Major Depressive Disorder
Conditions
Brief summary
This proposed study sets out to examine the antidepressant effects of tocilizumab among patients with treatment-refractory major depression.
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.
Interventions
DRUGTocilizumab
Subcutaneous tocilizumab
Sponsors
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change on Hamilton Depression Rating Scale (HDRS) | Baseline to 8 Weeks | Absolute change on Hamilton Depression Rating Scale (HDRS) score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Achieving Remission (HDRS Score < 7) | 8 Weeks | Proportion of Subjects with an HDRS score \< 7 |
| Proportion of Subjects Achieving Response (HDRS Score Decreased >50% From Baseline) | 8 Weeks | Proportion of Subjects with an HDRS score decreased \>50% from baseline |
Countries
United States
Participant flow
Pre-assignment details
No participants were assigned to treatment arms because none of the participants were eligible to continue the study after screening.
Participants by arm
| Arm | Count |
|---|---|
| Baseline Demographics Demographics of screened subjects. | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | Baseline Demographics |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 55.67 years STANDARD_DEVIATION 2.52 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 3 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Absolute Change on Hamilton Depression Rating Scale (HDRS)
Absolute change on Hamilton Depression Rating Scale (HDRS) score
Time frame: Baseline to 8 Weeks
Population: No data was collected for the study outcome measures because none of the participants were eligible to continue the study after screening.
Secondary
Proportion of Subjects Achieving Remission (HDRS Score < 7)
Proportion of Subjects with an HDRS score \< 7
Time frame: 8 Weeks
Population: No data was collected for the study outcome measures because none of the participants were eligible to continue the study after screening.
Secondary
Proportion of Subjects Achieving Response (HDRS Score Decreased >50% From Baseline)
Proportion of Subjects with an HDRS score decreased \>50% from baseline
Time frame: 8 Weeks
Population: No data was collected for the study outcome measures because none of the participants were eligible to continue the study after screening.