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N-acetylcysteine in Bulimia Nervosa

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Lindner Center of HOPE
ClinicalTrials.gov Identifier:
NCT01131572
First received: May 24, 2010
Last updated: May 8, 2013
Last verified: May 2013
History of Changes
  Purpose

This study tests NAC in the treatment of Bulimia Nervosa.


Condition Intervention Phase
NAC
 Drug: N-acetylcysteine NAC
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lindner Center of HOPE:

Primary Outcome Measures:
  • Binge-purge episodes [ Time Frame: per week ] [ Designated as safety issue: No ]
    The primary outcome measure will be the weekly frequency of binge-purge episodes. A binge-purge eating episode will be defined using DSM-IV-TR criteria, and accessed via clinical interview and review of subject take-home diaries at each study visit.


Enrollment: 11
Study Start Date: February 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
N-acetylcysteine
open label treatment. Each subject receives N-acetylcysteine.
 Drug: N-acetylcysteine NAC
N-acetylcysteine in the treatment of Bulimia Nervosa

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Bulimia Nervosa
  • 18-65 years of age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01131572

Locations
United States, Ohio
Lindner Center of HOPE
Mason, Ohio, United States, 45040
Sponsors and Collaborators
Lindner Center of HOPE
  More Information

Additional Information:
Lindner Center of HOPE research page  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Lindner Center of HOPE
ClinicalTrials.gov Identifier: NCT01131572     History of Changes
Other Study ID Numbers: IRB19223, 09-09-18-01
Study First Received: May 24, 2010
Last Updated: May 8, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bulimia Nervosa
Eating Disorders
Mental Disorders
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on May 16, 2013