2013年1月24日讯 /生物谷BIOON/ --梯瓦（Teva）今天宣布，在双相情感障碍相关重度抑郁症患者中开展的有关armodafinil（nuvigil）的第二项III期研究（Study 3072）未能达到研究的主要和次要终点。该项研究旨在确定日服150mg armodafinil作为情绪稳定剂或非典型抗精神病药物的辅助治疗是否比安慰剂更为有效。
英文原文：Teva second Phase III depression study of armodafinil fails to meet endpoints
PBR Staff Writer
Published 24 January 2013
Teva Pharmaceutical Industries second Phase III study of armodafinil (nuvigil) conducted in patients with major depression associated with bipolar 1 disorder has failed to meet primary and secondary endpoints.
Study 3072, second of three, Phase III studies, has not achieved statistical significance to meet primary endpoint although numerical improvement was established.
The study was designed to determine if 150mg of armodafinil administered each day is more effective as adjunct therapy for mood stabilizers and/or atypical antipsychotics compared to placebo.
Teva Global R&D president and chief scientific officer Michael Hayden said the company is committed to clinical development program with the ongoing third phase III trial, on the basis of positive results from the first trial, a trend observed in the second one, and comparable safety results between the studies.
"Bipolar 1 disorder is a complex disease where there remains a significant unmet patient need to successfully treat associated depressive episodes," Hayden added.
"We believe that armodafinil may have a unique mechanism of action in patients with depression associated with bipolar 1 disorder, and we will continue to study it as adjunct therapy in adults with this debilitating disease."
First pivotal study 3071 demonstrated positive results.
