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

Primary Purpose

Major Depressive Disorder

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Toludesvenlafaxine hydrochloride sustained-release tablets
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and female outpatients aged 18 years and older; Meet DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) diagnostic criteria for depression (296.2/296.3), and not accompanied by psychotic features; A Montgomery - Asberg Depression Rating Scale (MADRS) total score ≥ 26 at screening; Anhedonia scale score < 28.5 at screening; Subjects and their partners take effective non-drug contraceptive measures (such as abstinence and condom with intravaginal spermicide) throughout the study and within 6 months after the end of the study, and have no sperm donation plan; The subject is willing to participate in the trial and sign the informed consent form and is able to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures. Exclusion Criteria: Known to have a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution (defined as allergy to two or more drugs or food) and the investigator determines that it is not appropriate to participate in the trial; Significant suicide attempt or behavior, MADRS scale item 10 (suicidal ideation) score ≥ 4 points; Pregnant or lactating women, recently planned pregnancy; Those who meet DSM-5 diagnosis of schizophrenia spectrum or other psychoses, bipolar or related disorders, obsessive-compulsive and related disorders, traumatic and stress-related disorders, dissociative disorders, anorexia nervosa or bulimia, personality disorders, substance-related or alcohol use disorders (except nicotine or caffeine); Patients with depression secondary to other mental or physical diseases or with a past medical history or family history of movement disorders (such as Parkinson's disease); Receipt of any contrast agent or radiopharmaceutical within 48 hours before the application of the trial drug, or planned application of contrast agent within 24 hours after the administration of the trial drug; Contraindications to PET or MRI (magnetic resonance imaging) (including claustrophobia, alcohol allergy, cardiac pacemaker and neurostimulator in the body, metal foreign body or tracer component allergy, etc.); in the past 10 years,Major occupational exposure to ionizing radiation (e.g., more than 50 nanovolts/year) or exposure to radioactive substances or ionizing radiation for therapeutic or research purposes; Patients who stopped antidepressant drugs for less than 7 half-lives (at least 2 weeks for monoamine oxidase inhibitors and at least 1 month for fluoxetine) before entering the group; History of gastrointestinal disease known to interfere with drug absorption or excretion or history of surgery known to interfere with drug absorption or excretion; History of increased intraocular pressure or narrow glaucoma; Total bilirubin (TBIL) value 1.5 times higher than the upper limit of normal, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 3 times higher than the upper limit of normal, thyroid stimulating hormone (TSH) higher than the normal range or glomerular filtration rate (GFR) ≤ 70 mL/min at screening or baseline; Patients with serious unstable cardiovascular disease, liver disease, kidney disease, blood disease, endocrine disease, central nervous system and other physical diseases or medical history, or the subjects are not suitable for the study judged by the investigator.

Sites / Locations

  • Shanghai Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Toludesvenlafaxine hydrochloride sustained-release tablets

Arm Description

40 mg/tablet, 80mg/tablet, 40 mg~160mg each time, once a day, for 42 days

Outcomes

Primary Outcome Measures

Percentage of Dopamine Transporters Occupancy in the Basal Ganglia(Positron emission tomography with 11C-CFT) was determine by SUVr of the Basal Ganglia DAT.

Secondary Outcome Measures

Changes in the total score of 10 items on the Montgomery-Asperger's Depression Scale (MADRS) from baseline
Changes in the Scores anhedonia
Incidence Rate of Adverse event

Full Information

First Posted
August 31, 2023
Last Updated
October 18, 2023
Sponsor
Shanghai Mental Health Center
Collaborators
Yantai University
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1. Study Identification

Unique Protocol Identification Number
NCT06026917
Brief Title
Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 25, 2023 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center
Collaborators
Yantai University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Toludesvenlafaxine hydrochloride sustained-release tablets
Arm Type
Experimental
Arm Description
40 mg/tablet, 80mg/tablet, 40 mg~160mg each time, once a day, for 42 days
Intervention Type
Drug
Intervention Name(s)
Toludesvenlafaxine hydrochloride sustained-release tablets
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Dopamine Transporters Occupancy in the Basal Ganglia(Positron emission tomography with 11C-CFT) was determine by SUVr of the Basal Ganglia DAT.
Time Frame
from baseline to day 14 and 42
Secondary Outcome Measure Information:
Title
Changes in the total score of 10 items on the Montgomery-Asperger's Depression Scale (MADRS) from baseline
Time Frame
from baseline to day 42
Title
Changes in the Scores anhedonia
Time Frame
from baseline to day 42
Title
Incidence Rate of Adverse event
Time Frame
from baseline to day 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female outpatients aged 18 years and older; Meet DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) diagnostic criteria for depression (296.2/296.3), and not accompanied by psychotic features; A Montgomery - Asberg Depression Rating Scale (MADRS) total score ≥ 26 at screening; Anhedonia scale score < 28.5 at screening; Subjects and their partners take effective non-drug contraceptive measures (such as abstinence and condom with intravaginal spermicide) throughout the study and within 6 months after the end of the study, and have no sperm donation plan; The subject is willing to participate in the trial and sign the informed consent form and is able to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures. Exclusion Criteria: Known to have a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution (defined as allergy to two or more drugs or food) and the investigator determines that it is not appropriate to participate in the trial; Significant suicide attempt or behavior, MADRS scale item 10 (suicidal ideation) score ≥ 4 points; Pregnant or lactating women, recently planned pregnancy; Those who meet DSM-5 diagnosis of schizophrenia spectrum or other psychoses, bipolar or related disorders, obsessive-compulsive and related disorders, traumatic and stress-related disorders, dissociative disorders, anorexia nervosa or bulimia, personality disorders, substance-related or alcohol use disorders (except nicotine or caffeine); Patients with depression secondary to other mental or physical diseases or with a past medical history or family history of movement disorders (such as Parkinson's disease); Receipt of any contrast agent or radiopharmaceutical within 48 hours before the application of the trial drug, or planned application of contrast agent within 24 hours after the administration of the trial drug; Contraindications to PET or MRI (magnetic resonance imaging) (including claustrophobia, alcohol allergy, cardiac pacemaker and neurostimulator in the body, metal foreign body or tracer component allergy, etc.); in the past 10 years,Major occupational exposure to ionizing radiation (e.g., more than 50 nanovolts/year) or exposure to radioactive substances or ionizing radiation for therapeutic or research purposes; Patients who stopped antidepressant drugs for less than 7 half-lives (at least 2 weeks for monoamine oxidase inhibitors and at least 1 month for fluoxetine) before entering the group; History of gastrointestinal disease known to interfere with drug absorption or excretion or history of surgery known to interfere with drug absorption or excretion; History of increased intraocular pressure or narrow glaucoma; Total bilirubin (TBIL) value 1.5 times higher than the upper limit of normal, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 3 times higher than the upper limit of normal, thyroid stimulating hormone (TSH) higher than the normal range or glomerular filtration rate (GFR) ≤ 70 mL/min at screening or baseline; Patients with serious unstable cardiovascular disease, liver disease, kidney disease, blood disease, endocrine disease, central nervous system and other physical diseases or medical history, or the subjects are not suitable for the study judged by the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YIFENG SHEN, MD
Phone
+8618017311040
Email
shenyifeng@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YIFENG SHEN, MD
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yifeng SHEN, MD
Phone
86-21-34773657
Email
shenyifeng@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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