NCT06026917

Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET)

A Single-Arm, Open-Label, Exploratory Mechanistic Validation (PoM) Clinical Trial of Toludesvenlafaxine Hydrochloride Extended-Release Tablets Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain Using 11C-CFT Positron Emission Tomography (PET)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was a single-arm, open-label clinical study to assess dopamine transporter occupancy in the brain of patients with depression using 11C-CFT positron emission tomography (PET).

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Toludesvenlafaxine hydrochloride sustained-release tablets	D1\~D6, 40mg/ tablet, 1 tablet per time, once a day, D7\~D10, 80mg/ tablet, 1 tablet per time, once a day, D11\~D42, 80mg/ tablet, 2 tablets per time, once a day. For subjects who cannot tolerate 160mg, the dose may be reduced to 80mg/ dose once daily. After the number of subjects receiving 160mg/ dose reached 6, the remaining subjects received D11\~D42, 80mg/ tablet, one tablet each time, once a day.

Timeline

• Start date: 2023-09-25
• Primary completion: 2024-01-31
• Completion: 2024-03-31
• First posted: 2023-09-07
• Last updated: 2023-10-19

Locations

1 site across 1 country: China