Tocilizumab as Add-On Treatment For Residual Positive, Negative, and Cognitive Symptoms of Schizophrenia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02034474|
Recruitment Status : Completed
First Posted : January 13, 2014
Results First Posted : December 26, 2018
Last Update Posted : December 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder||Drug: Tocilizumab Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Tocilizumab, An IL-6 Receptor Antibody, As Add-On Treatment For Residual Positive, Negative, and Cognitive Symptoms of Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial|
|Actual Study Start Date :||February 2014|
|Actual Primary Completion Date :||February 6, 2017|
|Actual Study Completion Date :||February 6, 2017|
Tocilizumab will be administered at day 0, week 4 and week 8 via an iv drip over 60 min. Dose is 8mg/kg but may be reduced to 4mg/kg if intolerable. Maximum dose will be 800mg.
8mg/kg intravenously via iv drip over 60 min
Other Name: Actemra
Placebo Comparator: Placebo
Placebo will be administered intravenously via an iv drip over 60 min
intravenously via iv drip over 60 min
Other Name: Saline Drip
- Clinical Response to Tocilizumab [ Time Frame: Baseline (start of tocilizumab) through 12 weeks. We present the change scores ]To evaluate an anticipated clinical response to tocilizumab treatment including positive, negative and cognitive symptoms by the change in the Positive and Negative Syndrome Scale (PANSS) total score. Score ranges from 30 to 210 for PANSS total, 16-112 for General, 7-49 for positive and 7-49 for negative symptoms subscales. A lower score means less symptomatic. There is a total score and general psychopathology scores, a positive symptoms score and a negative symptom score. The unit of measure is units on a scale from 1-7, whole numbers only. Summed scores are simply added to each other
- Cognitive Symptomatology - Overall MATRICS t Score Change [ Time Frame: Baseline (start of tocilizumab) through 12 weeks ]MATRICS cognitive consensus battery, overall t score change. The composite T-score at each time point (baseline and week 12) is a T-Score (ranging from 0 to 100) reflecting overall neuropsychological function, aggregated from the participant's T-scores on the MATRICS subscales for Speed of Processing, Attention/Vigilance, Working Memory, Verbal Learning, Visual Learning, Reasoning and Problem Solving, and Social Cognition. The outcome is the difference between overall composite T-score at baseline and week 12, with higher difference score reflecting a greater improvement in neuropsychological performance.
- Cognitive Symptomatology - UPSA-B Score Change [ Time Frame: Baseline (start of tocilizumab) through 12 weeks ]At Baseline and Week 12, participants are UPSA-B given items reflecting ability to complete tasks encountered in daily life, across two domains, Financial Skills and Communication Skills. % correct is calculated for each domain and converted to a standardized score from 0-50. These scores are summed to produce a total summary score ranging from 0-100. The outcome is the difference between this summary score at Baseline and Week 12, with a higher difference score reflecting a greater increase in functional capacity.
- Relationship Between Baseline IL-6 Levels and Positive, Negative and Cognitive Symptoms and Impairment [ Time Frame: Baseline (start of tocilizumab) through 12 weeks ]Comparison of cytokines, in particular IL-6 levels and the positive, negative and cognitive symptoms and impairments in daily functioning in schizophrenia. These outcomes will be measured by Positive and Negative Syndrome Scale (PANSS), Global Assessment of Functioning (GAF), Clinical Global Impression (CGI), University of California Performance Skills Assessments (UPSA) and MATRICS.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034474
|United States, New York|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Ragy R Girgis, MD||New York State Psychiatric Institute|