- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01033149
N-acetylcysteine in the Treatment of Bulimia Nervosa
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Ohio
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Mason, Ohio, United States, 45040
- Lindner Center of Hope
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men or women, between the ages of 18 and 65. The patient population is expected to be predominantly made up of women based on previous research.
Patients will meet DSM-IV-TR criteria for BN for at least the last 6 months. These criteria are as follows:
A. Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following:
- Eating, in a fixed period of time, an amount of food that is definitely larger than most people would eat under similar circumstances.
- A sense of lack of control over eating during the episode B. Recurrent inappropriate compensatory behavior to prevent weight gain, such as: self-induced vomiting; misuse of laxatives; diuretics; or other medications; fasting; excessive exercise.
C. Binge-purge episodes occur at least two times a week in the last 3 months D. Self- evaluation in unduly influenced by body shape and weight E. The disturbance does not occur exclusively during episodes of anorexia nervosa.
- Capacity to consent to the study and comply with study procedures.
Exclusion Criteria:
Criteria for exclusion from this study will be any of the following:
- Have current body mass index (BMI) < 20kg/m2.
- Women who are pregnant or lactating and women of childbearing potential who are not taking adequate contraceptive measures.
- Subjects who are displaying clinically significant suicidality or homicidality.
- A current or recent (within 6 months of the start of NAC) DSM-IV-TR diagnosis of substance abuse or dependence.
- History of a personality disorder (eg, schizotypal, borderline, or antisocial) which might interfere with assessment or compliance with study procedures
- Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease which could interfere with diagnosis, assessment, or treatment of BN. Patients should be biochemically euthyroid prior to entering the study.
- DSM-IV-TR Anorexia nervosa
- Serum potassium of ≤ 0.3mmol/L
- Myocardial infarction within six months
- Subjects taking more than 200 /µg of selenium per day, or 500 IU of Vitamin E /day
- Subjects with known or suspected clinically relevant systemic medical disorder, including asthma, bronchospasm, or respiratory insufficiency.
- Subjects who had recently used medications (<14 days) felt to be hazardous if taken with NAC (e.g. carbamazepine, nitroglycerin).
- Subjects previously enrolled in this study; subjects who have previously been treated with NAC; subjects who have received an experimental drug or have used an experimental device within 30 days.
Subjects who are taking psychotropic medications will be allowed into the study as long as the dose of medication had been stable for 3 months before study inclusion and there are no plans to modify the dose during the study duration. Similarly, subjects evolved in psychotherapy for BN will be allowed to participate if attendance had been ongoing for at least 3 months before study entry. Subjects who changed doses of medication or started new therapy will be discontinued from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: N-acetylcysteine
open label N-acetylcysteine, flexible dose
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N-acetylcysteine, flexible dose 1200-2400mg/day
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary outcome measure will be the weekly frequency of binge-purge episodes.
Time Frame: 12 weeks
|
12 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Signs and Symptoms, Digestive
- Feeding and Eating Disorders
- Hyperphagia
- Bulimia
- Bulimia Nervosa
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Protective Agents
- Respiratory System Agents
- Antioxidants
- Antidotes
- Free Radical Scavengers
- Expectorants
- Acetylcysteine
- N-monoacetylcystine
Other Study ID Numbers
- 19223, 09-09-18-01
- NAC in Bulimia Nervosa
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bulimia Nervosa
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University of California, San DiegoRecruitingAnorexia Nervosa | Bulimia Nervosa | Atypical Anorexia Nervosa | Atypical Bulimia NervosaUnited States
-
Linnaeus UniversityGöteborg University; Linkoeping UniversityRecruitingBulimia Nervosa | Major Depression | Anorexia Nervosa/BulimiaSweden
-
Yeshiva UniversityYale UniversityRecruitingAnorexia Nervosa | Bulimia Nervosa | Anorexia Nervosa, Atypical | Bulimia; AtypicalUnited States
-
University Hospital, ToulouseUnknownAnorexia Nervosa/BulimiaFrance
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Maastricht UniversityZonMw: The Netherlands Organisation for Health Research and Development; Utrecht... and other collaboratorsRecruitingAnorexia Nervosa | Bulimia Nervosa | Atypical Anorexia Nervosa (Other Specified Eating Disorder) | Atypical Bulimia Nervosa (Other Specified Eating Disorder)Netherlands
-
Washington University School of MedicineNational Institute of Mental Health (NIMH)Completed
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Rosemary Claire RodenChildren's Miracle NetworkEnrolling by invitationBulimia Nervosa | Impulsive Behavior | Purging (Eating Disorders) | Eating Disorders | Eating Disorders in Adolescence | Anorexia Nervosa/Bulimia | Anorexia in Adolescence | Anorexia Nervosa, Atypical | Anorexia Nervosa, Binge Eating/Purging TypeUnited States
-
University Health Network, TorontoKlarman Family FoundationCompletedAnorexia Nervosa | Bulimia Nervosa
-
Drexel UniversityNational Institute of Mental Health (NIMH)Active, not recruitingBinge-Eating Disorder | Bulimia Nervosa | Binge Eating | Bulimia; Atypical | Binge-Eating and Purging Type Anorexia NervosaUnited States
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University Health Network, TorontoTerminatedAnorexia Nervosa | Bulimia NervosaCanada
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University of Sao Paulo General HospitalActive, not recruiting
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Indiana UniversityBioAdvantex PharmaCompletedHIV | Endothelial Dysfunction | Oxidative StressUnited States
-
Assaf-Harofeh Medical CenterUnknownChronic Kidney Diseases | General AnesthesiaIsrael
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Assistance Publique - Hôpitaux de ParisTerminatedSelenoprotein N-related MyopathyFrance
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VA Office of Research and DevelopmentNational Center for Complementary and Integrative Health (NCCIH)CompletedDiabetic Nephropathy | Proteinuria | Oxidative StressUnited States
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University of ChicagoNational Institute on Drug Abuse (NIDA); University of MinnesotaCompletedTobacco Use Disorder | GamblingUnited States
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Universidade Estadual de LondrinaUnknownInflammation | Tobacco Smoking | Oxidative StressBrazil