Escitalopram Treatment of Night Eating Syndrome

Night Eating Syndrome Clinical Trial

Official title:

Escitalopram Treatment of Night Eating Syndrome: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00636649
• Other study ID #: Pro00007133
• Secondary ID: LXP-MD-128A
• Status: Completed
• Phase: N/A
• First received: February 3, 2008
• Last updated: February 11, 2016
• Start date: October 2008
• Est. completion date: July 2011

Study information

• Verified date: February 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Night Eating Syndrome
• Syndrome

Intervention

Drug:
• Escitalopram
10-20 mg
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	Saint Louis University	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	St. Louis University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Night Eating Questionnaire	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.	baseline, 12 weeks	No
Secondary	Beck Depression Inventory II (BDI-II)	The BDI-II is a 21-item self-report questionnaire designed to measure cognitive, somatic, and behavioral aspeets of depression. Scores range from 0 to 63, with higher scores indicating a higher level of depressive symptoms.	Baseline, 12 weeks	No
Secondary	Coping Inventory for Stressful Situations (CISS)		12 weeks	No
Secondary	Perceived Stress Scale (PSS)		12 weeks	No
Secondary	Three Factor Eating Questionnaire (TFEQ)		12 weeks	No
Secondary	Number of Participants With a Clinical Global Impression - Improvement (CGI-I) Score = 2	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.	12 weeks	No
Secondary	Change in Lipid Panel		Baseline,12 weeks	No
Secondary	Beck Anxiety Inventory (BAI)	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.	Baseline, 12 weeks	No
Secondary	Change in Glucose		Baseline, 12 Week	No
Secondary	Change in Weight		Baseline, 12 week	No
Secondary	Number of Participants Who no Longer Meet the NESHI Criteria	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.	Week 12	No
Secondary	Number of Participants Who Had a 50% Reduction in NEQ Scores	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.	Week 12	No