Comparing two medications for treating anhedonia in major depression

Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Desvenlafaxine Succinate Sustained-release Tablets Targeting Anhedonia in Patients With Major Depression Disorder: a Multicentre, Open-label, Parallel-group, Randomised Controlled Trial

This study tests whether a new medication can help people with major depression who have trouble feeling pleasure, comparing it to a different medication over eight weeks.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Jiangsu Province Nanjing Brain Hospital (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06270433 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets compared to desvenlafaxine succinate sustained-release tablets in patients with major depression disorder experiencing anhedonia. It involves 80 participants aged 18 to 65 who meet DSM-5 criteria for major depression. Patients are randomly assigned to receive one of the two medications for an 8-week period, with follow-ups at 2, 4, and 8 weeks to assess treatment outcomes and record any adverse events.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 diagnosed with major depression disorder and experiencing significant anhedonia.

Not a fit: Patients with severe self-injury or psychotic disorders, or those allergic to the study medications, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from anhedonia associated with major depression.

How similar studies have performed: While this specific comparison may be novel, similar studies evaluating the efficacy of antidepressants have shown promising results.

Eligibility criteria

Inclusion Criteria:

* Subjects meet the diagnostic criteria for major depression disorder in the Diagnostic and Statistical Manual of Manual Disorders, fifth Edition (DSM-5);
* Male or female aged ≥18 and ≤65 years;
* Subjects who have a Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥24 points;
* Subjects who have a total score of Snaith-Hamilton Pleasure Scale (SHARPS) ≥3 points;
* Subjects voluntarily participate in the study and sign the informed consent form.

Exclusion Criteria:

* Allergic or known to be allergic to toludesvenlafaxine hydrochloride sustained-release tablets and desvenlafaxine succinate sustained-release tablets;
* Subjects have a severe self-injury/clear suicide attempt or behavior; Scores on MADRS items factor 10 ≥4 points;
* Subjects who meet the diagnostic criteria for any other psychotic disorders (except for major depression disorder) in DSM-5, or those who have substance disorders or drug abuse within the past six months;
* Individuals with severe and unstable physical diseases such as cardiovascular disease, liver disease, kidney disease, blood disorders, and endocrine disorders;
* Hypertensive patients with poor blood pressure control (systolic blood pressure (SBP) ≥140 mmHg or diastolic blood pressure (DBP) ≥90 mmHg at screening);
* Total bilirubin (TBIL) values 1.5 times / alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2 times / creatinine (Cr) 1.2 times higher than the upper limit of normal, or Thyroid-stimulating hormone (TSH) outside the normal range at screening;
* Electrocardiogram (ECG) abnormalities that are clinically significant at period of screening and that the investigator considers as inappropriate conditions for inclusion, such as QTc interval \>450 ms in men and QTc interval \>460 ms in female;
* Pregnant or lactating women, recent planned pregnancy and unable to ensure effective contraception during the period;
* Other conditions that the investigator considers the participant is not suitable for the study.

Where this trial is running

Nanjing, Jiangsu

• Nanjing Brian Hospital — Nanjing, Jiangsu, China (Recruiting)

Conditions Anhedonia