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Topiramate Augmentation in Bulimia Nervosa Partial Responders

Primary Purpose

Bulimia Nervosa

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Topiramate

About this trial

This is an interventional treatment trial for Bulimia Nervosa focused on measuring Bulimia Nervosa, Topiramate, Augmentation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Neuropsychiatric Research Institute (NRI)

Outcomes

Primary Outcome Measures

Weekly number of binge eating episodes and purging episodes

Secondary Outcome Measures

Abstinence from BN symptoms

Full Information

NCT ID

NCT00988481

First Posted

October 1, 2009

Last Updated

July 13, 2015

Sponsor

Neuropsychiatric Research Institute, Fargo, North Dakota

1. Study Identification

Unique Protocol Identification Number

NCT00988481

Brief Title

Topiramate Augmentation in Bulimia Nervosa Partial Responders

Official Title

Topiramate Augmentation in Bulimia Nervosa Partial Responders

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Difficulty with enrollment.

Study Start Date

September 2009 (undefined)

Primary Completion Date

August 2010 (Anticipated)

Study Completion Date

September 2010 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Neuropsychiatric Research Institute, Fargo, North Dakota

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bulimia Nervosa

Keywords

Bulimia Nervosa, Topiramate, Augmentation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Topiramate

Other Intervention Name(s)

Topamax

Intervention Description

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

Primary Outcome Measure Information:

Title

Weekly number of binge eating episodes and purging episodes

Time Frame

Weekly for 10 weeks

Secondary Outcome Measure Information:

Title

Abstinence from BN symptoms

Time Frame

Baseline and endpoint (week 1 and week 10)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James L Roerig, PharmD, BCPP

Organizational Affiliation

Neuropsychiatric Research Institute, University of North Dakota

Official's Role

Principal Investigator

Facility Information:

Facility Name

Neuropsychiatric Research Institute (NRI)

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58103

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.nrifargo.com/

Description

NRI Official Website

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Topiramate Augmentation in Bulimia Nervosa Partial Responders

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