RECRUITING

JAK Signaling in Depression

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Janus Kinase (JAK) Signaling in Depression

Quick Facts

Study Start:2025-09-03

Study Completion:2030-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07003997

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Jennifer Felger, PhD

CONTACT

404-727-3987

jfelger@emory.edu

Principal Investigator

Jennifer Felger, PhD

PRINCIPAL_INVESTIGATOR

Emory University

Study Locations (Sites)

Emory University

Atlanta, Georgia, 30322

United States

Collaborators and Investigators

Sponsor: Emory University

Jennifer Felger, PhD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-03

Study Completion Date2030-02

Study Record Updates

Study Start Date2025-09-03

Study Completion Date2030-02

Terms related to this study

Additional Relevant MeSH Terms

Major Depressive Disorder