An Open-Label Trial of Tocilizumab in Schizophrenia
This study is a Phase 1 clinical trail to determine the safety, tolerability, and efficacy of Tocilizumab (Actemra) as an adjunct to antipsychotic medications in stable outpatients with schizophrenia. Tocilizumab (structural formula C6428H9976N1720O2018S42) is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) IgG1 subclass. Tocilizumab is formulated as a concentrate for solution for infusion, and will be administered by intravenous infusion.
The investigators propose an 8-week trial to determine the safety, tolerability, and effectiveness of tocilizumab, given in addition to antipsychotic medications, in 10 stable outpatients with schizophrenia. The investigators hypothesize that tocilizumab will be associated with clinically significant improvement in cognition and total psychotic symptoms over the course of the trial. Tocilizumab is administered as an intravenous infusion every 4 weeks. Following a screening evaluation, participants will receive two infusions of tocilizumab, one at baseline and another at week 4 of the study. The investigators will measure changes in cognitive function and symptoms over an 8-week period. Complementing previous positive clinical trials of non-steroidal anti-inflammatory drugs, this would be a "proof-of-concept" study that targeting specific cytokines is a viable treatment for schizophrenia.
Interleukin 6 and its receptor were discovered and cloned at Osaka University, Japan, by Tadamitsu Kishimoto in the 1980s. In 1997, Chugai Pharmaceuticals began the clinical development of tocilizumab for the treatment of rheumatoid arthritis. Clinical studies for Castleman's disease and systemic juvenile idiopathic arthritis started in 2001 and 2002, respectively. Hoffmann-La Roche co-developed the drug due to a license agreement in 2003.
Data presented in 2008 showed the effectiveness of tocilizumab in combination therapy with methotrexate for RA treatment. In further studies, it was effective and generally well tolerated when administered either as monotherapy or in combination with conventional DMARDs in adult patients with moderate to severe rheumatoid arthritis.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Trial of Tocilizumab in Schizophrenia|
- Improvement in Cognition [ Time Frame: Change from baseline in Cognition at 8 weeks ] [ Designated as safety issue: No ]The Brief Assessment of Cognition in Schizophrenia (BACS)is the metric used to characterize cognition in this study.
- Improvement in Total Psychotic Symptoms [ Time Frame: Change from baseline in Total Psychotic Symptoms at 8 weeks ] [ Designated as safety issue: No ]The Clinical Global Impression (CGI) and Positive and Negative Symptoms Scale (PANSS)are the metrics used to characterize psychotic symptoms in this study.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Following a screening evaluation, participants will receive two infusions of tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of tocilizumab, the recommended starting dose for adults with RA.
Therapeutic/Pharmacologic Class of Drug:
Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) IgG1 subclass.
Type of Dosage Form:
Concentrate for solution for infusion.
Route of Administration:
Intravenous (i.v.) infusion.
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|Contact: Brian Miller, MD, PhD, MPHfirstname.lastname@example.org|
|United States, Georgia|
|Georgia Health Sciences University||Recruiting|
|Augusta, Georgia, United States, 30912|
|Contact: Brian Miller, MD, PhD, MPH 706-721-4445 email@example.com|
|Principal Investigator: Brian Miller, MD, PhD, MPH|
|Sub-Investigator: Peter F Buckley, MD|
|Principal Investigator:||Brian Miller, MD, PhD, MPH||Georgia Health Sciences University Department of Psychiatry and Health Behavior|