The primary objective of this study is to compare the efficacy and tolerability of quetiapine versus divalproex extended-release administered in a rapid oral loading fashion in the treatment of acute episodes of mania or mixed mania in bipolar disorder. Three hypotheses will be tested: Hypothesis 1: treatment ( 3 weeks) of divalproex extended-release is similar to quetiapine in the symptomatic control of mania or mixed mania Hypothesis 2: divalproex extended-release orally loaded may produce significant improvements in symptoms of mania sooner than quetiapine Hypothesis 3: divalproex extended-release may produce significantly less sedation
This will be a rater-blinded, head-to-head comparison (no placebo) of divalproex ER and quetiapine in patients with symptoms of an active manic or mixed mania (symptoms of mania and depression). Forty subjects are expected to be enrolled. After screening for eligibility, eligible subjects will be randomized while hospitalized in a 1:1 ratio into 2 treatment groups: divalproex ER or quetiapine. Depakote® ER will be given orally at 30 mg/kg day initially taken at night and rounded up to nearest 500 mg dose with adjustments made through the trial as needed to obtain serum valproic acid levels of 85-125 mcg/ml. Quetiapine will be given orally at an initial dose of 200mg/day on Day 1, and titrate up to 800 mg/day. The duration of the study will be 21 days from baseline and the total number of visits including screening is five. Patients will be released from the hospital once stable and visits for the study will then take place on an outpatient basis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Dose: 30mg per kg, rounded to nearest 500mg, dosed PO QHS. Adjustments made through trial to obtain serum valproic acid levels of 85-125 mcg/ml
Dose: 200mg PO QHS, titrated up to therapeutic dose of 600-800mg.
UCSD Medical Center
San Diego, California, United States
Primary Measure: Young Mania Rating Scale (YMRS) Primary Endpoint: Day 7
Minimum: 0 Maximum: 60 Higher scores indicate worse outcome
Time frame: Day 7
Young Mania Rating Scale (YMRS) Secondary Endpoints
Time frame: weekly - Day 3, 14, 21
Clinical Global Impression: Severity (CGI:S)
Time frame: each visit
Clinical Global Impression: Improvement (CGI:I)
Time frame: each week/visit
Readiness to Discharge Questionnaire (RDQ)
Time frame: each week/visit in the hospital
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: each week/visit
Behavioral Activity Rating Scale (BARS)
Time frame: each week/visit
Extrapyramidal Symptoms Rating Scale (ESRS)
Time frame: each week/visit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.