Baricitinib for Depression

(JAK DC in Play Trial)

Not yet recruiting at 2 trial locations
AH
Overseen ByAndrew H Miller, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how inflammation might affect depression and cognitive issues, specifically in former football players. Participants will take baricitinib, a medication that reduces inflammation, to determine if it alleviates depressive symptoms. The trial seeks men who have played organized football for over ten years and are experiencing symptoms of depression.

As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

You may need to stop taking certain medications. Participants must be off all antidepressant or other psychotropic therapy (like mood stabilizers and antipsychotics) for at least 4 weeks before the study starts, or be on a stable regimen for at least 4 weeks with no planned changes.

Is there any evidence suggesting that baricitinib is likely to be safe for humans?

Research shows that baricitinib has been tested for safety in various conditions. Studies on COVID-19 patients found no major safety issues with baricitinib use for up to 14 days. Additionally, a large safety review for rheumatoid arthritis showed similar safe results, with a side effect rate of 22.6 per 100 patient years, considered low.

The FDA has already approved baricitinib for conditions like rheumatoid arthritis, indicating general safety. However, safety for use beyond 36 weeks remains under study. Overall, research suggests that baricitinib is well-tolerated.12345

Why do researchers think this study treatment might be promising for depression?

Baricitinib is unique because it targets the Janus kinase (JAK) pathway, which is different from the usual neurotransmitter-focused approach in depression treatments like SSRIs and SNRIs. Most standard treatments for depression, such as fluoxetine or sertraline, work by altering serotonin levels in the brain. However, baricitinib's novel mechanism of action could offer new insights and potential benefits for those who don't respond well to traditional therapies. Researchers are excited about the possibility of baricitinib providing relief for patients with treatment-resistant depression, expanding the current landscape of depression management.

What evidence suggests that baricitinib might be an effective treatment for depression?

Research has shown that baricitinib, a medication that reduces inflammation, might help treat depression. Some studies found it can improve depression symptoms, especially when inflammation levels are high. In trials, baricitinib reduced symptoms more effectively than a placebo. It blocks certain proteins involved in inflammation, which is thought to play a role in depression. While researchers continue to collect more data, early results are promising for people with depression that hasn't responded to other treatments. Participants in this trial will receive baricitinib, starting with a dose of 2 mg daily, with the possibility of increasing to 4 mg daily if there is no clinical response at 4 weeks.36789

Who Is on the Research Team?

AH

Andrew H Miller, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for men who have played organized football for at least 10 years and are experiencing depression or problems with memory or thinking. Participants should not have conditions that would make it unsafe to take the study medication.

Inclusion Criteria

Score greater than 10 on the PHQ-9 from screening and HAM-D score of 16 or higher for study entry
Willing and able to give written informed consent
More than 10 years of playing football, including at least 1 year in the NFL
See 6 more

Exclusion Criteria

Additional exclusion criteria apply
Significant hematological abnormalities at screening (ANC less than 1500, Hgb less than 10, platelet count less than 100,000)
I have had severe or widespread shingles affecting my eyes or nervous system.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take baricitinib once daily for 8 weeks, with dose adjustments based on clinical response. They undergo MRI scans, provide blood and urine samples, and complete assessments of depressive and cognitive symptoms.

8 weeks
Baseline, weeks 2, 4, 6, and 8

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of depressive and cognitive symptoms.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Baricitinib

Trial Overview

The study is testing baricitinib, a medication that reduces inflammation, to see if it can help with depression and cognitive symptoms in former football players. All participants will receive this treatment.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: BaricitinibExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

Citations

Baricitinib for Major Depressive Disorder

Over 36 weeks, related conditions showed improvements in quality of life and depression symptoms. While specific data for MDD is still being gathered, these ...

Treatment Outcomes in Major Depressive Disorder in Patients ...

Chi-squared tests showed no significant difference in response or remission rates from depression between groups across treatment levels. Higher Hamilton Rating ...

Emerging Medications for Treatment-Resistant Depression

Phase 2 and 3 clinical trials have demonstrated efficacy [139,140], and the drug gained regulatory approval for clinical use in non-TRD MDD in China in late ...

Depression Phase Trials for Baricitinib (DB11817)

Depression Phase Trials for Baricitinib (DB11817). Back to Depression. Also known as: Mood Disorder of Depressed Type / Depressed / Depressive / ...

Efficacy and acceptability of anti-inflammatory agents in ...

In conclusion, anti-inflammatory agents, overall, demonstrate significant effectiveness in treating major depressive disorder compared to ...

A Review of Safety Outcomes from Clinical Trials of Baricitinib ...

No safety concerns were observed in hospitalised patients with COVID-19 who received baricitinib for up to 14 days. Identifying the patterns and likelihoods of ...

Integrated safety analysis of baricitinib in adults with severe ...

This analysis includes pooled patient-level safety data from two trials, an adaptive phase II/III trial (BRAVE-AA1) and a phase III trial (BRAVE-AA2) ( ...

BARIcitinib Cognitive Emotional and Neural signaTuRE

The primary outcome is the number of accurate responses in facial emotion recognition task at day 1 using Harmer's cognitive battery (based on Harmer & Cowen ...

Baricitinib (Olumiant)

A pooled safety analysis was conducted, including data for all patients receiving baricitinib during Study. BRAVE-AA1 and Study BRAVE-AA2 up to the data cut ...