Bulimia NervosaPhase 3NCT01033149
N-acetylcysteine in the Treatment of Bulimia Nervosa
A Phase 3 study testing N-acetylcysteine in people with Bulimia Nervosa, run by Lindner Center of HOPE at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bulimia Nervosa
- What is being tested?
- N-acetylcysteine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Mar 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The specific aim of this study is to evaluate the efficacy, tolerability, and safety of N-acetylcysteine (NAC) in the treatment on bulimia nervosa.
- Conditions
- Bulimia Nervosa
- Being tested
- N-acetylcysteine
- Medical subject headings
- Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
N-acetylcysteine, flexible dose 1200-2400mg/day
| Study group | Role | What they receive |
|---|---|---|
| N-acetylcysteine | Other | open label N-acetylcysteine, flexible dose Receives: Drug: N-acetylcysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will be the weekly frequency of binge-purge episodes.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bulimia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindner Center of HOPE
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cincinnati
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033149
- Sponsor's protocol ID
- 19223, 09-09-18-01
- Other IDs
- NAC in Bulimia Nervosa
- Status last verified
- Mar 2014
- First submitted
- 14 Dec 2009
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23265409
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-acetylcysteine in the Treatment of Bulimia Nervosa
- ClinicalTrials.gov ID
- NCT01033149
- Acronym / sponsor ID
- 19223, 09-09-18-01
- Conditions
- Bulimia Nervosa
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Lindner Center of HOPEUniversity, hospital or other
- Collaborators
- University of Cincinnati
- Study start
- Dec 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 16 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The specific aim of this study is to evaluate the efficacy, tolerability, and safety of N-acetylcysteine (NAC) in the treatment on bulimia nervosa.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| N-acetylcysteine | Other | Drug: N-acetylcysteineopen label N-acetylcysteine, flexible dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Capacity to consent to the study and comply with study procedures.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetylcysteineN-acetylcysteine, flexible dose 1200-2400mg/day | Drug | N-acetylcysteine |
Primary outcome
The primary outcome measure will be the weekly frequency of binge-purge episodes.
Time frame: 12 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2014.
- Results publication: PubMed 23265409Guerdjikova 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing N-acetylcysteine in people with Bulimia Nervosa, run by Lindner Center of HOPE at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure will be the weekly frequency of binge-purge episodes. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01033149, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2014.