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Escitalopram Treatment of Night Eating Syndrome

Escitalopram Treatment of Night Eating Syndrome: a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00636649
Enrollment
40
Registered
2008-03-14
Start date
2008-10-31
Completion date
2011-07-31
Last updated
2016-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Night Eating Syndrome

Keywords

Eating disorder

Brief summary

Night-Eating Syndrome (NES) is an eating disorder characterised by excessive eating at night, sleep disturbance and morning anorexia. This 12-week study examines the effect of escitalopram on symptoms of NES.

Interventions

DRUGEscitalopram

10-20 mg

DRUGPlacebo

Placebo

Sponsors

St. Louis University
CollaboratorOTHER
Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Age 18-70 years * Presence of NES * BMI 25-50

Exclusion criteria

* History of schizophrenia or other psychoses * History of bipolar disorder, anorexia nervosa, bulimia, binge eating disorder * Current major depressive disorder * Suicidal ideation * Psychotropic drugs in the past month * Drugs or herbal remedies that significantly affect body weight, current participation in a weight loss program, currently following a specialized diet (e.g., Atkins, Zone, etc) * Lack of benefit with SSRI treatment for NES * Serious or unstable medical illness * Allergy or hypersensitivity to escitalopram * Pregnant, breast-feeding, or planning pregnancy in the next six months.

Design outcomes

Primary

MeasureTime frameDescription
Night Eating Questionnairebaseline, 12 weeksThe Night Eating Questionnaire (NEQ) is a 14-item self-report scale designed to assess the symptoms of NES including nocturnal ingestions, evening hyperphagia, morning anorexia, and mood/sleep. Scores range from 0-56, with higher scores indicative of greater severity. The NEQ has an acceptable internal consistency reliability (.70). A cut-score of 25 has been shown to yield a positive predictive value of .62.

Secondary

MeasureTime frameDescription
Change in Coping Inventory for Stressful Situations (CISS)Baseline, 12 weeksTASK = task-oriented coping; EMOT = emotion-oriented coping; AVD = avoidance-focused coping; Avoidance-focused coping may be divided into two subtypes: DIS = distraction-oriented coping; SOC = social diversion-oriented coping. CISS is a 48 item self-report measure used to measure responses to stressful situations rated for frequency on a 5 point Likert scales ranging from1, not at all to 5, very much. This measure assesses three coping styles: Task-Oriented, Emotion-Oriented, and two types of Avoidance-Oriented coping (Social Diversion and Distraction). There are 16 items on each of the primary scales (task, emotion, avoidance) and 5 on social diversion and 8 on distraction. Scores are summed for each subscale and then converted to gender-corrected t-scores with a mean of 50 and a standard deviation of 10. T-scores on the CISS range from a low of 25 (1st percentile) to 75 (99th percentile). Higher scores indicate more adaptive levels of coping.
Change in Perceived Stress Scale (PSS)12 weeksThe Perceived Stress Scale (PSS) measures the overall level of stress. This instrument contains 14 items accessing overall appraisals of stress in the past month. Minimum score (best value)=0. Maximum score (worst value)=56. A higher score indicates greater stress.
Change in Three Factor Eating Questionnaire (TFEQ)Baseline, 12 weeksThe TFEQ (also known as the Eating Inventory) measures dimensions of eating behavior including cognitive restraint of eating, disinhibition, and hunger using a combination of dichotomous questions, 4-point likert scales, and one 5-point likert scale. Restraint is comprised of the responses to 21 questions with possible scores ranging from 0 to 21 (Low scores for all scales indicate an uninhibited eating behavior.). Disinhibition is comprised of the responses to 16 questions with possible scores ranging from 0 to 16 (High scores indicate an uninhibited eating behavior strongly depending on external cues). Hunger is comprised of the responses to 14 questions with possible scores ranging from 0 to 14 ( Low scores indicate an eating behavior strongly depending on feelings of hunger.). RES = Restraint Subscale; DIS = Disinhibition Subscale; HUN = Hunger Subscale
Number of Participants With a Clinical Global Impression - Improvement (CGI-I) Score ≤ 212 weeksThe CGI-I scale is a clinician rating of overall therapeutic effect ranging from 1 (very much improved) to 7 (very much worse) since commencing treatment.
Change in Lipid PanelBaseline,12 weeks
Change in Beck Depression Inventory II (BDI-II) ScoreBaseline, 12 weeksThe BDI-II is a 21-item self-report questionnaire designed to measure cognitive, somatic, and behavioral aspects of depression. Scores range from 0 to 63, with higher scores indicating a higher level of depressive symptoms.
Change in GlucoseBaseline, 12 Week
Change in WeightBaseline, 12 week
Number of Participants Who no Longer Meet the NESHI CriteriaWeek 12The Night Eating Syndrome History and Inventory (NESHI) is an unpublished, semistructured interview used to confirm a diagnosis of NES. It assesses a typical 24-hour food intake, including a recall of all meals and snacks, and sleeping patterns. Based on the recall of all meals and snacks, the interviewer judged whether ≥25% of the daily caloric intake was eaten after the evening meal and how often nocturnal ingestions occurred. The NEQ items were reviewed and informed by the dietary recall during the interview, and a new total score was tallied. A final score of ≥25 for the NEQ items, as reviewed during the NESHI, was used as the criterion for NES.
Number of Participants Who Had a 50% Reduction in NEQ ScoresWeek 12The Night Eating Questionnaire (NEQ) is a 14 item self-report scale designed to assess the symptoms of NES including nocturnal ingestions, evening hypcrphagia, morning anorexia, and mood/slccp. Scores range from 0 to 56, with higher scores indicative of greater severity.
Change in Beck Anxiety Inventory (BAI) ScoreBaseline, 12 weeksThe Beck Anxiety Inventory (BAI) is a 21-item self-report measure of anxiety. Scores range from 0 to 63, with higher scores indicative of higher levels of anxiety.

Countries

United States

Participant flow

Recruitment details

This study was conducted at Duke University Medical Center and Saint Louis University between 2008 and 2010.

Participants by arm

ArmCount
Escitalopram20
Placebo20
Total40

Baseline characteristics

CharacteristicPlaceboEscitalopramTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
20 Participants20 Participants40 Participants
Age, Continuous44.8 years
STANDARD_DEVIATION 12.3
45.2 years
STANDARD_DEVIATION 13.7
45.0 years
STANDARD_DEVIATION 13
Region of Enrollment
United States
20 participants20 participants40 participants
Sex: Female, Male
Female
10 Participants11 Participants21 Participants
Sex: Female, Male
Male
10 Participants9 Participants19 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
9 / 207 / 20
serious
Total, serious adverse events
0 / 200 / 20

Outcome results

Primary

Night Eating Questionnaire

The Night Eating Questionnaire (NEQ) is a 14-item self-report scale designed to assess the symptoms of NES including nocturnal ingestions, evening hyperphagia, morning anorexia, and mood/sleep. Scores range from 0-56, with higher scores indicative of greater severity. The NEQ has an acceptable internal consistency reliability (.70). A cut-score of 25 has been shown to yield a positive predictive value of .62.

Time frame: baseline, 12 weeks

Population: Data were analyzed as intent-to-treat with all 40 patients included in the analysis. Primary endpoint was change in the NEQ total score, i.e., difference between values between Week 12 (study exit) and baseline. Analysis of covariance was the primary statistical procedure with baseline NEQ score and baseline BMI as covariates.

ArmMeasureValue (MEAN)Dispersion
EscitalopramNight Eating Questionnaire-13.0 units on a scaleStandard Error 1.6
PlaceboNight Eating Questionnaire-10.6 units on a scaleStandard Error 2.2
Secondary

Change in Beck Anxiety Inventory (BAI) Score

The Beck Anxiety Inventory (BAI) is a 21-item self-report measure of anxiety. Scores range from 0 to 63, with higher scores indicative of higher levels of anxiety.

Time frame: Baseline, 12 weeks

ArmMeasureValue (MEAN)Dispersion
EscitalopramChange in Beck Anxiety Inventory (BAI) Score-1.5 units on a scaleStandard Error 0.8
PlaceboChange in Beck Anxiety Inventory (BAI) Score-1.8 units on a scaleStandard Error 0.9
Secondary

Change in Beck Depression Inventory II (BDI-II) Score

The BDI-II is a 21-item self-report questionnaire designed to measure cognitive, somatic, and behavioral aspects of depression. Scores range from 0 to 63, with higher scores indicating a higher level of depressive symptoms.

Time frame: Baseline, 12 weeks

ArmMeasureValue (MEAN)Dispersion
EscitalopramChange in Beck Depression Inventory II (BDI-II) Score-2.4 units on a scaleStandard Error 1.2
PlaceboChange in Beck Depression Inventory II (BDI-II) Score-3.5 units on a scaleStandard Error 1.5
Secondary

Change in Coping Inventory for Stressful Situations (CISS)

TASK = task-oriented coping; EMOT = emotion-oriented coping; AVD = avoidance-focused coping; Avoidance-focused coping may be divided into two subtypes: DIS = distraction-oriented coping; SOC = social diversion-oriented coping. CISS is a 48 item self-report measure used to measure responses to stressful situations rated for frequency on a 5 point Likert scales ranging from1, not at all to 5, very much. This measure assesses three coping styles: Task-Oriented, Emotion-Oriented, and two types of Avoidance-Oriented coping (Social Diversion and Distraction). There are 16 items on each of the primary scales (task, emotion, avoidance) and 5 on social diversion and 8 on distraction. Scores are summed for each subscale and then converted to gender-corrected t-scores with a mean of 50 and a standard deviation of 10. T-scores on the CISS range from a low of 25 (1st percentile) to 75 (99th percentile). Higher scores indicate more adaptive levels of coping.

Time frame: Baseline, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
EscitalopramChange in Coping Inventory for Stressful Situations (CISS)CISS-EMOT1.25 t-scoresStandard Error 2.82
EscitalopramChange in Coping Inventory for Stressful Situations (CISS)CISS-DIS3.40 t-scoresStandard Error 2.42
EscitalopramChange in Coping Inventory for Stressful Situations (CISS)CISS-AVD0 t-scoresStandard Error 3.31
EscitalopramChange in Coping Inventory for Stressful Situations (CISS)CISS-SOC-2.45 t-scoresStandard Error 2.08
EscitalopramChange in Coping Inventory for Stressful Situations (CISS)CISS-TASK2.35 t-scoresStandard Error 3.5
PlaceboChange in Coping Inventory for Stressful Situations (CISS)CISS-SOC2.15 t-scoresStandard Error 1.62
PlaceboChange in Coping Inventory for Stressful Situations (CISS)CISS-TASK1.75 t-scoresStandard Error 1.37
PlaceboChange in Coping Inventory for Stressful Situations (CISS)CISS-EMOT-1.45 t-scoresStandard Error 1.37
PlaceboChange in Coping Inventory for Stressful Situations (CISS)CISS-AVD2.60 t-scoresStandard Error 1.1
PlaceboChange in Coping Inventory for Stressful Situations (CISS)CISS-DIS1.95 t-scoresStandard Error 1.33
Comparison: CISS-TASKp-value: 0.993ANCOVA
Comparison: CISS-EMOTp-value: 0.185ANCOVA
Comparison: CISS-DISp-value: 0.196ANCOVA
Comparison: CISS-AVDp-value: 0.759ANCOVA
Comparison: CISS-SOCp-value: 0.396ANCOVA
Secondary

Change in Glucose

Time frame: Baseline, 12 Week

ArmMeasureValue (MEAN)Dispersion
EscitalopramChange in Glucose3.9 mg/dLStandard Error 6.3
PlaceboChange in Glucose7.6 mg/dLStandard Error 4.6
Secondary

Change in Lipid Panel

Time frame: Baseline,12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
EscitalopramChange in Lipid PanelHDL-2.8 mg/dLStandard Error 1.8
EscitalopramChange in Lipid PanelLDL-3.9 mg/dLStandard Error 4.4
EscitalopramChange in Lipid PanelTriglycerides27.5 mg/dLStandard Error 26.3
EscitalopramChange in Lipid Paneltotal cholesterol-4.5 mg/dLStandard Error 5.2
PlaceboChange in Lipid Paneltotal cholesterol-2.3 mg/dLStandard Error 4.5
PlaceboChange in Lipid PanelHDL-2.2 mg/dLStandard Error 1.8
PlaceboChange in Lipid PanelTriglycerides-14.0 mg/dLStandard Error 15.6
PlaceboChange in Lipid PanelLDL2.8 mg/dLStandard Error 4.5
Secondary

Change in Perceived Stress Scale (PSS)

The Perceived Stress Scale (PSS) measures the overall level of stress. This instrument contains 14 items accessing overall appraisals of stress in the past month. Minimum score (best value)=0. Maximum score (worst value)=56. A higher score indicates greater stress.

Time frame: 12 weeks

Population: Participants who completed PSS assessment at baseline and week 12.

ArmMeasureValue (MEAN)Dispersion
EscitalopramChange in Perceived Stress Scale (PSS)-0.55 units on a scaleStandard Error 1.42
PlaceboChange in Perceived Stress Scale (PSS)-2.11 units on a scaleStandard Error 1.39
p-value: 0.579ANCOVA
Secondary

Change in Three Factor Eating Questionnaire (TFEQ)

The TFEQ (also known as the Eating Inventory) measures dimensions of eating behavior including cognitive restraint of eating, disinhibition, and hunger using a combination of dichotomous questions, 4-point likert scales, and one 5-point likert scale. Restraint is comprised of the responses to 21 questions with possible scores ranging from 0 to 21 (Low scores for all scales indicate an uninhibited eating behavior.). Disinhibition is comprised of the responses to 16 questions with possible scores ranging from 0 to 16 (High scores indicate an uninhibited eating behavior strongly depending on external cues). Hunger is comprised of the responses to 14 questions with possible scores ranging from 0 to 14 ( Low scores indicate an eating behavior strongly depending on feelings of hunger.). RES = Restraint Subscale; DIS = Disinhibition Subscale; HUN = Hunger Subscale

Time frame: Baseline, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
EscitalopramChange in Three Factor Eating Questionnaire (TFEQ)TFEQ-RES2.95 units on a scaleStandard Error 1.12
EscitalopramChange in Three Factor Eating Questionnaire (TFEQ)TFEQ-DIS-0.85 units on a scaleStandard Error 0.73
EscitalopramChange in Three Factor Eating Questionnaire (TFEQ)TFEQ-HUN-1.60 units on a scaleStandard Error 0.76
PlaceboChange in Three Factor Eating Questionnaire (TFEQ)TFEQ-RES1.85 units on a scaleStandard Error 0.56
PlaceboChange in Three Factor Eating Questionnaire (TFEQ)TFEQ-DIS-1.50 units on a scaleStandard Error 0.61
PlaceboChange in Three Factor Eating Questionnaire (TFEQ)TFEQ-HUN-1.75 units on a scaleStandard Error 0.63
Comparison: TFEQ-RESp-value: 0.225ANCOVA
Comparison: TFEQ-DISp-value: 0.498ANCOVA
Comparison: TFEQ-HUNp-value: 0.724ANCOVA
Secondary

Change in Weight

Time frame: Baseline, 12 week

ArmMeasureValue (MEAN)Dispersion
EscitalopramChange in Weight-0.43 kgStandard Error 0.7
PlaceboChange in Weight1.12 kgStandard Error 0.6
Secondary

Number of Participants Who Had a 50% Reduction in NEQ Scores

The Night Eating Questionnaire (NEQ) is a 14 item self-report scale designed to assess the symptoms of NES including nocturnal ingestions, evening hypcrphagia, morning anorexia, and mood/slccp. Scores range from 0 to 56, with higher scores indicative of greater severity.

Time frame: Week 12

ArmMeasureValue (NUMBER)
EscitalopramNumber of Participants Who Had a 50% Reduction in NEQ Scores7 participants
PlaceboNumber of Participants Who Had a 50% Reduction in NEQ Scores6 participants
Secondary

Number of Participants Who no Longer Meet the NESHI Criteria

The Night Eating Syndrome History and Inventory (NESHI) is an unpublished, semistructured interview used to confirm a diagnosis of NES. It assesses a typical 24-hour food intake, including a recall of all meals and snacks, and sleeping patterns. Based on the recall of all meals and snacks, the interviewer judged whether ≥25% of the daily caloric intake was eaten after the evening meal and how often nocturnal ingestions occurred. The NEQ items were reviewed and informed by the dietary recall during the interview, and a new total score was tallied. A final score of ≥25 for the NEQ items, as reviewed during the NESHI, was used as the criterion for NES.

Time frame: Week 12

ArmMeasureValue (NUMBER)
EscitalopramNumber of Participants Who no Longer Meet the NESHI Criteria16 participants
PlaceboNumber of Participants Who no Longer Meet the NESHI Criteria12 participants
Secondary

Number of Participants With a Clinical Global Impression - Improvement (CGI-I) Score ≤ 2

The CGI-I scale is a clinician rating of overall therapeutic effect ranging from 1 (very much improved) to 7 (very much worse) since commencing treatment.

Time frame: 12 weeks

ArmMeasureValue (NUMBER)
EscitalopramNumber of Participants With a Clinical Global Impression - Improvement (CGI-I) Score ≤ 212 participants
PlaceboNumber of Participants With a Clinical Global Impression - Improvement (CGI-I) Score ≤ 27 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026