A Double Blind Clinical Trial of DCS for Food Anxiety

NCT ID: NCT01996644

Last Updated: 2018-03-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-02-28

Brief Summary

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This is a pilot study investigating if cycloserine (DCS; a learning enhancement medication) augments exposure therapy for food anxiety in patients with anorexia and bulimia nervosa. The investigators expect that (a) exposure therapy will reduce anxiety (b) anxiety will be reduced more in the DCS relative to placebo condition (c) participants in the DCS condition will have a greater increase in Body Mass Index.

Detailed Description

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This study investigated if DCS vs placebo augmented food exposure in individuals with eating disorders.

Conditions

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Anorexia and Bulimia Nervosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Setraline

250 mg DCS (setraline) versus placebo plus exposure

Group Type EXPERIMENTAL

Setraline

Intervention Type DRUG

250mg DCS

placebo

Placebo group plus exposure

Group Type PLACEBO_COMPARATOR

Placebo vs Setraline

Intervention Type DRUG

Placebo

Interventions

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Placebo vs Setraline

Placebo

Intervention Type DRUG

Setraline

250mg DCS

Intervention Type DRUG

Other Intervention Names

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Placebo

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with Anorexia Nervosa, Bulimia Nervosa, Eating Disorder Not Otherwise Specified

Exclusion Criteria

* Pregnant or planning on becoming pregnant
* Psychotic or Manic
Minimum Eligible Age

14 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Washington University

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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Levinson CA, Rodebaugh TL, Fewell L, Kass AE, Riley EN, Stark L, McCallum K, Lenze EJ. D-Cycloserine facilitation of exposure therapy improves weight regain in patients with anorexia nervosa: a pilot randomized controlled trial. J Clin Psychiatry. 2015 Jun;76(6):e787-93. doi: 10.4088/JCP.14m09299.

Reference Type DERIVED
PMID: 26132687 (View on PubMed)

Other Identifiers

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F31MH096433-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201212062

Identifier Type: -

Identifier Source: org_study_id

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