NCT02660528

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_2 major-depressive-disorder

Timeline
Completed

Started Apr 2016

Longer than P75 for phase_2 major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 21, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
5 months until next milestone

Results Posted

Study results publicly available

October 20, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

4.2 years

First QC Date

January 19, 2016

Results QC Date

September 17, 2020

Last Update Submit

October 16, 2020

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Absolute Change on Hamilton Depression Rating Scale (HDRS)

    Absolute change on Hamilton Depression Rating Scale (HDRS) score

    Baseline to 8 Weeks

Secondary Outcomes (2)

  • Proportion of Subjects Achieving Remission (HDRS Score < 7)

    8 Weeks

  • Proportion of Subjects Achieving Response (HDRS Score Decreased >50% From Baseline)

    8 Weeks

Study Arms (1)

Tocilizumab

EXPERIMENTAL

Tocilizumab 162 mg sc q2weeks x 4 doses

Drug: Tocilizumab

Interventions

TocilizumabDRUG

Subcutaneous tocilizumab

Also known as: Actemra
Tocilizumab

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

  • Sukoff Rizzo SJ, Neal SJ, Hughes ZA, Beyna M, Rosenzweig-Lipson S, Moss SJ, Brandon NJ. Evidence for sustained elevation of IL-6 in the CNS as a key contributor of depressive-like phenotypes. Transl Psychiatry. 2012 Dec 4;2(12):e199. doi: 10.1038/tp.2012.120.

    PMID: 23212583BACKGROUND

  • Al-Hakeim HK, Al-Rammahi DA, Al-Dujaili AH. IL-6, IL-18, sIL-2R, and TNFalpha proinflammatory markers in depression and schizophrenia patients who are free of overt inflammation. J Affect Disord. 2015 Aug 15;182:106-14. doi: 10.1016/j.jad.2015.04.044. Epub 2015 May 5.

    PMID: 25985379BACKGROUND

  • Fonseka TM, McIntyre RS, Soczynska JK, Kennedy SH. Novel investigational drugs targeting IL-6 signaling for the treatment of depression. Expert Opin Investig Drugs. 2015 Apr;24(4):459-75. doi: 10.1517/13543784.2014.998334. Epub 2015 Jan 14.

    PMID: 25585966BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Results Point of Contact

Title
Dr. Jessica Harder
Organization
Brigham and Women's Hospital
jaharder@bwh.harvard.edu
617-525-7919

Study Officials

  • Jessica Harder, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Psychiatrist

Study Record Dates

First Submitted

January 19, 2016

First Posted

January 21, 2016

Study Start

April 1, 2016

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

October 20, 2020

Results First Posted

October 20, 2020

Record last verified: 2020-10

Locations

US(1)