Escitalopram Treatment of Night Eating Syndrome

This study has been completed.
Sponsor:
Collaborator:
St. Louis University
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00636649
First received: February 3, 2008
Last updated: May 23, 2016
Last verified: May 2016

February 3, 2008
May 23, 2016
October 2008
August 2010   (final data collection date for primary outcome measure)
Night Eating Questionnaire [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
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.
Night Eating Syndrome Questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00636649 on ClinicalTrials.gov Archive Site
  • Change in Beck Depression Inventory II (BDI-II) Score [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change in Beck Anxiety Inventory (BAI) Score [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change in Weight [ Time Frame: Baseline, 12 week ] [ Designated as safety issue: No ]
  • Number of Participants Who no Longer Meet the NESHI Criteria [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • BDI II [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • CISS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • PSS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • TFEQ [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • CGI-I [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Lipids [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Escitalopram Treatment of Night Eating Syndrome
Escitalopram Treatment of Night Eating Syndrome: a Randomized Controlled Trial
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Night Eating Syndrome
  • Drug: Escitalopram
    10-20 mg
  • Drug: Placebo
    Placebo
  • Experimental: A
    Escitalopram
    Intervention: Drug: Escitalopram
  • Placebo Comparator: B
    Placebo
    Intervention: Drug: Placebo
Vander Wal JS, Gang CH, Griffing GT, Gadde KM. Escitalopram for treatment of night eating syndrome: a 12-week, randomized, placebo-controlled trial. J Clin Psychopharmacol. 2012 Jun;32(3):341-5. doi: 10.1097/JCP.0b013e318254239b.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2011
August 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00636649
Pro00007133, LXP-MD-128A
No
Not Provided
Not Provided
Duke University
Duke University
St. Louis University
Principal Investigator: Kishore Gadde, MD Duke University
Duke University
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP