Tofacitinib in Depression (TIDE) (TIDE)
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|ClinicalTrials.gov Identifier: NCT04141904|
Recruitment Status : Suspended (Covid-19 pandemic)
First Posted : October 28, 2019
Last Update Posted : November 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Depression Inflammation||Drug: Tofacitinib 5 MG [Xeljanz] Other: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be randomly allocated to one of two groups (tofacitinib or placebo) and take the assigned medication for 7-10 days|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|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|
|Actual Study Start Date :||February 10, 2020|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2021|
Tofacitinib 5mg capsule twice a day for 7-10 days
Drug: Tofacitinib 5 MG [Xeljanz]
Tofacitinib 5mg capsules twice a day for 7-10 days
Placebo Comparator: Placebo
Placebo capsule twice a day for 7-10 days
Placebo capsules twice a day for 7-10 days
- The effects of tofacitinib on emotional processing using the Facial Expression Recognition Task (FERT) [ Time Frame: Day 7-10 of drug/placebo administration ]Accuracy and reaction times on computer-based tasks of emotional processing using facial expressions of basic emotions (happiness, fear, anger, disgust, sadness, surprise) are displayed on the screen and participants are asked to correctly classify them. Each emotion is presented at different intensity levels. Responses are made via a button-press and accuracy and reaction time are recorded
- The effects of tofacitinib on Emotional Memory Task (EMEM) scores [ Time Frame: Day 7-10 of drug/placebo administration ]Recall and recognition of affective words displayed earlier in the testing session is tested
- Emotional categorization using the Emotional categorization task (ECAT) [ Time Frame: Day 7-10 of drug/placebo administration ]Disagreeable or agreeable personality descriptions are presented and participants are asked to indicate whether they would like or dislike to be described as each of these characteristics. Responses are made via a button-press.
- Emotional recall task (EREC) [ Time Frame: Day 7-10 of drug/placebo administration ]Participants are asked to write down as many of the words as they can remember from the previous task. Responses are made via pencil and paper.
- Brain neural activity [ Time Frame: Day 7-10 of drug/placebo administration ]BOLD fMRI at resting state and during the performance of an emotional (i.e. covert facial expression processing) and a reward (i.e. adapted probabilistic instrumental learning) processing tasks.
- Faces dot probe task (FDOT) [ Time Frame: Day 7-10 of drug/placebo administration ]Participants carry out computer-based tasks and attentional vigilance to happy or fearful faces is recorded from participants' response latency to indicate the alignment of a dot probe appearing in the place of one of the faces
- Probabilistic Instrumental Learning Task (PILT) [ Time Frame: Day 7-10 of drug/placebo administration ]Participants have to learn which shapes are associated with wins and losses and sensitivity to reward is measured.
- Auditory Verbal Learning Task (AVLT) [ Time Frame: Day 7-10 of drug/placebo administration ]Accuracy of recall on the auditory verbal learning task
- The effects of tofacitinib on cerebral perfusion [ Time Frame: Day 7-10 of drug/placebo administration ]Arterial spin labelling at rest to measure cerebral perfusion
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04141904
|Department of Psychiatry, University of Oxford|
|Oxford, Oxfordshire, United Kingdom, OX3 7JX|
|Principal Investigator:||Philip J Cowen||University of Oxford|