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
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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