For maintenance therapy of adult patients
RISPERDAL CONSTA (risperidone) is the only FDA-approved, long-acting injectable atypical antipsychotic monotherapy forBipolar I Disorder.
Risperdal Consta significantly delayed time to relapse to a mood episode (mania, hypomania, mixed, depression).*
*The study was not powered to draw conclusions for relapse between individual mood states (mania, hypomania, mixed, depression). The majority of relapses were due to manic rather than depressive symptoms.
The most common adverse reaction in a clinical trial in patients with bipolar disorder was weight increase (5% in monotherapy trial).
Monotherapy Trial: Study Design1,2
RISPERDAL® CONSTA® was studied in a multicenter, randomized, double-blind, placebo-controlled clinical trial in 303 patients with Bipolar I Disorder. Patients were enrolled for up to 104 weeks. The median duration of exposure was 280.5 days for RISPERDAL® CONSTA® and 151 for placebo.
Patients received RISPERDAL® CONSTA® doses of 25, 37.5, or 50 mg by intramuscular injection every 2 weeks. Patients who were judged to be stable for at least the last 8 weeks of a 26-week open-label phase were randomized in the double-blind phase. The primary endpoint was time to relapse to any mood episode (depression, mania, hypomania, or mixed).
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JANSSEN® CONNECT™ and CONSTANTAccess™
Both programs provide access and support to you when prescribing INVEGA® SUSTENNA® (paliperdone palmitate) or RISPERDAL® CONSTA® (risperidone). In addition, alternate injection sites of care, continuity of therapy, and distribution support may be available in certain areas.LEARN MORE ABOUT SERVICES AVAILABLE IN YOUR AREA