NCT01033149

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 16, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

March 5, 2014

Status Verified

March 1, 2014

Enrollment Period

2.2 years

First QC Date

December 14, 2009

Last Update Submit

March 4, 2014

Conditions

Bulimia Nervosa

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure will be the weekly frequency of binge-purge episodes.

    12 weeks

Study Arms (1)

N-acetylcysteine

OTHER

open label N-acetylcysteine, flexible dose

Drug: N-acetylcysteine

Interventions

N-acetylcysteineDRUG

N-acetylcysteine, flexible dose 1200-2400mg/day

N-acetylcysteine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lindner Center of HOPE

Mason, Ohio, 45040, United States

Location

Related 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.

    PMID: 23265409RESULT

MeSH Terms

Conditions

Bulimia Nervosa

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2009

First Posted

December 16, 2009

Study Start

December 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

March 5, 2014

Record last verified: 2014-03

Locations

US(1)