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Tocilizumab Augmentation in Treatment-Refractory Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Jessica Harder, Brigham and Women's Hospital

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Tocilizumab Phase 2

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 Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tocilizumab
Tocilizumab 162 mg sc q2weeks x 4 doses
 Drug: Tocilizumab
Subcutaneous tocilizumab
Other Name: Actemra


Outcome Measures
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Primary Outcome Measures :
  1. Absolute Change on Hamilton Depression Rating Scale (HDRS) [ Time Frame: Baseline to 8 Weeks ]
    Absolute change on Hamilton Depression Rating Scale (HDRS) score


Secondary Outcome Measures :
  1. Proportion of Subjects Achieving Remission (HDRS Score < 7) [ Time Frame: 8 Weeks ]
    Proportion of Subjects with an HDRS score < 7

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Jessica Harder, MD Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Jessica Harder, Brigham and Women's Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] August 7, 2019

More Information
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Publications:

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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
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms