Tocilizumab Augmentation in Treatment-Refractory Major Depressive Disorder

October 16, 2020 updated by: Jessica Harder, Brigham and Women's Hospital

Tocilizumab Augmentation in Treatment-Refractory Major Depressive Disorder: An Open-Label Trial

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

As the understanding of the complex relationship between pro-inflammatory cytokines (specifically interleukin-6 [IL-6]) and depression symptoms becomes clearer, clinical trials to evaluate effective and novel treatments are needed. As there have been no published tocilizumab trials among patients with major depression, this pilot study will adopt a single-arm, open-label design. Due to the notion that inflammatory cytokines may play a role in a sub-type of depression, this study will recruit patients with treatment refractory major depressive disorder, for whom established depression treatments have not been effective. In conducting this trial, the investigators seek to examine the potential role of tocilizumab as an augmentation agent, with the hypothesis that it could reduce depression symptomatology in patients with major depression who have not experienced symptom reduction through more traditional antidepressant therapies.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tocilizumab
Tocilizumab 162 mg sc q2weeks x 4 doses
Drug: Tocilizumab
Subcutaneous tocilizumab
Other Names:
  • Actemra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute Change on Hamilton Depression Rating Scale (HDRS)
Time Frame: Baseline to 8 Weeks
Absolute change on Hamilton Depression Rating Scale (HDRS) score
Baseline to 8 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Subjects Achieving Remission (HDRS Score < 7)
Time Frame: 8 Weeks
Proportion of Subjects with an HDRS score < 7
8 Weeks
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
8 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2016

Primary Completion (ACTUAL)

June 1, 2020

Study Completion (ACTUAL)

June 1, 2020

Study Registration Dates

First Submitted

January 19, 2016

First Submitted That Met QC Criteria

January 19, 2016

First Posted (ESTIMATE)

January 21, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 20, 2020

Last Update Submitted That Met QC Criteria

October 16, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015P001263

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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