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Topiramate vs. Placebo in Preventing Weight Gain in Bipolar Disorder Treated With Olanzapine

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. Identifier: NCT00394095
Recruitment Status : Completed
First Posted : October 31, 2006
Results First Posted : April 4, 2013
Last Update Posted : April 4, 2013
Eli Lilly and Company
Information provided by (Responsible Party):
Melissa Delbello, University of Cincinnati

Brief 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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Weight Gain Drug: Topiramate Drug: Placebo Phase 4

Detailed Description:
After consent and screening, patients will be initiated on 5mg or 10mg per day of olanzapine. Olanzapine doses will be titrated to 10-20 mg of olanzapine over one week, to a maximum of 20mg by day 21. Patients will also receive either topiramate (25mg bid titrated over 18 days to 150 mg bid. with flexibility to titrate to 200mg bid) or matched placebo. Topiramate will be initiated at a dose of 25 mg bid and will be increased by 25 mg bid every three days as tolerated. Patients will be evaluated by a blinded (to treatment status and adverse events) rater.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : December 2006
Actual Primary Completion Date : August 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Topiramate

Arm Intervention/treatment
Experimental: Topiramate Group
Patients' initial dose of topiramate 25mg bid, which was titrated over 18 days to 150 mg bid (with flexibility to titrate to 200mg bid) as tolerated.
Drug: Topiramate
Oral topiramate 300-400mg/day for 12 weeks
Other Name: Topamax

Placebo Comparator: Placebo Group
Sugar pill
Drug: Placebo
Matched placebo to Experimental arm
Other Name: Sugar pill

Primary Outcome Measures :
  1. Change in Body Mass Index (BMI) [ Time Frame: 12 weeks ]
    For all participants, BMI was computed using Change in BMI [kg/m2 (weight/height2)] over 12 weeks from Baseline to Week 12.

  2. Change in Body Weight [ Time Frame: 12 weeks ]
    For all participants, change in body weight in kg over 12 weeks from Baseline to Week 12.

Secondary Outcome Measures :
  1. Tolerability of Topiramate [ Time Frame: 12 weeks ]
    To examine the tolerability of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder.

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.

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00394095

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United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267-0559
Sponsors and Collaborators
University of Cincinnati
Eli Lilly and Company
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Principal Investigator: Melissa P DelBello, MD University of Cincinnati
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Responsible Party: Melissa Delbello, Professor, University of Cincinnati Identifier: NCT00394095    
Other Study ID Numbers: F1D-MC-X304
First Posted: October 31, 2006    Key Record Dates
Results First Posted: April 4, 2013
Last Update Posted: April 4, 2013
Last Verified: April 2013
Keywords provided by Melissa Delbello, University of Cincinnati:
Bipolar Disorder
Weight Gain
Additional relevant MeSH terms:
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Body Weight
Weight Gain
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Body Weight Changes
Hypoglycemic Agents
Physiological Effects of Drugs