Topiramate Augmentation in Bulimia Nervosa Partial Responders

July 13, 2015 updated by: James Roerig, Neuropsychiatric Research Institute, Fargo, North Dakota
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / 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.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Neuropsychiatric Research Institute (NRI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weekly number of binge eating episodes and purging episodes
Time Frame: Weekly for 10 weeks
Weekly for 10 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuropsychiatric Research Institute, Fargo, North Dakota

Investigators

  • Principal Investigator: James L Roerig, PharmD, BCPP, Neuropsychiatric Research Institute, University of North Dakota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

August 1, 2010

Study Completion (Anticipated)

September 1, 2010

Study Registration Dates

First Submitted

October 1, 2009

First Submitted That Met QC Criteria

October 1, 2009

First Posted (Estimate)

October 2, 2009

Study Record Updates

Last Update Posted (Estimate)

July 15, 2015

Last Update Submitted That Met QC Criteria

July 13, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200909-046

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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