Tocilizumab Augmentation in Treatment-Refractory Major Depressive Disorder
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ClinicalTrials.gov Identifier: NCT02660528 |
Recruitment Status :
Terminated
(Study staff change.)
First Posted : January 21, 2016
Results First Posted : October 20, 2020
Last Update Posted : October 20, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Major Depressive Disorder | Drug: Tocilizumab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Tocilizumab Augmentation in Treatment-Refractory Major Depressive Disorder: An Open-Label Trial |
Actual Study Start Date : | April 2016 |
Actual Primary Completion Date : | June 2020 |
Actual Study Completion Date : | June 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Tocilizumab
Tocilizumab 162 mg sc q2weeks x 4 doses
|
Drug: Tocilizumab
Subcutaneous tocilizumab
Other Name: Actemra |
- Absolute Change on Hamilton Depression Rating Scale (HDRS) [ Time Frame: Baseline to 8 Weeks ]Absolute change on Hamilton Depression Rating Scale (HDRS) score
- Proportion of Subjects Achieving Remission (HDRS Score < 7) [ Time Frame: 8 Weeks ]Proportion of Subjects with an HDRS score < 7
- Proportion of Subjects Achieving Response (HDRS Score Decreased >50% From Baseline) [ Time Frame: 8 Weeks ]Proportion of Subjects with an HDRS score decreased >50% from baseline

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Ages Eligible for Study: | 30 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT02660528
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Jessica Harder, MD | Brigham and Women's Hospital |
Documents provided by Jessica Harder, Brigham and Women's Hospital:
Responsible Party: | Jessica Harder, Associate Psychiatrist, Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT02660528 |
Other Study ID Numbers: |
2015P001263 |
First Posted: | January 21, 2016 Key Record Dates |
Results First Posted: | October 20, 2020 |
Last Update Posted: | October 20, 2020 |
Last Verified: | October 2020 |
Depressive Disorder Depression Depressive Disorder, Major |
Mood Disorders Mental Disorders Behavioral Symptoms |