| NCT ID | NCT07003997 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Emory University |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-09-03 |
| Primary Completion | 2030-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2025-09-03 with a primary completion date of 2030-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. willing and able to give written informed consent; 2. men or women, 25-55 years of age; 3. a primary diagnosis of DSM-V major depression, current, or Bipolar, depressed type as diagnosed by the SCID-V; 4. score of \>14 on the PHQ-9 from screening and HAM-D score ≥18 for study entry; 5. 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), 6. CRP ≥3 mg/L, 7. PHQ-9 anhedonia score ≥2. Exclusion Criteria: 1. history or evidence (clinical and laboratory) of an autoimmune disorder 2. history or evidence (clinical or laboratory) of hepatitis B or C infection or human immunodeficiency virus infection; 3. history of any type of cancer requiring treatment with more than minor surgery; 4. unstable cardiovascular, endocrinologic, hematologic, hepatic, renal, or neurologic disease (as determined by physical examination, EKG and laboratory testing); 5. significant hematological abnormalities at screening (ANC \< 1500, Hgb\<10, platelet\< 100,000) 6. history of progressive multifocal leukoencephalopathy, 7. history of deep venous thrombosis, 8. history of cardiovascular disease (coronary artery disease, congestive heart failure, stroke - controlled hypertension is OK), 9. major surgery within 8 weeks prior to screening or will require major surgery during the study, 10. current or recent (\<4 weeks prior to randomization) viral (including COVID-19), bacterial, fungal, or parasitic infection or any other active or recent infection, 11. symptomatic herpes zoster infection at or within 12 weeks of randomization, 12. history of disseminated/complicated herpes zoster (for example, ophthalmic zoster or CNS involvement), 13. cirrhosis of the liver from any cause, 14. 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 on atazanavir, who must have total bilirubin \<2 x ULN), 15. chronic kidney disease with eGFR \<60 mL/min/1.73 m2, 16. 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); 17. 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 symptoms); 18. history of a cognitive disorder or traumatic head injury involving loss of consciousness; 19. pregnancy or lactation, 20. use of gender affirming hormone therapy; 21. 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 supplements with known or suspected anti-inflammatory properties (e.g. fish oil supplements) within 2 weeks of baseline, or at any time during the study; 22. any contraindication for MRI scanning; 23. failure of more than 2 antidepressant trials (at least 6 weeks at recommended dose) in the current episode or 5 antidepressant trials lifetime; and 24. 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.
Contact & Investigator
Jennifer Felger, PhD
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT07003997 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 55 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07003997 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07003997 currently recruiting?
Yes, NCT07003997 is actively recruiting participants. Contact the research team at jfelger@emory.edu for enrollment information.
Where is the NCT07003997 trial being conducted?
This trial is being conducted at Atlanta, United States.
Who is sponsoring the NCT07003997 clinical trial?
NCT07003997 is sponsored by Emory University. The principal investigator is Jennifer Felger, PhD at Emory University. The trial plans to enroll 100 participants.