Topiramate Augmentation in Bulimia Nervosa Partial Responders

NCT ID: NCT00988481

Last Updated: 2015-07-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2010-09-30

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.

Conditions

Bulimia Nervosa

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Topiramate

Topiramate titrated to 200mg/day over four weeks, for ten weeks

Intervention Type: DRUG

Other Intervention Names

Topamax

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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neuropsychiatric Research Institute, Fargo, North Dakota

OTHER

Sponsor Role: lead

Responsible Party

James Roerig

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James L Roerig, PharmD, BCPP

Role: PRINCIPAL_INVESTIGATOR

Neuropsychiatric Research Institute, University of North Dakota

Locations

Neuropsychiatric Research Institute (NRI)

Fargo, North Dakota, United States

Countries

United States

Related Links

http://www.nrifargo.com/

NRI Official Website

Other Identifiers

200909-046

Identifier Type: -

Identifier Source: org_study_id