Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT04141904
Status:
TERMINATED
Last Update Posted:
2022-08-09
First Post:
2019-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tofacitinib in Depression (TIDE)
Sponsor:
University of Oxford
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Covid-19 pandemic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TIDE
Brief 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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: