NCT03515733

PF-04995274 and Emotional Processing in Treatment Resistant Depression

The Effects of PF-04995274 on Emotional Processing in Treatment-resistant, Medicated, Depressed Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will test whether seven days adjunctive administration of a serotonin receptor subtype 4 (5HT4) agonist called PF-04995274 has positive effects on emotional processing and non-emotional cognition in medicated, treatment-resistant depressed patients compared to placebo.

Detailed description

This study uses a double-blind, placebo-controlled, randomised between-groups design to test if adjunctive administration of a serotonin receptor subtype 4 (5HT4) agonist called PF-04995274 has positive effects on emotional processing and neural activity in medicated treatment-resistant depressed patients. Participants are patients who fulfill criteria for current episode of Major Depressive Disorder (MDD) and have shown lack of response to antidepressant treatment, and they will be randomised to receive 7 days treatment with either PF-04995274 (15 mg daily) or a matched placebo. Participants will come for a Screening Visit, a First Dose Visit, and a Research Visit (including measures of emotional processing and non-emotion cognition).

Conditions

• Depression, Unipolar
• Treatment Resistant Depression

Interventions

Type	Name	Description
DRUG	PF-04995274	PF-04995274 tablets
DRUG	Placebo Oral Tablet	Placebo tablet, identical appearance to experimental tablet

Timeline

• Start date: 2018-05-31
• Primary completion: 2022-07-26
• Completion: 2022-07-26
• First posted: 2018-05-04
• Last updated: 2022-11-04

Locations

1 site across 1 country: United Kingdom