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New treatment option for Major Depressive Disorder
Official title JAK Signaling in Depression
ClinicalTrials.gov ID: NCT07003997
What this study is testing
What is Baricitinib?
Baricitinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for major depressive disorder.
Also referred to as Olumiant.
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
- This study will test the hypothesis that Janus kinase (JAK) signaling is involved in major depression (MD) with high inflammation by determining whether its inhibition with baricitinib can improve functional connectivity in reward and motor circuits in association with improved motivation and motor function in MD patients enriched for high C-reactive protein (CRP) and anhedonia.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 55
You may be able to join if
- willing and able to give written informed consent;
- men or women, 25-55 years of age;
- a primary diagnosis of DSM-V major depression, current, or Bipolar, depressed type as diagnosed by the SCID-V;
- score of \>14 on the PHQ-9 from screening and HAM-D score ≥18 for study entry;
- off all antidepressant or other psychotropic therapy (e.g. mood stabilizers, antipsychotics, and sedative hypnotics) for at least 4 weeks prior to...
You likely can't join if
- history or evidence (clinical and laboratory) of an autoimmune disorder
- history or evidence (clinical or laboratory) of hepatitis B or C infection or human immunodeficiency virus infection;
- history of any type of cancer requiring treatment with more than minor surgery;
- unstable cardiovascular, endocrinologic, hematologic, hepatic, renal, or neurologic disease (as determined by physical examination, EKG and...
- significant hematological abnormalities at screening (ANC \< 1500, Hgb\<10, platelet\< 100,000)
- history of progressive multifocal leukoencephalopathy,
See the full eligibility criteria
- willing and able to give written informed consent;
- men or women, 25-55 years of age;
- a primary diagnosis of DSM-V major depression, current, or Bipolar, depressed type as diagnosed by the SCID-V;
- score of \>14 on the PHQ-9 from screening and HAM-D score ≥18 for study entry;
- off all antidepressant or other psychotropic therapy (e.g. mood stabilizers, antipsychotics, and sedative hypnotics) for at least 4 weeks prior to baseline visit (8 weeks for fluoxetine),
- CRP ≥3 mg/L,
- PHQ-9 anhedonia score ≥2.
- history or evidence (clinical and laboratory) of an autoimmune disorder
- history or evidence (clinical or laboratory) of hepatitis B or C infection or human immunodeficiency virus infection;
- history of any type of cancer requiring treatment with more than minor surgery;
- unstable cardiovascular, endocrinologic, hematologic, hepatic, renal, or neurologic disease (as determined by physical examination, EKG and laboratory testing);
- significant hematological abnormalities at screening (ANC \< 1500, Hgb\<10, platelet\< 100,000)
- history of progressive multifocal leukoencephalopathy,
- history of deep venous thrombosis,
- history of cardiovascular disease (coronary artery disease, congestive heart failure, stroke - controlled hypertension is OK),
- major surgery within 8 weeks prior to screening or will require major surgery during the study,
- current or recent (\<4 weeks prior to randomization) viral (including COVID-19), bacterial, fungal, or parasitic infection or any other active or recent infection,
- symptomatic herpes zoster infection at or within 12 weeks of randomization,
- history of disseminated/complicated herpes zoster (for example, ophthalmic zoster or CNS involvement),
- cirrhosis of the liver from any cause,
- any of the following specific abnormalities on screening laboratory tests: ALT or AST \>2 x upper limits of normal (ULN), alkaline phosphatase (ALP) ≥2 x ULN, total bilirubin ≥1.5 x ULN (with the exception of patients...
- chronic kidney disease with eGFR \<60 mL/min/1.73 m2,
- history of any (non-mood-related) psychotic disorder; active psychotic symptoms of any type; substance abuse/dependence within 6 months of study entry (as determined by standardized clinician interview);
- active suicidal plan as determined by a score \>3 on item #3 on the HAM-D; g. an active eating disorder (except for patients with binge eating disorder in whom binging is clearly associated with worsening of mood...
- history of a cognitive disorder or traumatic head injury involving loss of consciousness;
- pregnancy or lactation,
- use of gender affirming hormone therapy;
- chronic use of non-steroidal anti-inflammatory agents (NSAIDS) (excluding 81mg of aspirin), immunosuppressive (e.g., biologics), glucocorticoid containing medications or minocycline within 6 months, or non-prescription...
- any contraindication for MRI scanning;
- failure of more than 2 antidepressant trials (at least 6 weeks at recommended dose) in the current episode or 5 antidepressant trials lifetime; and
- BMI \>45 (to exclude severe obesity) or at the PI's discretion based on the patient's ability to fit comfortably in the MRI scanner.
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, 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.