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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 has been completed.
First Received: October 27, 2006   Last Updated: October 9, 2009   History of Changes
Sponsor: 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

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

Resource links provided by NLM:


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
Study Completion Date: September 2009
Primary Completion Date: August 2009 (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

Locations
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267-0559
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Melissa P DelBello, MD University of Cincinnati
  More Information

No publications provided

Responsible Party: University of Cincinnati ( Melissa P. DelBello, MD )
Study ID Numbers: F1D-MC-X304
Study First Received: October 27, 2006
Last Updated: October 9, 2009
ClinicalTrials.gov Identifier: NCT00394095     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Olanzapine
Psychotropic Drugs
Antiemetics
Neuroprotective Agents
Body Weight
Signs and Symptoms
Affective Disorders, Psychotic
Pathologic Processes
Mental Disorders
Therapeutic Uses
Body Weight Changes
Topiramate
Disease
Tranquilizing Agents
Bipolar Disorder
Gastrointestinal Agents
Central Nervous System Depressants
Weight Gain
Antipsychotic Agents
Protective Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Anti-Obesity Agents
Serotonin Agents
Autonomic Agents
Mood Disorders

ClinicalTrials.gov processed this record on November 27, 2009