NCT01941043

A Randomized, Double-Blind, Placebo-Controlled, Sequential Parallel Study of CERC-301 in the Adjunctive Treatment of Subjects With Severe Depression and Recent Active Suicidal Ideation Despite Antidepressant Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,357 (actual)
• Sponsor: Avalo Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The current study will evaluate the antidepressant effect of CERC-301 during 28 days of treatment in subjects with MDD who are currently experiencing a severe depressive episode despite stable ongoing treatment with selective serotonin- or serotonin-norepinephrine reuptake inhibitors (SSRI or SNRI). The study population will be enriched for subjects that would benefit most from rapid onset, those with recent active suicidal ideation, but not a risk to themselves or others and are deemed appropriate for an out-patient study with careful safety surveillance. This will allow the study to focus on the antidepressant effects of CERC-301 but also explore effects on suicidal ideation. To explore rapid onset, the primary endpoint will be at 7 days, but effects over the 28 days of treatment will be examined as a secondary endpoint.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	CERC-301
OTHER	Placebo

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-09-01
• Completion: 2014-10-01
• First posted: 2013-09-13
• Last updated: 2017-12-21

Locations

24 sites across 1 country: United States