Tocilizumab as Add-On Treatment For Residual Positive, Negative, and Cognitive Symptoms of Schizophrenia

Part of paid clinical trials in New York, New York.

Sponsor
New York State Psychiatric Institute
Study ID
NCT02034474
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 59 Years
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    8mg/kg intravenously via iv drip over 60 min
  • Placebo — DRUG
    intravenously via iv drip over 60 min

Study Details

Randomized, double-blind clinical trial of tocilizumab vs. placebo as add-on treatment for residual positive, negative, and cognitive symptoms in schizophrenia. The primary study hypothesis is that individuals receiving tocilizumab will show greater improvements in their PANSS total scores than those taking placebo.

Key Dates

Start date
Feb 28, 2014
Status verified
Dec 2018
Primary completion
Feb 6, 2017
Completion
Feb 6, 2017

Study Design

Enrollment
59 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: tocilizumab
    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.
  • Placebo Comparator: Placebo
    Placebo will be administered intravenously via an iv drip over 60 min

Primary Outcome Measure

Clinical Response to Tocilizumab [ Time Frame: Baseline (start of tocilizumab) through 12 weeks. We present the change scores ]

Locations (1)

FacilityCityStateZIPSite coordinators
New York State Psychiatric InstituteNew YorkNew York10032-

Find similar trials in New York, NY

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
New York State Psychiatric Institute· New York, NY

Related Studies