NCT01131572

Brief Summary

This study tests NAC in the treatment of 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_2

Timeline
Completed

Started Feb 2010

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2010

Completed
1.8 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

May 10, 2013

Status Verified

May 1, 2013

Enrollment Period

2.1 years

First QC Date

May 24, 2010

Last Update Submit

May 8, 2013

Conditions

NAC

Outcome Measures

Primary Outcomes (1)

  • Binge-purge episodes

    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.

    per week

Study Arms (1)

N-acetylcysteine

OTHER

open label treatment. Each subject receives N-acetylcysteine.

Drug: N-acetylcysteine NAC

Interventions

N-acetylcysteine NACDRUG

N-acetylcysteine in the treatment of Bulimia Nervosa

N-acetylcysteine

Eligibility Criteria

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

You may qualify if:

  • Bulimia Nervosa
  • years of age

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

Related Links

MeSH Terms

Interventions

Acetylcysteine

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2010

First Posted

May 27, 2010

Study Start

February 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

May 10, 2013

Record last verified: 2013-05

Locations

US(1)