N-acetylcysteine in the Treatment of Bulimia Nervosa

Bulimia Nervosa Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01033149
• Other study ID #: 19223, 09-09-18-01
• Secondary ID: NAC in Bulimia N
• Status: Terminated
• Phase: Phase 3
• First received: December 14, 2009
• Last updated: March 4, 2014
• Start date: December 2009
• Est. completion date: March 2012

Study information

• Verified date: March 2014
• Source: Lindner Center of HOPE
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The specific aim of this study is to evaluate the efficacy, tolerability, and safety of N-acetylcysteine (NAC) in the treatment on bulimia nervosa.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 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.

2. 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:

1. Eating, in a fixed period of time, an amount of food that is definitely larger than most people would eat under similar circumstances.

2. 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.

3. 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:

1. Have current body mass index (BMI) < 20kg/m2.

2. Women who are pregnant or lactating and women of childbearing potential who are not taking adequate contraceptive measures.

3. Subjects who are displaying clinically significant suicidality or homicidality.

4. A current or recent (within 6 months of the start of NAC) DSM-IV-TR diagnosis of substance abuse or dependence.

5. History of a personality disorder (eg, schizotypal, borderline, or antisocial) which might interfere with assessment or compliance with study procedures

6. 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.

7. DSM-IV-TR Anorexia nervosa

8. Serum potassium of = 0.3mmol/L

9. Myocardial infarction within six months

10. Subjects taking more than 200 /µg of selenium per day, or 500 IU of Vitamin E /day

11. Subjects with known or suspected clinically relevant systemic medical disorder, including asthma, bronchospasm, or respiratory insufficiency.

12. Subjects who had recently used medications (<14 days) felt to be hazardous if taken with NAC (e.g. carbamazepine, nitroglycerin).

13. 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 Design

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

Related Conditions & MeSH terms

• Bulimia
• Bulimia Nervosa

Intervention

Drug:
• N-acetylcysteine
N-acetylcysteine, flexible dose 1200-2400mg/day

Locations

Country	Name	City	State
United States	Lindner Center of HOPE	Mason	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Lindner Center of HOPE	University of Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (1)

Guerdjikova AI, Blom TJ, Mori N, McElroy SL. N-acetylcysteine in bulimia nervosa--open-label trial. Eat Behav. 2013 Jan;14(1):87-9. doi: 10.1016/j.eatbeh.2012.11.001. Epub 2012 Nov 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure will be the weekly frequency of binge-purge episodes.		12 weeks	No