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NCT05905120

Assessing Dopamine Transporter Occupancy in the Healthy Adult Brain With Toludivenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET)

Completed Phase 1 Last updated 27 July 2023
What this trial tests

Phase 1 trial testing Toludivenlafaxine hydrochloride sustained-release tablets in Major Depressive Disorder in 6 participants. Completed in 26 July 2023.

Timeline
2 March 2023
Primary endpoint
30 June 2023
26 July 2023

Quick facts

Lead sponsorShanghai Mental Health Center
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment6
Start date2 March 2023
Primary completion30 June 2023
Estimated completion26 July 2023
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Shanghai Mental Health Center — full company profile →

Who can join

Adults 18 to 45, male only, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study was a single-arm, non-randomized, open-label clinical study to assess dopamine transporter occupancy in the brain of healthy adults using 11C-CFT positron emission tomography (PET)

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. PET/CT study of dopamine transporter (DAT) binding with the triple reuptake inhibitor toludesvenlafaxine in rats and humans.
    Huang Z, Wu J, Guan Y, Wei Y, et al · · 2024 · cited 3× · PMID 38587645 · DOI 10.1007/s00259-024-06700-2

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Other recruiting trials for Major Depressive Disorder

Currently open trials in the same condition.

Other Shanghai Mental Health Center trials

Trials by the same sponsor.

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