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

PHASE2TerminatedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

September 12, 2013

Primary Completion Date

January 22, 2016

Study Completion Date

January 22, 2016

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."

Trial Locations (4)

Unknown

Rush University, Chicago

University of Kansas, Wichita

Temple University, Philadelphia

Brown University-Butler Hospital, Providence

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

collaborator

Butler Hospital

OTHER

collaborator

Rush University

OTHER

collaborator

Temple University

OTHER

collaborator

University of Kansas

OTHER

lead

Massachusetts General Hospital

OTHER

NCT01913535 - Proof-of-Concept Trial of CERC-501 Augmentation of Antidepressant Therapy in Treatment-Resistant Depression | Biotech Hunter | Biotech Hunter