Topiramate Augmentation in Bulimia Nervosa Partial Responders

This study is currently recruiting participants.

Verified by Neuropsychiatric Research Institute, Fargo, North Dakota, October 2009

First Received: October 1, 2009 No Changes Posted

Sponsor:	Neuropsychiatric Research Institute, Fargo, North Dakota
Information provided by:	Neuropsychiatric Research Institute, Fargo, North Dakota
ClinicalTrials.gov Identifier:	NCT00988481

Purpose

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.

Condition	Intervention	Phase
Bulimia Nervosa	Drug: Topiramate	Phase IV

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Topiramate Augmentation in Bulimia Nervosa Partial Responders

Resource links provided by NLM:

Drug Information available for: Topiramate

U.S. FDA Resources

Further study details as provided by Neuropsychiatric Research Institute, Fargo, North Dakota:

Primary Outcome Measures:

Weekly number of binge eating episodes and purging episodes [ Time Frame: Weekly for 10 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Abstinence from BN symptoms [ Time Frame: Baseline and endpoint (week 1 and week 10) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	10
Study Start Date:	September 2009
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female subjects meeting DSM-IV diagnostic criteria for 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988481

Contacts

Contact: James L Roerig, PharmD, BCPP	877-299-3511 ext 4919	jroerig@nrifargo.com
Contact: Joshua C Johnson, BA	877-299-3511 ext 4970	jjohnson@nrifargo.com

Locations

United States, North Dakota
Neuropsychiatric Research Institute	Recruiting
Fargo, North Dakota, United States, 58103
Principal Investigator: James L Roerig, PharmD, BCPP

Sponsors and Collaborators

Neuropsychiatric Research Institute, Fargo, North Dakota

Investigators

Principal Investigator:

James L Roerig, PharmD, BCPP

Neuropsychiatric Research Institute, University of North Dakota

More Information

Additional Information:

NRI Official Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Neuropsychiatric Research Institute ( James L. Roerig, PharmD, BCPP )
Study ID Numbers:	200909-046
Study First Received:	October 1, 2009
Last Updated:	October 1, 2009
ClinicalTrials.gov Identifier:	NCT00988481 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Neuropsychiatric Research Institute, Fargo, North Dakota:

Bulimia Nervosa
Topiramate
Augmentation

Additional relevant MeSH terms:

Signs and Symptoms, Digestive
Physiological Effects of Drugs
Protective Agents
Neuroprotective Agents
Pharmacologic Actions
Hyperphagia
Anti-Obesity Agents
Bulimia Nervosa

Signs and Symptoms
Mental Disorders
Therapeutic Uses
Bulimia
Topiramate
Central Nervous System Agents
Eating Disorders
Anticonvulsants

ClinicalTrials.gov processed this record on March 18, 2010