Clinical Trial: Proof-of-Concept Trial of CERC-501 Augmentation of Antidepressant Therapy in Treatment-Resistant Depression

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Double-Blind, Placebo-Controlled, Proof-of-Concept (POC) Trial of CERC-501, a Kappa-Selective Opioid Receptor Antagonist, Augmentation of Antidepressant Therapy in Treatment-Resi

Brief Summary: This study is looking at the efficacy, rapidity, safety, and tolerability of two doses of oral CERC-501 for treating patients with treatment resistant depression who are taking an antidepressant that is not working for them.

Detailed Summary: This study will involve 10 visits to the clinical site over approximately 1.5 months. There will be a screening visit (7-28 days may pass between the screening visit and the first treatment visit), a baseline/treatment visit (first day of study drug treatment), followed by 5 consecutive days of treatment visits. Follow-up visits will occur 6, 13, and 20 days after first receiving study drug.
Sponsor: Massachusetts General Hospital

Current Primary Outcome: Hamilton Rating Scale for Depression - 6 items [ Time Frame: Past 24 hours ]

Original Primary Outcome: Hamilton Rating Scale for Depression - 6 items [ Time Frame: Past 48 hours ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Massachusetts General Hospital

Dates:
Date Received: July 30, 2013
Date Started: April 2015
Date Completion: December 2016
Last Updated: February 8, 2016
Last Verified: February 2016