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Major Depression DisorderNCT06278038

Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Venlafaxine Hydrochloride Sustained-release Tablets in Patients With Major Depression Disorder

A study testing Toludesvenlafaxine hydrochloride sustained-release tablets and Venlafaxine hydrochloride sustained-release tablets in people with Major Depression Disorder, run by First Affiliated Hospital of Zhejiang University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets in the treatment of major depression disorder compared to venlafaxine hydrochloride sustained-release tablets, to provide evidence-based basis for clinical rational drug use. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Major Depression Disorder
What is being tested?
Toludesvenlafaxine hydrochloride sustained-release tablets and Venlafaxine hydrochloride sustained-release tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteChina
Study dates
22 Feb 2024to 19 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 17-item Hamilton Depression Rating Scale (HAM-D17) total score ≥18 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.

Who cannot join

  • Allergic or known to be allergic to toludesvenlafaxine hydrochloride sustained-release tablets and venlafaxine hydrochloride sustained-release tablets;
  • Subjects have a severe self-injury/clear suicide attempt or behavior; Scores on HAM-D17 items factor 3 ≥3 points;
  • Subjects who meet the diagnostic criteria for any other psychotic disorders in DSM-5;
  • Subjects who meet the diagnostic criteria for substance disorders or alcohol abuse in DSM-5 (except for nicotine or caffeine) 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);
Show all 12Show fewer
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2 times / creatinine (Cr) 1.2 times higher than the upper limit of normal 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;
  • Subjects who received electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within 3 months prior to screening;
  • Subjects who received systematic psychotherapy (interpersonal relationship therapy, dynamic therapy, cognitive behavioral therapy) within 3 months prior to screening;
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

Other trials in China

About this study

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

The purpose of this study is to evaluate efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets in the treatment of major depression disorder compared to venlafaxine hydrochloride sustained-release tablets, to provide evidence-based basis for clinical rational drug use.

Read the detailed description

The study included 80 patients with major depression disorder (aged 18 to 65 years) who meet the diagnostic criteria for depression in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).

Eligible patients were randomly assigned (1:1) to 8-week treatment with toludesvenlafaxine hydrochloride sustained-release tablets (n=40) or venlafaxine hydrochloride sustained-release tablets (n=40), followed up at period of enrollment as baseline and at the end of 2th, 4th and 8th weeks. Adverse events were recorded.

Being tested
Toludesvenlafaxine hydrochloride sustained-release tablets, Venlafaxine hydrochloride sustained-release tablets

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Toludesvenlafaxine hydrochloride sustained-release tabletsDrug

    80 mg or 120 mg or 160 mg orally once daily dosing for 8 weeks

  • Venlafaxine hydrochloride sustained-release tabletsDrug

    75 mg or 150 mg or 225 mg orally once daily dosing for 8 weeks

Study groups in NCT06278038
Study groupRoleWhat they receive
Toludesvenlafaxine hydrochloride sustained-release tablets treatment groupExperimentalNot described
Receives: Drug: Toludesvenlafaxine hydrochloride sustained-release tablets
Venlafaxine hydrochloride sustained-release tablets treatment groupActive comparatorNot described
Receives: Drug: Venlafaxine hydrochloride sustained-release tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Snaith-Hamilton Pleasure Scale (SHAPS) Total Score

    The SHAPS is a well-validated 14-item self-report questionnaire commonly used to assess anhedonia. Each item on the SHAPS is worded so that higher scores indicate greater pleasure capacity. A total score can be derived by summing the responses to each item. Each item is rated as either 0 or 1, for a total score between 0 and 14, with higher scores corresponding to higher levels of anhedonia.

    Measured: Baseline and the end of week 8

Secondary outcomes (7)
  1. Snaith-Hamilton Pleasure Scale (SHAPS) Total Score

    The SHAPS is a well-validated 14-item self-report questionnaire commonly used to assess anhedonia. Each item on the SHAPS is worded so that higher scores indicate greater pleasure capacity. A total score can be derived by summing the responses to each item. Each item is rated as either 0 or 1, for a total score between 0 and 14, with higher scores corresponding to higher levels of anhedonia.

    Measured: Baseline, the end of Week 2 and 4

  2. Snaith-Hamilton Pleasure Scale (SHAPS) Reductive Rate

    Snaith-Hamilton Pleasure Scale (SHAPS) Reductive Rate(%) = (pre-treatment score - post-treatment score)/pre-treatment score ×100%. SHAPS Reductive Rate(%) ≥75% is recovery, 50% ~ 74% is significantly effective, 25% ~ 49% is effective, and < 25% is ineffective.

    Measured: The end of Week 2, 4 and 8

  3. Dimensional Anhedonia Rating Scale (DARS) Score

    DARS is a 17-item self-report questionnaire that is designed to assess anhedonia in major depressive disorder (MDD), and particularly to increase scale generalizability while maintaining specificity. Respondents provide their own examples of rewarding experiences across the domains of hobbies, social activities, food/drink, and sensory experience. Participants answer a set of standardized questions about desire, motivation, effort, and consummatory pleasure with a recall period of "right now" for the examples provided. The instrument is scored as a total sum of all items (range 0-68) with higher scores reflecting increased motivation, effort and pleasure (that is, less anhedonia).

    Measured: Baseline, the end of Week 2, 4 and 8

  4. Montgomery-Asberg Depression Rating Scale (MADRS) Score

    The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

    Measured: Baseline, the end of Week 2, 4 and 8

  5. 17-item Hamilton Depression Rating Scale (HAM-D17) Score

    HAM-D17 has been the gold standard for the assessment of depression. The score needs to be based on clinical interviews, and the time frame of the assessment is usually the situation in the previous week. Most items use a 5-point scale of 0 to 4. The standard of each level is: 0 indicates none, 1 indicates mild, 2 indicates moderate, 3 indicates severe, and 4 indicates extremely severe. A few items adopt the 3-level scoring method with 0~2 points, and the grading standard is: 0 indicates none, 1 indicates mild to moderate and 2 indicates severe.

    Measured: Baseline, the end of Week 2, 4 and 8

  6. Sheehan Disability Scale (SDS) Score

    SDS is composed of three self-rating dimensions, which assess functional status in work, social life/leisure activities, and family life/family responsibilities. Each dimension is scored on a scale of 0 to 10, with 1 to 3 indicating mild impairment, 4 to 6 indicating moderate impairment, 7 to 9 indicating significant impairment, and 10 indicating extreme severity. The three dimensions can also be added together to reflect the overall functional deficiency. The score ranges from 0 to 30, with 0 indicating no damage and 30 indicating significant damage.

    Measured: Baseline, the end of Week 2, 4 and 8

  7. Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Score

    Q-LES-Q-SF consists of 16 self-rated items. Each item is divided into five grades: 1 indicates very dissatisfied, 2 indicates dissatisfied, 3 indicates average, 4 indicates satisfied, and 5 indicates very satisfied. The higher the score, the better the happiness and quality of life satisfaction of the subjects. The first 14 items are used to generate an overall score, while the remaining 2 items are individual items that measure satisfaction and overall quality of life related to the study drug.

    Measured: Baseline, the end of Week 2, 4 and 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2024
  2. Study start22 Feb 2024
  3. Primary completion10 Nov 2024
  4. Study completion19 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06278038
Sponsor's protocol ID
RXL-RCT-02
Status last verified
Mar 2025
First submitted
29 Jan 2024
Last updated
1 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Toludesvenlafaxine hydrochloride sustained-release tablets and Venlafaxine hydrochloride sustained-release tablets in people with Major Depression Disorder, run by First Affiliated Hospital of Zhejiang University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Snaith-Hamilton Pleasure Scale (SHAPS) Total Score (time frame: Baseline and the end of week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.

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