Status:
WITHDRAWN
Topiramate Augmentation in Bulimia Nervosa Partial Responders
Lead Sponsor:
Neuropsychiatric Research Institute, Fargo, North Dakota
Conditions:
Bulimia Nervosa
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
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 sy...
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 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00988481
Start Date
September 1 2009
End Date
September 1 2010
Last Update
July 15 2015
Active Locations (1)
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1
Neuropsychiatric Research Institute (NRI)
Fargo, North Dakota, United States, 58103