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Richter and US partner consider further trial for Capriprazine in treatment of major depression

Hungarian drug company Gedeon Richter and US partner Forest Laboratories announced on Monday that they may conduct further Phase II dose-response testing on the antipsychotic agent Cariprazine (RGH-188) in the treatment of major depressive disorder.

While preliminary results of an eight-week Phase II clinical trial indicated no statistical difference between drug-treated and placebo-treated groups of patients, they did show evidence of a treatment effect in the high-dose arm of the study compared to the placebo.

The companies are currently engaged in Phase III trials on the Richter-developed drug for the treatment of schizophrenia and bipolar mania after Phase II trials demonstrated a reduction in symptoms for these disorders.

Richter and Forest Laboratories said that tolerability results for Cariprazine support further investigation. The reported that approximately 3% of patients suffering from major depressive disorder discontinued the Phase II clinical trial of Cariprazine early due to adverse events in both the high-dose and placebo arm of the study, while 1% did so in the low-dose arm.

The trials were conducted using patients diagnosed with major depressive disorder who had failed to respond to at least two anti-depressive therapies.

Forest Laboratories licensed the drug in the United States and Canada in 2004.