Escitalopram Treatment of Night Eating Syndrome

NCT ID: NCT00636649

Last Updated: 2016-06-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Night Eating Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Escitalopram

Group Type EXPERIMENTAL

Escitalopram

Intervention Type DRUG

10-20 mg

B

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Escitalopram

10-20 mg

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Louis University

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kishore Gadde, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Saint Louis University

St Louis, Missouri, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22544016 (View on PubMed)

Other Identifiers

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LXP-MD-128A

Identifier Type: -

Identifier Source: secondary_id

Pro00007133

Identifier Type: -

Identifier Source: org_study_id

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