Escitalopram Treatment of Night Eating Syndrome
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Escitalopram Treatment of Night Eating Syndrome: a Randomized Controlled Trial|
- Night Eating Questionnaire [ Time Frame: 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.
- Change in Beck Depression Inventory II (BDI-II) Score [ Time Frame: 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 Coping Inventory for Stressful Situations (CISS) [ Time Frame: 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 Perceived Stress Scale (PSS) [ Time Frame: 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.
- Change in Three Factor Eating Questionnaire (TFEQ) [ Time Frame: 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
- Number of Participants With a Clinical Global Impression - Improvement (CGI-I) Score ≤ 2 [ Time Frame: 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.
- Change in Lipid Panel [ Time Frame: Baseline,12 weeks ]
- Change in Beck Anxiety Inventory (BAI) Score [ Time Frame: 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 Glucose [ Time Frame: Baseline, 12 Week ]
- Change in Weight [ Time Frame: Baseline, 12 week ]
- Number of Participants Who no Longer Meet the NESHI Criteria [ Time Frame: 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.
- Number of Participants Who Had a 50% Reduction in NEQ Scores [ Time Frame: 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.
|Study Start Date:||October 2008|
|Study Completion Date:||July 2011|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Placebo Comparator: B
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636649
|United States, Missouri|
|Saint Louis University|
|St. Louis, Missouri, United States, 63103|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Kishore Gadde, MD||Duke University|