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

NCT06026917 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-10-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Yantai University

    collaborator UNKNOWN
  • Shanghai Mental Health Center

    lead OTHER

Principal Investigators

  • YIFENG SHEN, MD · Shanghai Mental Health Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-25
Primary Completion
2024-01-31
Completion
2024-03-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06026917 on ClinicalTrials.gov