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Pilot Study of Topiramate and Olanzapine in the Prevention of Weight Gain in Children and Adolescents With Bipolar Disorder
This study is currently recruiting participants.
Verified by University of Cincinnati, July 2008
Sponsored by: University of Cincinnati
Information provided by: University of Cincinnati
ClinicalTrials.gov Identifier: NCT00394095
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Weight Gain
Drug: olanzapine/topiramate
Drug: olanzapine/placebo
Phase IV

MedlinePlus related topics: Bipolar Disorder
Drug Information available for: Topiramate Olanzapine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment
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

Further study details as provided by University of Cincinnati:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: December 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: olanzapine/topiramate
olanzapine - 5 mg/day to 20 mg/day, oral topiramate - 25 mg/day to 100 mg/day, oral
2: Placebo Comparator Drug: olanzapine/placebo
olanzapine - 5 mg/day to 20 mg/day, oral placebo - oral

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00394095

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

Locations
United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45267-0559
Contact: Jenny Daniels, MA     513-558-0956     jennifer.daniels@psychiatry.uc.edu    
Principal Investigator: Melissa P DelBello, MD            
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Melissa P DelBello, MD University of Cincinnati
  More Information

Responsible Party: University of Cincinnati ( Melissa P. DelBello, MD )
Study ID Numbers: F1D-MC-X304
Study First Received: October 27, 2006
Last Updated: July 21, 2008
ClinicalTrials.gov Identifier: NCT00394095  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
Olanzapine
Body Weight Changes
Mood Disorders
Topiramate
Psychotic Disorders
Weight Gain
Serotonin

Additional relevant MeSH terms:
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Antipsychotic Agents
Serotonin Uptake Inhibitors
Neuroprotective Agents
Protective Agents
Pharmacologic Actions
Anti-Obesity Agents
Serotonin Agents
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009