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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

• Drug: olanzapine/topiramate
  • olanzapine - 5 mg/day to 20 mg/day, oral topiramate - 25 mg/day to 100 mg/day, oral
• Drug: olanzapine/placebo
  • olanzapine - 5 mg/day to 20 mg/day, oral placebo - oral

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• To examine the efficacy of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder.
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• To examine the tolerability of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder.
  • Time Frame: 12 weeks
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 10 Years

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Cincinnati

Overall Clinical Trial Officials and Contacts

Melissa P DelBello, MD Principal Investigator University of Cincinnati  

Overall Contact: Allison Albertz, BSN, RN 513-558-4812 allison.albertz@psychiatry.uc.edu

Information obtained from ClinicalTrials.gov on October 06, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00394095

Study ID Number: F1D-MC-X304

ClinicalTrials.gov Identifier: NCT00394095

Health Authority: United States: Food and Drug Administration