NCT02363738View on ClinicalTrials.gov

12-Week Study Evaluating the Efficacy, Safety, and Tolerability of Adjunctive Infliximab for Bipolar I/II Depression

PHASE2CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

April 30, 2017

Study Completion Date

April 30, 2017

Conditions
Bipolar Depression
Interventions
DRUG

Infliximab

Intravenous infliximab (5mg/kg) at baseline, week 2 and 6 under clinical observation. Infliximab will be prescribed adjunctively to a conventional mood stabilizer or atypical antipsychotic agent.

OTHER

Saline

Intravenous placebo (saline solution) at baseline, week 2 and 6 under clinical observation. Placebo will be matched to infliximab in color and consistency and will be administered adjunctively to conventional mood stabilizer or atypical antipsychotic agent.

Trial Locations (2)

94304

VA Palo Alto Health Care System, Palo Alto

M5T2S8

Toronto Western Hospital, Toronto

All Listed Sponsors
collaborator

Clinical Investigation Centre for Innovative Technology Network

NETWORK

collaborator

Stanford University

OTHER

lead

University Health Network, Toronto

OTHER

NCT02363738 - 12-Week Study Evaluating the Efficacy, Safety, and Tolerability of Adjunctive Infliximab for Bipolar I/II Depression | Biotech Hunter | Biotech Hunter