Topiramate Augmentation in Bulimia Nervosa Partial Responders
This study has been withdrawn prior to enrollment.
(Difficulty with enrollment.)
First Posted: October 2, 2009
Last Update Posted: July 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
Information provided by (Responsible Party):
James Roerig, Neuropsychiatric Research Institute, Fargo, North Dakota
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.
||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
||Topiramate Augmentation in Bulimia Nervosa Partial Responders
Primary Outcome Measures:
- Weekly number of binge eating episodes and purging episodes [ Time Frame: Weekly for 10 weeks ]
Secondary Outcome Measures:
- Abstinence from BN symptoms [ Time Frame: Baseline and endpoint (week 1 and week 10) ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2010 (Final data collection date for primary outcome measure)
Topiramate titrated to 200mg/day over four weeks, for ten weeks
Other Name: Topamax
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.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:
||18 Years to 60 Years (Adult)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00988481
|Neuropsychiatric Research Institute (NRI)
|Fargo, North Dakota, United States, 58103 |
Neuropsychiatric Research Institute, Fargo, North Dakota
||James L Roerig, PharmD, BCPP
||Neuropsychiatric Research Institute, University of North Dakota
||James Roerig, Principal investigator, Neuropsychiatric Research Institute, Fargo, North Dakota
History of Changes
|Other Study ID Numbers:
||October 1, 2009
||October 2, 2009
|Last Update Posted:
||July 15, 2015
Keywords provided by James Roerig, Neuropsychiatric Research Institute, Fargo, North Dakota:
Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Physiological Effects of Drugs