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: July 9, 2014
Last verified: February 2013
  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 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.


Secondary Outcome Measures:
  • 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 ]

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
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: July 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
Eating disorder

Additional relevant MeSH terms:
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on July 24, 2014