Escitalopram Treatment of Night Eating Syndrome

Not Applicable

Completed

• Conditions: Night Eating Syndrome
• Interventions: Drug: Placebo; Drug: Escitalopram

• Registration Number: NCT00636649
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-03
• Study First Submitted QC: 2008-03-13
• Study First Posted: 2008-03-14
• Study Start: 2008-10
• Primary Completion: 2010-08
• Study Completion: 2011-07
• Results First Submitted: 2012-12-07
• Results First Submitted QC: 2013-03-25
• Results First Posted: 2013-05-06
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-23
• Last Update Posted: 2016-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Placebo	Placebo
A	Escitalopram	Escitalopram

Primary Outcome Measures

Name	Time	Method
Night Eating Questionnaire	baseline, 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in Glucose	Baseline, 12 Week
Change in Three Factor Eating Questionnaire (TFEQ)	Baseline, 12 weeks	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
Change in Beck Depression Inventory II (BDI-II) Score	Baseline, 12 weeks	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.
Change in Lipid Panel	Baseline,12 weeks
Change in Weight	Baseline, 12 week
Number of Participants Who Had a 50% Reduction in NEQ Scores	Week 12	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.
Change in Coping Inventory for Stressful Situations (CISS)	Baseline, 12 weeks	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.
Change in Beck Anxiety Inventory (BAI) Score	Baseline, 12 weeks	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.
Change in Perceived Stress Scale (PSS)	12 weeks	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.
Number of Participants With a Clinical Global Impression - Improvement (CGI-I) Score ≤ 2	12 weeks	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.
Number of Participants Who no Longer Meet the NESHI Criteria	Week 12	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.

Trial Locations

Locations (2)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Saint Louis University; 🇺🇸 St. Louis, Missouri, United States