The study aims to assess the efficacy and tolerability of risperidone added to lithium, valproate or lamotrigine in patients experiencing a manic episode with depressive or irritable features.
* The study aims to assess the efficacy and tolerability of risperidone added to lithium, valproate or lamotrigine, or any combination of the three, in patients experiencing a manic episode with depressive or irritable symptoms. * To assess the back ground and baseline features associated with response/non-response to risperidone plus mood stabilizer in patients with mania with depressive or irritable features. * To assess the symptomatic dimensions of response of risperidone added to mood stabilizers in patients with mania with depressive or irritable features.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
risperidone will be administered 1-3mg pills, each night, for up to 20 weeks
University of Texas Health Science Center
San Antonio, Texas, United States
Forty percent reduction in YMRS
Time frame: 20 weeks
twenty percent reduction in MADRS
Time frame: 20 weeks
Remission rate, defined as final score of plus or minus eight on YMRS and MADRS
Time frame: 20 weeks
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