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.
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);
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- 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
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.
- Conditions
- Major Depression Disorder
- 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 group | Role | What they receive |
|---|---|---|
| Toludesvenlafaxine hydrochloride sustained-release tablets treatment group | Experimental | Not described Receives: Drug: Toludesvenlafaxine hydrochloride sustained-release tablets |
| Venlafaxine hydrochloride sustained-release tablets treatment group | Active comparator | Not 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.
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)
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
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
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
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
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
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
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.
- First posted26 Feb 2024
- Study start22 Feb 2024
- Primary completion10 Nov 2024
- Study completion19 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depression DisorderStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06278038
- Acronym / sponsor ID
- RXL-RCT-02
- Conditions
- Major Depression Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 10 Nov 2024 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toludesvenlafaxine hydrochloride sustained-release tablets treatment group | Experimental | Drug: Toludesvenlafaxine hydrochloride sustained-release tablets |
| Venlafaxine hydrochloride sustained-release tablets treatment group | Active comparator | Drug: Venlafaxine hydrochloride sustained-release tablets |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toludesvenlafaxine hydrochloride sustained-release tablets80 mg or 120 mg or 160 mg orally once daily dosing for 8 weeks | Drug | Toludesvenlafaxine hydrochloride sustained-release tablets treatment group |
| Venlafaxine hydrochloride sustained-release tablets75 mg or 150 mg or 225 mg orally once daily dosing for 8 weeks | Drug | Venlafaxine hydrochloride sustained-release tablets treatment group |
Primary outcome
Snaith-Hamilton Pleasure Scale (SHAPS) Total Score
Time frame: Baseline and the end of week 8
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.
7 secondary outcomes
Snaith-Hamilton Pleasure Scale (SHAPS) Total Score
Time frame: Baseline, the end of Week 2 and 4
Snaith-Hamilton Pleasure Scale (SHAPS) Reductive Rate
Time frame: The end of Week 2, 4 and 8
Dimensional Anhedonia Rating Scale (DARS) Score
Time frame: Baseline, the end of Week 2, 4 and 8
Montgomery-Asberg Depression Rating Scale (MADRS) Score
Time frame: Baseline, the end of Week 2, 4 and 8
17-item Hamilton Depression Rating Scale (HAM-D17) Score
Time frame: Baseline, the end of Week 2, 4 and 8
Sheehan Disability Scale (SDS) Score
Time frame: Baseline, the end of Week 2, 4 and 8
Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Score
Time frame: Baseline, the end of Week 2, 4 and 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.