Tocilizumab Augmentation in Treatment-Refractory Major Depressive Disorder

• Status: Terminated
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This proposed study sets out to examine the antidepressant effects of tocilizumab among patients with treatment-refractory major depression.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital

Criteria

Inclusion Criteria:

• Current diagnosis of major depressive episode

• Hamilton Depression Rating Scale (HDRS) score of >20

• In treatment for depression for a minimum of 8 weeks

Exclusion criteria:

• Active drug or alcohol disorder in the last three months

• History of psychosis, mania or hypomania

• Acute suicide or homicide risk

• History of liver disease including HCV and HBV

• HIV

• History of heart disease or a heart attack

• Active or latent tuberculosis, a history of a positive tuberculosis test, or having received the Bacillus Calmette-Guérin (BCG) vaccine

• Epilepsy or a history of seizures

• Abnormal thyroid-stimulating hormone (TSH <0.4 or >5.0mlU/L)

• Abnormal liver function tests on screening (ALT>50 U/L or AST>50 U/L)

• Low absolute neutrophil count (ANC) on screening (<4000/mm3

• Abnormal white blood cell count (<4,500 or > 10,000mcL)

• Low platelet count on screening (<150,000/mm3

• Patients with an active or recent infection, for example cellulitis, bacteremia, pneumonia, and pyelonephritis.

• Recent exposure to uncommon infections (e.g. histoplasmosis, blastomycosis, coccidiomycosis) through recent travel to the Ohio and Mississippi River Valleys and the Southwest

• Pregnant women, breastfeeding women or women of child-bearing age not using contraception

• History of or current autoimmune disease, including multiple sclerosis and inflammatory bowel disease

• Diagnosis of chronic fatigue syndrome

• Temperature greater than 100.3F at the screening visit or any subsequent visits

• Dyslipidemia

• Currently taking oral steroids

• Currently taking statins

• Chronic aspirin or NSAID takers

• Currently taking any immunomodulating medications

• Inability to consent due to cognitive impairment