Topiramate Augmentation in Bulimia Nervosa Partial Responders
| Status: | Withdrawn |
|---|---|
| Conditions: | Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 4/21/2016 |
| Start Date: | September 2009 |
| End Date: | September 2010 |
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.
(additional) medication to patients suffering from bulimia nervosa who have responded but
not had complete symptom resolution with a course of standard medication treatment.
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.
(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.
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.
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