Topiramate Augmentation in Bulimia Nervosa Partial Responders

Withdrawn before enrolling · Phase 4

Conditions studied: Bulimia Nervosa

In brief

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.

Key facts

Study ID

NCT00988481

Run by

Neuropsychiatric Research Institute, Fargo, North Dakota

People needed

0

Starts

2009-09-01

Expected to finish

2010-09-01

Last updated by the study team

2015-07-15

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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