Fast-Fail Trials in Mood and Anxiety Spectrum Disorders; Kappa Opioid Receptor Phase 2a

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.

Conditions

• ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)

Interventions

DRUG

CERC-501

Oral dosing of 10 mg CERC-501 daily for 8 weeks

DRUG

placebo

oral dosing of 10 mg placebo daily for 8 weeks

Sponsors & Collaborators

• Yale University

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• Indiana University

  collaborator OTHER

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• Case Western Reserve University

  collaborator OTHER

• Duke University

  lead OTHER

Principal Investigators

• Richard D Weiner, MD, PhD · Duke University

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-06-30

Primary Completion

2017-11-01

Completion

2017-12-01

Countries

• United States

Study Locations