Phase 4
Completed N=36
Tocilizumab as Add-On Treatment For Residual Positive, Negative, and Cognitive Symptoms of Schizophrenia
Source: ClinicalTrials.gov NCT02034474 ↗Enrolled (actual)
36
Serious AEs
2.8%
Results posted
Dec 2018
Primary outcomePrimary: Clinical Response to Tocilizumab — -5.33; -0.5 Units on a scale (PANSS)
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Response to Tocilizumab |
-5.33; -0.5 | — |
| SECONDARY Cognitive Symptomatology - Overall MATRICS t Score Change |
2.83; 1.47 | — |
| SECONDARY Cognitive Symptomatology - UPSA-B Score Change |
1.12; 1.12 | — |
Eligibility Criteria
Inclusion Criteria
- Fulfill DSM-IV criteria for schizophrenic illness, schizoaffective disorder
- Negative urine toxicology
- Capacity to understand the study and give written informed consent
- Must be on a stable dose of antipsychotic medications, up to two medications, except for clozapine, for at least 4 weeks if oral or 2 cycles if depot. Mood stabilizers, benzodiazepines and antidepressants are allowed as long as no change for 4 weeks.
- Moderate level of symptomatology
Exclusion Criteria
- Pregnancy or lactation, lack of effective birth control during the 15 days before the initial day of the study and for the duration of the drug trial
- Unstable medical or neurological condition (including chronic rashes other than mild eczema, ANC 150 kg
- Serum creatinine > 1/6mg/dL (141 umol/L) in female patients and > 1.9 mg/dL (168 umol/L) in male patients. Patients with serum creatinine values exceeding limits may be eligible for the study if their estimated glomerular filtration rates (GFR) are > 30
- Total Bilirubin >ULN
- Hemoglobin < 85g/L
- White Blood Cells <3.0 x 10^9/L
- Absolute Lymphocyte Count < 0.5 x 10^9/L
- Positive Hepatitis BsAg or Hepatitis C antibody
Additional Exclusion Criteria for MRI portion
- Metal implants or a history of metal working
- Lifetime diagnosis of asthma with asthmatic symptoms within the past 3 years
- Lifetime diagnosis of renal failure or renal disease
- Lifetime diagnosis of hypertension or diabetes
- Renal insufficiency
- More than one previous gadolinium scan
Data sourced from ClinicalTrials.gov (NCT02034474). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.