The purpose of this study is to determine the safety and efficacy of topiramate in adolescents with manic or mixed episodes of Bipolar I Disorder.
This is a 4-week study to evaluate the safety and effectiveness of topiramate compared to placebo in the treatment of Bipolar I Disorder with an optional 6-month open-label (OL) extension for qualified patients following completion of the study. On Days 1-28 patients will receive placebo or topiramate 2x/day by mouth except for the 1st and last doses which will be a single evening dose and a single morning dose, respectively. Study drug will be titrated in 100-mg increments to 400 mg/day and patients maintained on a stable dose through Day 28. During the OL extension phase, topiramate will be titrated over 5 days to 200 mg/day. After Day 7, topiramate may be tapered down to 100 mg/day or up to 600 mg/day, as clinically indicated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
13
Double-blind period: Up to 400 mg/day (two 100-mg tablets twice a day) for 28 days. OL period: Up to 600 mg/day (three 100-mg tablets twice a day) for at least 6 months.
Double-blind period: Equal number of matching placebo tablets for each of the topiramate tablet strengths twice a day for 28 days.
Change from baseline in total Young Mania Rating Scale (YMRS) score
Time frame: Baseline to Day 28 (or last available observation prior to Day 28).
Change from baseline in Clinical Global Impression Scale (CGI-S) score
Time frame: Baseline to Day 28 (or last available observation prior to Day 28).
Change from baseline in Children's Global Assessment Scale (C-GAS) score
Time frame: Baseline to Day 28 (or last available observation prior to Day 28).
The number of patients continuing to meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for manic or mixed episodes of Bipolar I Disorder
Time frame: Day 28 (or last available observation prior to Day 28)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.