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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: March 25, 2013
Last verified: February 2013
History of Changes

February 3, 2008
March 25, 2013
October 2008
August 2010   (final data collection date for primary outcome measure)
Night Eating Syndrome Questionnaire [ Time Frame: 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
  • 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 ]
Same as current
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. PubMed PMID: 22544016.

*   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
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00636649
Pro00007133 (LXP-MD-128A), LXP-MD-128A
No
Duke University
Duke University
St. Louis University
Principal Investigator: Kishore Gadde, MD Duke University
Duke University
February 2013

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