NCT03516604

PF-04995274 and Emotional Processing in Un-medicated Depression

The Effects of PF-04995274 on Emotional Processing in Un-medicated Depressed Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (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 administration of a serotonin receptor subtype 4 (5HT4) agonist called PF-04995274 has positive effects on cognition, emotional processing and neural activity in unmedicated depressed patients compared to placebo. The study will also include a group of patients randomised to seven days administration of citalopram (20 mg), which is a standard treatment for depression.

Detailed description

This study uses a double-blind, placebo-controlled, randomised between-groups design to test if administration of a serotonin receptor subtype 4 (5HT4) agonist called PF-04995274 has positive effects on emotional processing and neural activity in unmedicated depressed patients. Participants are patients who fulfill criteria for current episode of Major Depressive Disorder (MDD), and they will be randomised to receive 7 days treatment with either PF-04995274 (15 mg daily), citalopram (20 mg daily) or a matched placebo. Participants will come for a Screening Visit, a First Dose Visit, Research Visit One (including MRI scan) and Research Visit Two (including measures of emotional processing and non-emotion cognition).

Conditions

• Depression, Unipolar

Interventions

Type	Name	Description
DRUG	PF-04995274	PF-04995274 tablets
DRUG	Citalopram	Citalopram capsule
DRUG	Placebo Oral Tablet	Placebo tablet, identical to PF-04995274 tablet
DRUG	Placebo oral capsule	Placebo capsule, identical to citalopram capsule

Timeline

• Start date: 2018-05-16
• Primary completion: 2022-07-29
• Completion: 2022-07-29
• First posted: 2018-05-04
• Last updated: 2022-11-03

Locations

1 site across 1 country: United Kingdom