Forest Laboratories and Gedeon Richter have reported preliminary top-line results from a Phase III clinical trial of Cariprazine (RGH-188), an investigational anti-psychotic agent, used to treat patients with acute mania associated with bipolar I disorder.

Discovered by researchers at Gedeon Richter, Cariprazine is an orally active, potent dopamine D3-preferring D3/D2 receptor partial agonist, which is currently being investigated in clinical studies for patients with schizophrenia, bipolar depression, and as an adjunct treatment for major depressive disorder.

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The Phase III multicentre double-blind placebo-controlled parallel-group study is designed to examine the efficacy, safety and tolerability of Cariprazine monotherapy in patients with acute mania associated with bipolar I disorder.

During the five-week study, 497 men and women aged 18-65 years were randomised into three treatment groups and received at least one dose of either Cariprazine 3-6mg/day, Cariprazine 6-12 mg/day or placebo.

The Young Mania Rating Scale (YMRS) is a comprehensive, clinician-rated instrument used to evaluate the severity of mania in bipolar patients, including parameters such as elevated mood, increased motor activity-energy, sleep and irritability.

In the study, the primary protocol-specified endpoint was change from baseline to week three on the YMRS, using the mixed-effects model of repeated measures (MMRM) analyses.

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The trial demonstrated that patients treated with Cariprazine experienced considerable improvements in symptoms compared to placebo-treated patients observed as early as day five of treatment and at each subsequent time point studied.

The study also showed that overall premature discontinuation rates were 23% for Cariprazine 3-6mg/day, 30% for Cariprazine 6-12mg/day, and 24% for placebo.

Marco Taglietti, MD, senior vice president of research and development and president, Forest Research Institute, said: "These positive phase III results further demonstrate the opportunity for cariprazine as a potential new treatment option for patients suffering from bipolar mania."

Gedeon Richter research director Zsolt Szombathelyi said: "In the three consecutive positive trials, statistically significant results demonstrated improvement in symptoms compared to placebo, importantly including the low dose range arm."