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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
  Purpose
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.

Condition Intervention
Night Eating Syndrome
Drug: Escitalopram
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 40
Study Start Date: October 2008
Study Completion Date: July 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Escitalopram
Drug: Escitalopram
10-20 mg
Placebo Comparator: B
Placebo
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636649

Locations
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
Sponsors and Collaborators
Duke University
St. Louis University
Investigators
Principal Investigator: Kishore Gadde, MD Duke University
  More Information

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00636649     History of Changes
Other Study ID Numbers: Pro00007133  LXP-MD-128A 
Study First Received: February 3, 2008
Results First Received: December 7, 2012
Last Updated: May 23, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
Eating disorder

Additional relevant MeSH terms:
Syndrome
Disease
Pathologic Processes
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on September 28, 2016