Topiramate Augmentation in Bulimia Nervosa Partial Responders

NCT00988481 | Withdrawn Phase 4

• 1 other identifier: 200909-046
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Bulimia Nervosa

Keywords

Bulimia Nervosa; Topiramate; Augmentation

Outcome Measures

Primary Outcomes (1)

• Weekly number of binge eating episodes and purging episodes

  Weekly for 10 weeks

Secondary Outcomes (1)

• Abstinence from BN symptoms

  Baseline and endpoint (week 1 and week 10)

Interventions

Topiramate DRUG

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

Also known as: Topamax

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neuropsychiatric Research Institute, Fargo, North Dakota: lead

Study Sites (1)

Neuropsychiatric Research Institute (NRI)

Fargo, North Dakota, 58103, United States

Location

Related Links

• NRI Official Website

MeSH Terms

Conditions

Bulimia Nervosa

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• James L Roerig, PharmD, BCPP

  Neuropsychiatric Research Institute, University of North Dakota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 1, 2009
• First Posted: October 2, 2009
• Study Start: September 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 15, 2015

Record last verified: 2015-07

Locations

US (1)