NCT00448058 is a Phase 2 clinical trial of GSK372475 in Depressive Disorder, sponsored by GlaxoSmithKline.

Who is sponsoring NCT00448058?

NCT00448058 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00448058?

Interventions in NCT00448058: GSK372475, venlafaxine, placebo.

What condition does NCT00448058 study?

NCT00448058 studies Depressive Disorder.

Is NCT00448058 still recruiting?

NCT00448058 is currently completed. Last updated 2 October 2014.

Last reviewed 2014-10-02 · How we verify

NCT00448058

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

A Ten-Week, Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Flexible-Dose Study Evaluating the Efficacy, Safety, and Tolerability of GSK372475 (1.5 mg/Day to 2.0 mg/Day) or Extended Release Venlafaxine XR (150 mg/Day to 225 mg/Day) Compared to Placebo in Adult s

Completed Phase 2 Last updated 2 October 2014

What this trial tests

Phase 2 trial testing GSK372475 in Depressive Disorder in 396 participants. Completed in 1 December 2008.

Timeline

1 April 2007

Primary endpoint
1 December 2008

1 December 2008

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	396
Start date	1 April 2007
Primary completion	1 December 2008
Estimated completion	1 December 2008
Sites	42 locations across Australia, Belgium, Bulgaria, Canada, Estonia, Finland, France, Germany

Drugs / interventions tested

GSK372475 — full drug profile →
venlafaxine — full drug profile →
placebo

Conditions studied

Depressive Disorder — all drugs for Depressive Disorder →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 64, any sex, with Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change from randomization to the end of the Treatment Phase (Week 10) on a depression rating scale.
Time frame: Randomisation (week 0) And end of the treatment

Sponsor's own description

To evaluate the efficacy, safety, and tolerability of GSK372475 compared with placebo in the treatment of outpatient subjects with Major Depressive Disorder (MDD)

Publications & conference data

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

Biomarkers for response in major depression: comparing paroxetine and venlafaxine from two randomised placebo-controlled clinical studies.
Carboni L, McCarthy DJ, Delafont B, Filosi M, et al · · 2019 · cited 56× · PMID 31375659 · DOI 10.1038/s41398-019-0521-7
Novel Antidepressants in the Pipeline (Phase II and III): A Systematic Review of the US Clinical Trials Registry.
Sakurai H, Yonezawa K, Tani H, Mimura M, et al · · 2022 · cited 21× · PMID 35045580 · DOI 10.1055/a-1714-9097

Verify or expand the search:

Other trials of GSK372475

Trials testing the same drug.

NCT00728208 — GSK372475 PK Study in Healthy Volunteers · Phase 1 · completed
NCT00420641 — MDD POC Study GSK372475 Subjects Depressive Disease · Phase 2 · completed

Other recruiting trials for Depressive Disorder

Currently open trials in the same condition.

NCT07290153 — Psychological State, Immunotherapy Response, and Multi-Omics Signatures in TNBC · recruiting
NCT07100951 — Comparing Brief Psychoanalytic Couple Therapy and Emotionally Focused Therapy in Reducing Relationship Distress · NA · recruiting
NCT06890208 — Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures, Third Wave · recruiting
NCT06901739 — Therapeutic Potential of a Synbiotic to Improve Mental Health in Subjects With Obesity. · NA · recruiting
NCT06724666 — Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression · NA · recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · 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 NCT00448058 (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 GlaxoSmithKline
Last refreshed: 2 October 2014

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/NCT00448058.

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