Neurocrine Biosciences has revealed that GSK561679, a corticotropin releasing factor (CRF1) receptor antagonist for the treatment of major depressive disorder, has failed to meet the primary or secondary endpoints of a Phase II clinical trial.
The six-week, placebo-controlled, double-blind and randomised study involved 150 patients experiencing a major depressive episode. It was conducted by GlaxoSmithKline (GSK) under the GSK/Neurocrine CRF1 collaboration in the US.
Patients were randomised to receive 350mg of GSK561679 daily or a placebo. The primary endpoint of the study was change in the Bech Melancholia scale from baseline and secondary endpoint was change in the HAMD-17 scale from baseline, both measured after six weeks.
Statistical analysis showed that GSK561679 did not demonstrate a change in the Bech Melancholia and HAMD-17 endpoints when compared to the placebo.
The drug was well-tolerated and there were no significant adverse events.
Three separate clinical trials of GSK561679 for the treatment of post-traumatic stress disorder, anxiety and alcoholism are in progress.