Topiramate Augmentation in Bulimia Nervosa Partial Responders

Bulimia Nervosa Clinical Trial

Official title:

Topiramate Augmentation in Bulimia Nervosa Partial Responders

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00988481
• Other study ID #: 200909-046
• Status: Withdrawn
• Phase: Phase 4
• First received: October 1, 2009
• Last updated: July 13, 2015
• Start date: September 2009
• Est. completion date: September 2010

Study information

• Verified date: July 2015
• Source: Neuropsychiatric Research Institute, Fargo, North Dakota
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bulimia
• Bulimia Nervosa

Intervention

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

Locations

Country	Name	City	State
United States	Neuropsychiatric Research Institute (NRI)	Fargo	North Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Neuropsychiatric Research Institute, Fargo, North Dakota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weekly number of binge eating episodes and purging episodes		Weekly for 10 weeks	Yes
Secondary	Abstinence from BN symptoms		Baseline and endpoint (week 1 and week 10)	Yes

External Links

•   NRI Official Website