WALTHAM, Mass., Sept. 30 /PRNewswire-FirstCall/ — Repligen
RGEN) reported today that it has completed enrollment of
patients in its Phase 2b clinical trial of RG2417, an oral
formulation of uridine, in patients with bipolar depression.
This study is a double-blind, placebo-controlled trial
designed to assess the efficacy of 8 weeks of treatment with RG2417
or a placebo on the symptoms of bipolar depression as measured by
the Montgomery-Asberg Depression Rating Scale (MADRS). The
study enrolled 175 patients at 29 clinical sites within the United
States, and we expect to report top-line results in the first
quarter of 2011.
The primary objective of this study is to assess the safety and
efficacy of RG2417 on the symptoms of bipolar depression by
demonstrating a greater improvement in the MADRS score of the
patients receiving RG2417 when compared to placebo over the 8-week
treatment period. Patients were initially screened for a
score of bipolar depression symptoms of greater than 20 on the
MADRS and subsequently confirmed to meet the criteria for bipolar
depression using an alternate diagnostic tool to ensure that
patients have the appropriate diagnosis for inclusion in the study.
Evaluations for symptoms of depression are conducted at
baseline and then weekly using the MADRS, a standardized,
rater-administered scale, which has been used for numerous drug
trials in bipolar disorder. In addition to the MADRS ratings,
patients conduct a weekly self-assessment of their symptoms, which
is used to cross check the fidelity of the MADRS raters.
Additional secondary and exploratory objectives include
improvements in the Clinical Global Impression Scale, difference in
the end of study MADRS scores, and a lack of increase in mania as
measured by the Young’s Mania Rating Scale.
The average baseline MADRS of the 175 patients