MONTREUX, Switzerland, Feb. 4 /PRNewswire/ -- Patients with frequently relapsing bipolar disorder had a significant delay in the time to an initial relapse when risperidone long-acting injection (RLAI) was combined with standard treatment, according to a new study. The study compared patients who received RLAI and standard treatment to those who received standard treatment combined with placebo.
The study was presented yesterday at the 14th Biennial Winter Workshop on Schizophrenia and Bipolar Disorders in Montreux, Switzerland.(1) This one-year, phase 3, trial is the first placebo-controlled study to explore the use of a long-acting injection medication in the maintenance treatment of frequently relapsing bipolar disorder (FRBD). FRBD, defined as four or more manic or depressive episodes in the previous year that require a doctor's care, may affect 20% of the 27 million people with bipolar disorder worldwide(2,3).
The study compared the time to the next mood episode, also known as a relapse, in FRBD patients receiving RLAI plus standard treatment vs. patients receiving placebo plus standard treatment. For most patients, standard treatment consisted of mood stabilizers, antidepressants, anxiolytics or combinations thereof. The trial showed that time to relapse was significantly longer in patients receiving RLAI compared with placebo (p=0.004) and the relative risk of relapse was 2.4 times higher with placebo. The relapse rates were 47.8% with placebo and 22.2% with RLAI.
"Patients with frequently relapsing bipolar disorder require more
healthcare interventions than patients with fewer episodes, and there is a
huge unmet need for new treatments," said Dr. Joseph Calabrese, Co-Director
of the Bipolar Disorders Research Center, University Hospitals Case Medical
Center, Case Western Reserve University. Dr. Calabrese is a consultant to
the study sponsors, Ortho-McNeil Janssen Scientific Affairs, L.L.C.
"Risperidone long-acting injection is adm
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