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

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

Tracking Information
First Submitted Date  ICMJE October 27, 2006
First Posted Date  ICMJE October 31, 2006
Results First Submitted Date  ICMJE March 23, 2011
Results First Posted Date  ICMJE April 4, 2013
Last Update Posted Date April 4, 2013
Study Start Date  ICMJE December 2006
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2013)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00394095 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2013)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topiramate vs. Placebo in Preventing Weight Gain in Bipolar Disorder Treated With Olanzapine
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Bipolar Disorder
  • Weight Gain
Intervention  ICMJE
  • Drug: Topiramate
    Oral topiramate 300-400mg/day for 12 weeks
    Other Name: Topamax
  • Drug: Placebo
    Matched placebo to Experimental arm
    Other Name: Sugar pill
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Topiramate
  • Placebo Comparator: Placebo Group
    Sugar pill
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 3, 2013)
31
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00394095
Other Study ID Numbers  ICMJE F1D-MC-X304
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Melissa Delbello, University of Cincinnati
Study Sponsor  ICMJE University of Cincinnati
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Principal Investigator: Melissa P DelBello, MD University of Cincinnati
PRS Account University of Cincinnati
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP