Assessing brain dopamine levels in patients with depression using a specific medication

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)

This study is testing how a specific depression medication affects dopamine levels in the brains of people with Major Depressive Disorder to see if it helps improve their symptoms.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Mental Health Center (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06026917 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the occupancy of dopamine transporters in the brains of patients diagnosed with Major Depressive Disorder using 11C-CFT positron emission tomography (PET). It is a single-arm, open-label study where participants will receive toludesvenlafaxine hydrochloride extended-release tablets. The study aims to understand how this medication affects dopamine levels in the brain, which may provide insights into its efficacy for treating depression. Participants will be monitored for their response to the treatment through various assessments.

Who should consider this trial

Good fit: Ideal candidates are male and female outpatients aged 18 and older who meet the DSM-5 criteria for Major Depressive Disorder without psychotic features.

Not a fit: Patients with a history of allergy to the investigational drug or similar medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of dopamine's role in depression and improve treatment strategies for patients.

How similar studies have performed: Other studies have explored dopamine transporter occupancy in depression, but this specific approach using toludesvenlafaxine is relatively novel.

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.

Where this trial is running

Shanghai, Shanghai

• Shanghai Mental Health Center — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Yifeng Shen, Md — Shanghai Mental Health Center
• Study coordinator: Yifeng Shen, Md

Conditions Major Depressive Disorder