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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Bipolar Disorder
Weight Gain
Interventions Drug: Topiramate
Drug: Placebo
Enrollment 31
Recruitment Details Thirty one bipolar adolescents with a manic or mixed episode (ages 12-18 years) were recruited from the inpatient units and outpatient clinics at the University of Cincinnati and Cincinnati Children’s Hospital Medical Center.
Pre-assignment Details Subjects meeting the entry criteria were randomized to treatment with topiramate or placebo in combination with olanzapine for this 12-week study.
Arm/Group Title Experimental Group: Topiramate Group Comparator Group: Placebo Group
Hide Arm/Group Description Experimental Group Receiving oral Topiramate, 300-400mg/day for 12 weeks Placebo Group Receiving oral placebo 300-400mg/day for 12 weeks
Period Title: Overall Study
Started 17 14
Screened 17 14
Completed 16 14
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Arm/Group Title Experimental Group: Topiramate Group Comparator Group: Placebo Group Total
Hide Arm/Group Description Experimental Group Receiving oral Topiramate, 300-400mg/day for 12 weeks Placebo Group Receiving oral placebo 300-400mg/day for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 17 14 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 14 participants 31 participants
<=18 years
17
 100.0%
14
 100.0%
31
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 14 participants 31 participants
14.6  (1.9) 14.0  (2.0) 14.3  (1.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 14 participants 31 participants
Female
9
  52.9%
8
  57.1%
17
  54.8%
Male
8
  47.1%
6
  42.9%
14
  45.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 14 participants 31 participants
17 14 31
1.Primary Outcome
Title Change in Body Mass Index (BMI)
Hide Description For all participants, BMI was computed using Change in BMI [kg/m2 (weight/height2)] over 12 weeks from Baseline to Week 12.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was per protocol based on change in BMI over 12 weeks in the Experimental sample (N=16) compared to the Placebo group (N=14).
Arm/Group Title Experimental Group: Topiramate Group Placebo Group
Hide Arm/Group Description:
Change in Body Weight in kilograms over 12 weeks in the Experimental Topiramate sample (N=16) compared to the Placebo group (N=14).
Group receiving comparable dosage of placebo over 12 weeks.
Overall Number of Participants Analyzed 16 14
Mean (95% Confidence Interval)
Unit of Measure: kg/m2
0.8
(-.33 to 2.33)
1.8
(1.20 to 11.72)
2.Primary Outcome
Title Change in Body Weight
Hide Description For all participants, change in body weight in kg over 12 weeks from Baseline to Week 12.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Bipolar youth (ages 12-17) who were taking olanzapine (10-20 mg/day) for a manic episode, were given topiramate (300-400mg/day) or comparable dose placebo for 12 weeks. Analysis was per protocol.
Arm/Group Title Experimental Group: Topiramate Group Comparator Group: Placebo Group
Hide Arm/Group Description:
Change in Body Weight in kilograms over 12 weeks in the Experimental Topiramate sample (N=16) compared to the Placebo group (N=14).
Group receiving comparable dosage of placebo over 12 weeks.
Overall Number of Participants Analyzed 16 14
Mean (95% Confidence Interval)
Unit of Measure: kg
2.8
(0.85 to 14.95)
6.4
(0.85 to 14.95)
3.Secondary Outcome
Title Tolerability of Topiramate
Hide Description 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
Outcome Measure Data Not Reported
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental Group: Topiramate Group Comparator Group: Placebo Group
Hide Arm/Group Description Experimental Group Receiving oral Topiramate, 300-400mg/day for 12 weeks Placebo Group Receiving oral placebo 300-400mg/day for 12 weeks
All-Cause Mortality
Experimental Group: Topiramate Group Comparator Group: Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Experimental Group: Topiramate Group Comparator Group: Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/17 (5.88%)      0/14 (0.00%)    
Nervous system disorders     
Hyperthermia  1  1/17 (5.88%)  1 0/14 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, Hyperthermia
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Experimental Group: Topiramate Group Comparator Group: Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      0/14 (0.00%)    
One subject experienced hyperthermia and was admitted to hospital. Subject was discontinued from study.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Melissa DelBello, MD
Organization: University of Cincinnati
Phone: 513-558-4489
EMail: melissa.delbello@uc.edu
Layout table for additonal information
Responsible Party: Melissa Delbello, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00394095     History of Changes
Other Study ID Numbers: F1D-MC-X304
First Submitted: October 27, 2006
First Posted: October 31, 2006
Results First Submitted: March 23, 2011
Results First Posted: April 4, 2013
Last Update Posted: April 4, 2013