Topiramate Augmentation in Bulimia Nervosa Partial Responders

Neuropsychiatric Research Institute, Fargo, North Dakota1 site in 1 countrySeptember 2009

ConditionsBulimia Nervosa

DrugsTopiramate

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Bulimia Nervosa
Sponsor: Neuropsychiatric Research Institute, Fargo, North Dakota
Locations: 1
Primary Endpoint: Weekly number of binge eating episodes and purging episodes
Status: Withdrawn
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

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.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

September 2010

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Neuropsychiatric Research Institute, Fargo, North Dakota

Responsible Party

Principal Investigator

James Roerig

Principal investigator

Neuropsychiatric Research Institute, Fargo, North Dakota

Eligibility Criteria

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.