NCT00636649

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 14, 2008

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

May 6, 2013

Completed
Last Updated

June 29, 2016

Status Verified

May 1, 2016

Enrollment Period

1.8 years

First QC Date

February 3, 2008

Results QC Date

December 7, 2012

Last Update Submit

May 23, 2016

Conditions

Night Eating Syndrome

Keywords

Eating disorder

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (11)

  • Change in Beck Depression Inventory II (BDI-II) Score

    Baseline, 12 weeks

  • Change in Coping Inventory for Stressful Situations (CISS)

    Baseline, 12 weeks

  • Change in Perceived Stress Scale (PSS)

    12 weeks

  • Change in Three Factor Eating Questionnaire (TFEQ)

    Baseline, 12 weeks

  • Number of Participants With a Clinical Global Impression - Improvement (CGI-I) Score ≤ 2

    12 weeks

  • +6 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

Escitalopram

Drug: Escitalopram

B

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

EscitalopramDRUG

10-20 mg

A
PlaceboDRUG

Placebo

B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70 years
  • Presence of NES
  • BMI 25-50

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Saint Louis University

St Louis, Missouri, 63103, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related 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.

    PMID: 22544016BACKGROUND

MeSH Terms

Conditions

Night Eating SyndromeFeeding and Eating Disorders

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Kishore Gadde
Organization
Duke University Medical Center
kishore.gadde@duke.edu
919-668-0208

Study Officials

  • Kishore Gadde, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2008

First Posted

March 14, 2008

Study Start

October 1, 2008

Primary Completion

August 1, 2010

Study Completion

July 1, 2011

Last Updated

June 29, 2016

Results First Posted

May 6, 2013

Record last verified: 2016-05

Locations

US(2)