard Error 2.4 |
| Controls | Change in Symptoms of NES | treatment end %calories after dinner | NA percentage of calories after dinner | — |
Secondary
Night Eating Symptoms
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Night Eating Syndrome Open Label Escitalopram Treatment | Night Eating Symptoms | Baseline Night Eating Symptom Scale | 30.2 units on a scale | Standard Error 1.3 |
| Night Eating Syndrome Open Label Escitalopram Treatment | Night Eating Symptoms | treatment end night eating symptom scale | 15.2 units on a scale | Standard Error 1.5 |
| Controls | Night Eating Symptoms | Baseline Night Eating Symptom Scale | NA units on a scale | — |
| Controls | Night Eating Symptoms | treatment end night eating symptom scale | NA units on a scale | — |
Secondary
Nocturnal Ingestions
Number of nocturnal ingestions (waking and having something to eat) were reported at each visit.
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Night Eating Syndrome Open Label Escitalopram Treatment | Nocturnal Ingestions | treatment end nocturnal ingestions/week | 1.2 units on a scale | Standard Error 0.6 |
| Night Eating Syndrome Open Label Escitalopram Treatment | Nocturnal Ingestions | baseline nocturnal ingestions/week | 5.8 units on a scale | Standard Error 0.5 |
| Controls | Nocturnal Ingestions | baseline nocturnal ingestions/week | 0.0 units on a scale | Standard Error 0 |
| Controls | Nocturnal Ingestions | treatment end nocturnal ingestions/week | NA units on a scale | — |