NCT03515733 (RESTART) is a Phase 1 clinical trial of PF-04995274 in Depression, Unipolar, sponsored by University of Oxford.

Who is sponsoring NCT03515733?

NCT03515733 is sponsored by University of Oxford.

What drugs are being tested in NCT03515733?

Interventions in NCT03515733: PF-04995274, Placebo Oral Tablet.

What condition does NCT03515733 study?

NCT03515733 studies Depression, Unipolar, Treatment Resistant Depression.

Is NCT03515733 still recruiting?

NCT03515733 is currently completed. Last updated 4 November 2022.

Last reviewed 2022-11-04 · How we verify

NCT03515733: RESTART

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

PF-04995274 and Emotional Processing in Treatment Resistant Depression

Completed Phase 1 Last updated 4 November 2022

What this trial tests

Phase 1 trial testing PF-04995274 in Depression, Unipolar in 54 participants. Completed in 26 July 2022.

Timeline

31 May 2018

Primary endpoint
26 July 2022

26 July 2022

Quick facts

Lead sponsor	University of Oxford
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	basic science
Enrollment	54
Start date	31 May 2018
Primary completion	26 July 2022
Estimated completion	26 July 2022
Sites	1 location across United Kingdom

Drugs / interventions tested

PF-04995274 — full drug profile →
Placebo Oral Tablet — full drug profile →

Conditions studied

Depression, Unipolar — all drugs for Depression, Unipolar →
Treatment Resistant Depression — all drugs for Treatment Resistant Depression →

Sponsor

University of Oxford

Who can join

Adults 16 to 65, any sex, with Depression, Unipolar or Treatment Resistant Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Novel drug developmental strategies for treatment-resistant depression.
Borbély É, Simon M, Fuchs E, Wiborg O, et al · · 2022 · cited 70× · PMID 34822719 · DOI 10.1111/bph.15753
Translating the promise of 5HT<sub>4</sub> receptor agonists for the treatment of depression.
Murphy SE, de Cates AN, Gillespie AL, Godlewska BR, et al · · 2021 · cited 41× · PMID 32241310 · DOI 10.1017/s0033291720000604
An overview of structure-based activity outcomes of pyran derivatives against Alzheimer's disease.
Almalki FA. · · 2023 · cited 5× · PMID 37234350 · DOI 10.1016/j.jsps.2023.04.030

Verify or expand the search:

Other trials of PF-04995274

Trials testing the same drug.

NCT03516604 — PF-04995274 and Emotional Processing in Un-medicated Depression · Phase 1 · completed

Other recruiting trials for Depression, Unipolar

Currently open trials in the same condition.

NCT06973759 — Adjunctive Bright Light Therapy in Adolescents With Depression and Eveningness · NA · recruiting
NCT06462196 — Natural History of Depression, Bipolar Disorder and Suicide Risk · recruiting
NCT06392867 — Intermittent Theta-burst Stimulation for Major Depression: an Intensity-response Study · NA · recruiting
NCT06139159 — CRISOL Mente: A Multilevel Community Intervention to Reduce Mental Health Disparities Among Latinos · NA · active not recruiting
NCT06092411 — Effects of CBT and BLT in Youth With Unipolar Depression and Evening Chronotype · NA · recruiting

Other University of Oxford trials

Trials by the same sponsor.

NCT05380388 — A Safety, Immunogenicity and Efficacy Study of PvRII/Matrix-M in Healthy Thai Adults Living in Thailand ( MIST3 ) · Phase 2 · not yet recruiting
NCT07470424 — A Clinical Study of Piperaquine, Pyronaridine, and Artesunate Administered in Combination in Healthy Adults · Phase 1 · not yet recruiting
NCT07345910 — Environment, Pathogens, and Host Interactions in Melioidosis · not yet recruiting
NCT07434973 — Stratification and Treatment in Early Psychosis Study - PROMOTE · Phase 3 · not yet recruiting
NCT07460401 — 'Do Patient Characteristics Associate With Poor Outcome With Femoral Acetabular Impingement Syndrome (FAIS) Following Ph · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03515733 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Oxford
Last refreshed: 4 November 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03515733.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing