Bulimia NervosaPhase 4NCT00988481
Topiramate Augmentation in Bulimia Nervosa Partial Responders
A Phase 4 study testing Topiramate in people with Bulimia Nervosa, run by Neuropsychiatric Research Institute, Fargo, North Dakota at 1 site in United States.
Trial summary
The goal of this study is to generate pilot data exploring the addition of an augmentation (additional) medication to patients suffering from bulimia nervosa who have responded but not had complete symptom resolution with a course of standard medication treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bulimia Nervosa
- What is being tested?
- Topiramate
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2010
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subjects meeting Diagnostic and Statistical Manual IV edition (DSM-IV) diagnostic criteria for bulimia nervosa (BN).
- Subjects must be between the ages of 18 and 60 years.
- Subjects must currently demonstrate partial response to a standard BN pharmacotherapy treatment.
- Women of child-bearing potential must be practicing an accepted method of birth control (barrier method or oral contraceptive) and have a negative pregnancy test at baseline.
- Subjects must be of good general health by history, laboratory assessment and physical exam.
- Subject's BMI must be >20 and <27 kg/m^2.
Who cannot join
- Subjects who are allergic to topiramate.
- Subjects who meet DSM-IV criteria for anorexia nervosa.
- Women who are pregnant or nursing at the time of study.
- Subjects experiencing clinically significant, unstable neurological, cardiac, hepatic or renal disease or narrow angle glaucoma.
- Subjects with a history of nephrolithiasis.
- Subjects with a serum potassium <3.0 mmol/L
Show all 13Show fewer
- Subjects cannot start psychotherapy during the study.
- Subjects currently or with a past history of meeting DSM-IV diagnostic criteria for schizophrenia, schizoaffective disorder, or bipolar disorder.
- Subjects receiving antipsychotic agents, mood stabilizers, antianxiety agents or other non-antidepressant psychotropic agent currently.
- Subjects currently or with a history within the past year of meeting DSM-IV diagnostic criteria for substance abuse.
- Subjects who are experiencing clinically significant suicidal ideation (subjects will be referred to appropriate caregiver).
- Subjects who have participated in an investigational drug study in the past 30 days.
- Subjects who are receiving any prescription medications other than oral contraceptives that will interact with any of the study medication.
Trial locations and contacts
1 site in 1 country.
United States1 site
Neuropsychiatric Research Institute (NRI)
Fargo, North Dakota, 58103
About this study
The goal of this study is to generate pilot data exploring the addition of an augmentation (additional) medication to patients suffering from bulimia nervosa who have responded but not had complete symptom resolution with a course of standard medication treatment.
Read the detailed description
The aim of this study is to determine whether the addition of an augmentation medication (topiramate 200mg/d) will confer additional reductions in symptomatology in BN patients who have received six weeks of standard pharmacological treatment with fluoxetine 60 mg/day or its equivalent and had a partial response but are not in symptomatic remission.
- Conditions
- Bulimia Nervosa
- Being tested
- Topiramate
- Keywords
- Bulimia Nervosa, Topiramate, Augmentation
- Medical subject headings
- Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopiramateDrug
Also called Topamax
Topiramate titrated to 200mg/day over four weeks, for ten weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly number of binge eating episodes and purging episodes
Measured: Weekly for 10 weeks
Secondary outcomes (1)
Abstinence from BN symptoms
Measured: Baseline and endpoint (week 1 and week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2010 (estimated)
- Study completionSep 2010 (estimated)
Why it stopped: Difficulty with enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuropsychiatric Research Institute, Fargo, North Dakota
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Roerig, Neuropsychiatric Research Institute, Fargo, North Dakota
- Investigators
- James L Roerig, PharmD, BCPP, Principal investigator, Neuropsychiatric Research Institute, University of North Dakota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988481
- Sponsor's protocol ID
- 200909-046
- Status last verified
- Jul 2015
- First submitted
- 1 Oct 2009
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topiramate Augmentation in Bulimia Nervosa Partial Responders
- ClinicalTrials.gov ID
- NCT00988481
- Acronym / sponsor ID
- 200909-046
- Conditions
- Bulimia Nervosa
- Keywords
- Bulimia Nervosa, Topiramate, Augmentation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty with enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Neuropsychiatric Research Institute, Fargo, North DakotaUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 2 Oct 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 goal of this study is to generate pilot data exploring the addition of an augmentation (additional) medication to patients suffering from bulimia nervosa who have responded but not had complete symptom resolution with a course of standard medication treatment.
Detailed description
The aim of this study is to determine whether the addition of an augmentation medication (topiramate 200mg/d) will confer additional reductions in symptomatology in BN patients who have received six weeks of standard pharmacological treatment with fluoxetine 60 mg/day or its equivalent and had a partial response but are not in symptomatic remission.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female subjects meeting Diagnostic and Statistical Manual IV edition (DSM-IV) diagnostic criteria for bulimia nervosa (BN).
- Subjects must be between the ages of 18 and 60 years.
- Subjects must currently demonstrate partial response to a standard BN pharmacotherapy treatment.
- Women of child-bearing potential must be practicing an accepted method of birth control (barrier method or oral contraceptive) and have a negative pregnancy test at baseline.
- Subjects must be of good general health by history, laboratory assessment and physical exam.
Key exclusion criteria (13 listed)
- Subjects who are allergic to topiramate.
- Subjects who meet DSM-IV criteria for anorexia nervosa.
- Women who are pregnant or nursing at the time of study.
- Subjects experiencing clinically significant, unstable neurological, cardiac, hepatic or renal disease or narrow angle glaucoma.
- Subjects with a history of nephrolithiasis.
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 |
|---|---|---|
| TopiramateAlso: TopamaxTopiramate titrated to 200mg/day over four weeks, for ten weeks | Drug | – |
Primary outcome
Weekly number of binge eating episodes and purging episodes
Time frame: Weekly for 10 weeks
1 secondary outcome
Abstinence from BN symptoms
Time frame: Baseline and endpoint (week 1 and week 10)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
Related trials for Bulimia Nervosa
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
Understanding and Targeting Self-Regulatory Control in Bulimia Nervosa
Bulimia Nervosa, Feeding and Eating Disorders
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Recruiting
Neurofeedback During Eating for Bulimia Nervosa
Bulimia Nervosa
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.
James L Roerig, PharmD, BCPP principal investigator
Neuropsychiatric Research Institute, University of North Dakota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topiramate in people with Bulimia Nervosa, run by Neuropsychiatric Research Institute, Fargo, North Dakota 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 6 inclusion and 13 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: withdrawn, as of the sponsor's last update on 15 Jul 2015. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 withdrawn before enrolling participants, so there are no results.
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?
Weekly number of binge eating episodes and purging episodes (time frame: Weekly for 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2015.