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Topiramate Augmentation in Bulimia Nervosa Partial Responders

Information source: Neuropsychiatric Research Institute, Fargo, North Dakota
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bulimia Nervosa

Intervention: Topiramate (Drug)

Phase: Phase 4

Status: Withdrawn

Sponsored by: Neuropsychiatric Research Institute, Fargo, North Dakota

Official(s) and/or principal investigator(s):
James L Roerig, PharmD, BCPP, Principal Investigator, Affiliation: Neuropsychiatric Research Institute, University of North Dakota


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.

Clinical Details

Official title: Topiramate Augmentation in Bulimia Nervosa Partial Responders

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

Primary outcome: Weekly number of binge eating episodes and purging episodes

Secondary outcome: Abstinence from BN symptoms

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.


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.


Inclusion Criteria:

- 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


- 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.

Exclusion Criteria:

- 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

- 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.

Locations and Contacts

Neuropsychiatric Research Institute (NRI), Fargo, North Dakota 58103, United States
Additional Information

NRI Official Website

Starting date: September 2009
Last updated: July 13, 2015

Page last updated: August 23, 2015

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