Fast-Fail Trials in Mood and Anxiety Spectrum Disorders; Kappa Opioid Receptor Phase 2a
Status:
Completed
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
Summary
The available treatment for patients with mood and anxiety disorders have significant
limitations (Rush, 2007; Denys and de Geus, 2005). There is a need to develop new treatments
for people with these disorders. Many research studies carried out in animals and a few
preliminary studies carried out in humans suggest that medications which block kappa opioid
receptors (KOR) have potential for being effective new treatments for patients with mood and
anxiety spectrum disorders. These medications have shown particular promise for improving one
important type of difficulty experienced by many patients who suffer from mood and anxiety
spectrum disorders referred to as anhedonia, which is an impairment in reward-related
function. In this study we will test the hypothesis that KOR antagonism is a promising means
of improving anhedonia in patients with mood and anxiety spectrum disorders. We will do so by
evaluating whether we can establish Proof of Concept (POC) that a relatively selective KOR
antagonist, CERC-501 (formerly known as LY2456302), engages neural circuits involved in
mediating reward-related function in patients with mood and anxiety spectrum disorders with
anhedonia. We are attempting to establish POC in this study in order to determine whether
there is a sufficient basis for pursuing future work evaluating whether KOR antagonism has
therapeutic effects on clinical and behavioral measures of reward-related functioning.
Phase:
Phase 2
Details
Lead Sponsor:
Andrew Krystal Duke University
Collaborators:
Baylor College of Medicine Case Western Reserve University Duke University Icahn School of Medicine at Mount Sinai Indiana University Yale University