Tocilizumab Augmentation in Treatment-Refractory Major Depressive Disorder

Stopped early · Phase 2

Conditions studied: Major Depressive Disorder

In brief

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

Key facts

Study ID

NCT02660528

Run by

Brigham and Women's Hospital

People needed

3

Starts

2016-04-01

Expected to finish

2020-06-01

Last updated by the study team

2020-10-20

Who can join

Age: 30 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Current diagnosis of major depressive episode
• Hamilton Depression Rating Scale (HDRS) score of >20
• In treatment for depression for a minimum of 8 weeks

You may not qualify if…

• 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

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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