Pilot Study of Topiramate and Olanzapine in the Prevention of Weight Gain in Children and Adolescents With Bipolar Disorder
Information source: University of Cincinnati
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder; Weight Gain
Intervention: olanzapine/topiramate (Drug); olanzapine/placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Cincinnati Official(s) and/or principal investigator(s):
Melissa P DelBello, MD, Principal Investigator, Affiliation: University of Cincinnati
Overall contact:
Allison Albertz, BSN, RN, Phone: 513-558-4812, Email: allison.albertz@psychiatry.uc.edu
Summary
The primary objective of this study is to examine the efficacy of topiramate in combination
with olanzapine for the prevention of weight gain in youth with bipolar disorder. The
secondary objective is to examine the tolerability of topiramate in combination with
olanzapine for the prevention of weight gain in youth with bipolar disorder.
Clinical Details
Official title: A Double-Blind, Randomized, Placebo-Controlled, Pilot Study of Topiramate vs. Placebo in Combination With Olanzapine for the Prevention of Weight Gain in Manic or Mixed Youth With Bipolar Disorder
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment
Primary outcome: To examine the efficacy of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder.
Secondary outcome: To examine the tolerability of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder.
Eligibility
Minimum age: 10 Years.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Male or female patients, ages 10-18 years.
2. Female patients of menarche must be using a medically accepted means of contraception
(e. g. oral contraceptives, Depo-Provera, abstinence).
3. Each patient's authorized legal guardian must understand the nature of the study and
must provide written informed consent. Each patient must also give assent to study
participation.
4. Patients must have a diagnosis of Diagnostic and Statistical Manual of Mental
Disorders, Fourth Edition (DSM-IV-TR) bipolar disorder, type I and currently display
an acute manic or mixed episode as determined by K-SADS (Geller et al 2000).
5. Patients must have a baseline (day 0) Young Mania Rating Scale score of at least 16.
6. Subjects should be fluent in English.
Exclusion Criteria:
1. Female patients who are either pregnant or lactating.
2. Clinically significant or unstable hepatic, renal, gastroenterologic, respiratory,
cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical
conditions.
3. Any history of current or past diabetes that has been treated with pharmacological
intervention.
4. Neurological disorders including epilepsy, stroke, or severe head trauma.
5. Clinically significant laboratory abnormalities (> 3 times upper limit of normal), on
any of the following tests: CBC with differential, electrolytes, BUN, creatinine,
hepatic transaminases, lipid profile, fasting glucose, urinalysis, or thyroid indices.
Clinically abnormal ECG.
6. Manic or mixed episode due to a general medical condition or substance-induced mania
(DSM-IV-TR).
7. Mental retardation (IQ <70).
8. History of hypersensitivity to or intolerance of olanzapine or topiramate.
9. Prior history of olanzapine or topiramate non-response or allergic reaction.
10. DSM-IV substance (except nicotine or caffeine) dependence within the past 3 months.
11. Judged clinically to be at suicidal risk (defined as having active suicidal ideation,
intent or plan, or a serious suicide attempt within 30 days, or a baseline Children's
Depression Rating Scale suicide score of >3).
12. Treatment with an injectable depot neuroleptic within less than one dosing interval
between depot neuroleptic injections and day 0.
13. Treatment with concurrent mood stabilizers or anticonvulsants, benzodiazepines (except
as described below), psychostimulants, guanethidine, or guanadrel, or
antidepressants.
14. Schizophrenia or other psychotic disorders (including schizophreniform disorder,
schizoaffective disorder, delusional disorder, brief psychotic disorder, shared
psychotic disorder, psychotic disorder due to a general medical condition,
substance-induced psychotic disorder, psychotic disorder not otherwise specified) as
defined in the DSM-IV.
15. Major depressive disorder, dysthymic disorder, depressive disorder not otherwise
specified.
Locations and Contacts
Allison Albertz, BSN, RN, Phone: 513-558-4812, Email: allison.albertz@psychiatry.uc.edu
University of Cincinnati Medical Center, Cincinnati, Ohio 45267-0559, United States; Recruiting
Jenny Daniels, MA, Phone: 513-558-0956, Email: jennifer.daniels@psychiatry.uc.edu
Melissa P DelBello, MD, Principal Investigator
Additional Information
Starting date: December 2006
Ending date: December 2009
Last updated: July 21, 2008
|
