NCT04141904

Tofacitinib in Depression (TIDE)

The Effects of the Anti-inflammatory Drug, Tofacitinib on Emotional and Reward Processing in Patients With Treatment-resistant Depression and Elevated High-sensitivity C-reactive Protein

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will test whether 7-10 day administration of the anti-inflammatory drug, tofacitinib, has positive effects on people experiencing treatment-resistant depression compared to placebo.

Detailed description

This study uses a double-blind, placebo-controlled, randomised between groups design to test the hypothesis that, compared to placebo, 7-10 days' administration of tofacitinib 5mg twice daily has positive effects on emotional and reward processing in patients with treatment-resistant depression (TRD) and elevated C-reactive protein (hs-CRP; a marker of inflammation). Patients will have been diagnosed with Major Depressive Disorder using the Structured Clinical Interview for DSM-5 and will have shown non-response to at least 2 adequate antidepressant trials.They will also have a plasma hs-CRP of 1mg/L or greater. During the study patients will continue their antidepressant treatment. Participants will be randomised to receive 7-10 days treatment with either tofacitinib 5 mg twice daily or a matched placebo. This study includes three visits in total: a screening visit; research visit 1 (includes cognitive tests) and research visit 2 (to include an MRI scan as well as cognitive tests).

Conditions

• Depression
• Inflammation

Interventions

Type	Name	Description
DRUG	Tofacitinib 5 MG [Xeljanz]	Tofacitinib 5mg capsules twice a day for 7-10 days
OTHER	Placebo	Placebo capsules twice a day for 7-10 days

Timeline

• Start date: 2020-02-10
• Primary completion: 2022-05-23
• Completion: 2022-05-23
• First posted: 2019-10-28
• Last updated: 2022-08-09

Locations

1 site across 1 country: United Kingdom