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

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.

Conditions

• Treatment Resistant Depression

Interventions

DRUG

CERC-501

Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days). High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days). For patients randomly assigned to the placebo/low-dose drug sequence, the patient will receive placebo for 3 days and then 10 mg/day CERC-501 for the following 3 days. For patients randomly assigned to the placebo/high-dose drug sequence, the patient will receive placebo for 3 days and then 20 mg/day CERC-501 for the following 3 days.

DRUG

Placebo

For patients randomly assigned to the placebo/ placebo sequence, study medication will be placebo during the first phase (3 days) and during the second phase (3 days). For patients randomly assigned to the placebo/low-dose drug sequence, the patient will receive placebo for 3 days and then 10 mg/day CERC-501 for the following 3 days. For patients randomly assigned to the placebo/high-dose drug sequence, the patient will receive placebo for 3 days and then 20 mg/day CERC-501 for the following 3 days.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Butler Hospital

  collaborator OTHER

• Rush University

  collaborator OTHER

• Temple University

  collaborator OTHER

• University of Kansas

  collaborator OTHER

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Maurizio Fava, MD · Massachusetts General Hospital (Coordinating Center)

• Linda L Carpenter, MD · Brown University-Butler Hospital

• John Zajecka, MD · Rush University

• Mary F Morrison, MD · Temple University

• Matthew Macaluso, DO · University of Kansas

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-09-12

Primary Completion

2016-01-22

Completion

2016-01-22

Countries

• United States

Study Locations