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New treatment option for Major Depressive Disorder
Official title Neutralizing Interleukin (IL)-6
ClinicalTrials.gov ID: NCT07493317
What this study is testing
What is Tocilizumab?
Tocilizumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for major depressive disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The proposed study aims to establish the feasibility and safety of subcutaneous tocilizumab, a monoclonal antibody (mAb) against interleukin (IL)-6 receptor, in adults with Major Depressive Disorder (MDD) and evidence of peripheral immune activation. IL-6 is a pro-inflammatory cytokine implicated in the pathophysiology of depression.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 8 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- For MDD participants:
- Written informed consent;
- Ability to comply with the requirements of the study as determined by the PI;
- Ages 18-70 years;
- Any gender;
You likely can't join if
- For MDD Participants
- A primary DSM-5 psychiatric diagnosis other than MDD, with the exception of comorbid anxiety disorders (including agoraphobia, generalized anxiety...
- History of schizophrenia, schizoaffective disorder, other psychotic disorder, MDD with psychotic features, or bipolar I or II disorder.
- Diagnosis of a major neurocognitive disorder.
- Moderate or severe substance use disorder within the past 6 months (excluding nicotine use disorder).
- Positive urine toxicology screen for illicit substances at screening.
See the full eligibility criteria
- For MDD participants:
- Written informed consent;
- Ability to comply with the requirements of the study as determined by the PI;
- Ages 18-70 years;
- Any gender;
- DSM-5 diagnosis of MDD in a current Major Depressive Episode;
- Immune enrichment criterion: elevated monocyte count ≥ 500 cells/μL at screening;
- If patient is on antidepressant medication, they must be on a stable dose for ≥4 weeks prior to treatment;
- SHAPS score ≥20
- If female of childbearing potential, must agree to use of a medically accepted form of contraception, or else agree to abstinence until 6 months after the last dose of study drug;
- Male patients, if heterosexually active with a partner who is female of childbearing potential, pregnant, or breastfeeding, must agree to barrier contraception for the treatment period and for at least 6 months after...
- Meet all MRI safety criteria. For Healthy Volunteers:
- Written informed consent;
- Ability to comply with the requirements of the study as determined by the PI;
- Ages 18-70
- Any gender;
- No current or past DSM-5 psychiatric disorder;
- Meet all MRI safety criteria.
- For MDD Participants
- A primary DSM-5 psychiatric diagnosis other than MDD, with the exception of comorbid anxiety disorders (including agoraphobia, generalized anxiety disorder, social anxiety disorder, panic disorder) and post-traumatic...
- History of schizophrenia, schizoaffective disorder, other psychotic disorder, MDD with psychotic features, or bipolar I or II disorder.
- Diagnosis of a major neurocognitive disorder.
- Moderate or severe substance use disorder within the past 6 months (excluding nicotine use disorder).
- Positive urine toxicology screen for illicit substances at screening.
- Serious or imminent risk of self-harm or violence, as determined by the PI, including:
- Suicide attempt within the past 2 years, or
- C-SSRS ideation score \>2 within the past month.
- Any contraindication to MRI, including claustrophobia, retained metallic foreign bodies, magnetic implants or pacemakers, or inability to tolerate MRI procedures.
- Clinically significant abnormalities on physical examination or laboratory testing.
- Unstable or clinically significant medical illness, including but not limited to hepatic, renal, gastrointestinal, respiratory, cardiovascular (including ischemic heart disease), endocrine, neurologic (including history...
- Evidence of active or untreated infection, including
- Active tuberculosis (TB) or untreated latent TB
- Positive QuantiFERON-TB Gold test at screening
- Known HIV infection
- Active Hepatitis B or Hepatitis C infection
- Current or recent (within an appropriate washout period) use of biologic therapies or other immunosuppressive agents (PRN NSAIDs permitted).
- Known hypersensitivity to tocilizumab or its excipients.
- Receipt of a live or live-attenuated vaccine within 30 days prior to first dose, or planned receipt during the study period.
- Pregnancy, breastfeeding, or unwillingness to use effective contraception during the study and for 6 months after the last dose.
- Any condition that, in the opinion of the PI, would compromise participant safety or data integrity. For Healthy Volunteers
- Any current or unstable medical illness, including hepatic, renal, gastrointestinal, respiratory, cardiovascular (including ischemic heart disease), endocrine, neurologic (including history of severe head injury)...
- Use of biologic therapies or immunosuppressive agents (PRN NSAIDs permitted).
- Positive urine toxicology screen for illicit substances at screening.
- Pregnancy at the time of baseline assessments (e.g., MRI).
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.