NCT03516604 (RESTAND) is a Phase 1 clinical trial of PF-04995274 in Depression, Unipolar, sponsored by University of Oxford.

Who is sponsoring NCT03516604?

NCT03516604 is sponsored by University of Oxford.

What drugs are being tested in NCT03516604?

Interventions in NCT03516604: PF-04995274, Citalopram, Placebo Oral Tablet, Placebo oral capsule.

What condition does NCT03516604 study?

NCT03516604 studies Depression, Unipolar.

Is NCT03516604 still recruiting?

NCT03516604 is currently completed. Last updated 3 November 2022.

Last reviewed 2022-11-03 · How we verify

NCT03516604: RESTAND

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 Un-medicated Depression

Completed Phase 1 Last updated 3 November 2022

What this trial tests

Phase 1 trial testing PF-04995274 in Depression, Unipolar in 90 participants. Completed in 29 July 2022.

Timeline

16 May 2018

Primary endpoint
29 July 2022

29 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	90
Start date	16 May 2018
Primary completion	29 July 2022
Estimated completion	29 July 2022
Sites	1 location across United Kingdom

Drugs / interventions tested

PF-04995274 — full drug profile →
Citalopram (CITALOPRAM) — full drug profile →
Placebo Oral Tablet — full drug profile →
Placebo oral capsule

Conditions studied

Depression, Unipolar — all drugs for Depression, Unipolar →

Sponsor

University of Oxford

Who can join

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

Sponsor's own description

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.

Publications & conference data

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

Translating the promise of 5HT4 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
Memory Disorders Related to Hippocampal Function: The Interest of 5-HT4Rs Targeting.
Roux CM, Leger M, Freret T. · · 2021 · cited 19× · PMID 34769511 · DOI 10.3390/ijms222112082
Early effects of a novel 5-HT4R agonist (PF-04995274) and the SSRI citalopram on emotional cognition in unmedicated depression: RESTAND study.
Gillespie AL, de Cates AN, Scaife J, Blandhol M, et al · · 2026 · PMID 42204761 · DOI 10.1192/bjp.2026.10664
Early effects of a novel 5-HT4 agonist (PF-04995274) and the SSRI citalopram on emotional cognition in unmedicated depression: the RESTAND study
Gillespie A, de Cates A, Scaife J, Blandhol M, et al · · 2025 · DOI 10.1101/2025.08.28.25334462

Verify or expand the search:

Other trials of PF-04995274

Trials testing the same drug.

NCT03515733 — PF-04995274 and Emotional Processing in Treatment Resistant 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 NCT03516604 (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: 3 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/NCT03516604.

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