Topiramate Augmentation in Bulimia Nervosa Partial Responders

Study Overview
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Brief Summary
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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
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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.

Official Title
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Topiramate Augmentation in Bulimia Nervosa Partial Responders

Conditions
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Bulimia Nervosa

Intervention / Treatment
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* Drug: Topiramate


Participation Criteria
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Eligibility Criteria
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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 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Topiramate|Topiramate titrated to 200mg/day over four weeks, for ten weeks|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weekly number of binge eating episodes and purging episodes |  | Weekly for 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abstinence from BN symptoms |  | Baseline and endpoint (week 1 and week 10) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bulimia Nervosa, Topiramate, Augmentation