Generalized Anxiety DisorderPhase 3NCT05970510
A Study to Evaluate Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in Generalized Anxiety Disorder.
A Phase 3 study testing Toludesvenlafaxine Hydrochloride Sustained-release Tablet 80mg and Toludesvenlafaxine Hydrochloride Sustained-release Tablet 160mg in people with Generalized Anxiety Disorder, run by Luye Pharma Group Ltd. at 1 site in China.
Trial summary
The study aims to evaluate the efficacy and safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets compared to placebo in adults participants with generalized anxiety disorder over a period of 8 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Toludesvenlafaxine Hydrochloride Sustained-release Tablet 80mg and Toludesvenlafaxine Hydrochloride Sustained-release Tablet 160mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 555 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2023to 31 Jul 2025
- Phase
- Phase 3
- 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
- Male or female aged 18 to 65 years subjects;
- Meet the Diagnostic and Statistical Manual of Manual Disorders, fifth Edition(DSM-5) criteria for Generalized Anxiety Disorder;
- Have a Hamilton Anxiety(HAMA) Rating Scale total score ≥21 points at screening and baseline;
- Have a Hamilton Anxiety(HAMA) Rating Scale score ≥2 points on both item 1(anxious mood) and item 2(tension) at screening and baseline;
- Have a clinical Global Impression -severity illness (CGI-S) score≥4 points at screening and baseline.
Who cannot join
- Meet the diagnostic criteria for other psychotic disorders(defined by DSM-5, except for GAD), including major depression disorder within 6 months prior to screening , presence or history of Schizophrenia Spectrum and Other Psychotic Disorders, Bipolar and Related Disorders, Obsessive-Compulsive and related Disorders, post-traumatic stress disorder, anorexia nervosa or bulimia and personality disorder;
- Meet the diagnostic criteria for substance or alcohol abuse (defined by DSM-5, except for nicotine or caffeine) within 6 months prior to screening;
- Have anxious symtoms secondary to other physical illnesses or mental illnesses and anxious induced by psychoactive substance;
- Withdrawal psychotropic drugs within 5 half-lives (at least 2 weeks for monoamine oxidase inhibitors, at least 1 month for fluoxetine, and at least 2 weeks for benzodiazepines or barbiturates) prior to randomization;
- Have received psychosurgery or physical therapy for psychiatric illness (such as transcranial magnetic stimulation) within 3 months prior to screening;
- Have received systematic psychotherapy or other non-drug therapies for psychiatric disorders (such as acupuncture or light therapy) within 6 weeks prior to screening;
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- Concomitant with serious and unstable illness, including cardiovascular, hepatic, renal, hematological, endocrine illness, malignant tumors and other physical illness;
- Have a history of seizures (except for seizures caused by febrile convulsions in childhood);
- Have a history of gastrointestinal disease or surgery known to interfere with investigation product absorption or excretion;
- Known or suspected allergic or severe reaction to investigation product or inactive ingredients; or allergic to venlafaxine or desvenlafaxine; or allergic constitution (defined as allergic to two or more drugs or food) and unfit to participate judged by investigator;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ⅲ Study to Evaluate the Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in Participants With Generalized Anxiety Disorder.
The study aims to evaluate the efficacy and safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets compared to placebo in adults participants with generalized anxiety disorder over a period of 8 weeks.
Read the detailed description
The study consists of two periods: screening period (2 weeks) and double-blind treatment period (8 weeks). After the screening period, generalized anxiety disorder patients who satisfies the inclusion criteria are randomly assigned in the 1:1:1 ratio to receive either placebo or Toludesvenlafaxine Hydrochloride Sustained-release Tablets at two dose levels (80 ,160 mg/day) for 8 weeks. Participants are evaluated at screening, baseline visits and double-blind period.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Toludesvenlafaxine Hydrochloride Sustained-release Tablet 80mg, Toludesvenlafaxine Hydrochloride Sustained-release Tablet 160mg, placebo
- Keywords
- Toludesvenlafaxine Hydrochloride Sustained-release Tablet, generalized anxiety disorder, efficacy, safety
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toludesvenlafaxine Hydrochloride Sustained-release Tablet 80mgDrug
orally once a day
Toludesvenlafaxine Hydrochloride Sustained-release Tablet 160mgDrug
orally once a day
placeboDrug
orally once a day
| Study group | Role | What they receive |
|---|---|---|
| Toludesvenlafaxine Hydrochloride Sustained-release Tablets 80 mg group | Experimental | orally once a day Receives: Drug: Toludesvenlafaxine Hydrochloride Sustained-release Tablet 80mg |
| Toludesvenlafaxine Hydrochloride Sustained-release Tablets 160 mg group | Experimental | orally once a day Receives: Drug: Toludesvenlafaxine Hydrochloride Sustained-release Tablet 160mg |
| Placebo | Sham comparator | orally once a day Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale total score at endpoint
The HAMA Scale consist of 14 items that include psychic, somatic, and behavioral symptoms associated with anxiety. Each items is rated on a 5-point scale of 0(not present) to 4(very severe) so that scores may range from 0 to 56, with high scores indicating greater illness severity.
Measured: from baseline to week 8
Secondary outcomes (12)
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale psychic factor score (Items 1~6 and Item 14) at endpoint
The psychic factor score is the sum of items 1-6 and items 14(including items such as anxious mood, tension, fear, insomnia, and behavioral symptoms).Each items is rated on a 5-point scale of 0(not present) to 4(very severe) so that scores may range from 0 to 28, with high scores indicating greater illness severity.
Measured: from baseline to week 8
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale somatic factor score (Items 7~13) at endpoint
The somatic factor score is the sum of items 7-13(including items such as cardiovascular, respiratory, and gastrointestinal symptoms).Each items is rated on a 5-point scale of 0(not present) to 4(very severe) so that scores may range from 0 to 28, with high scores indicating greater illness severity.
Measured: from baseline to week 8
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale item 1（Anxious mood）Score at endpoint
The item is rated on a 5-point scale of 0(not present) to 4(very severe) so that score may range from 0 to 4, with high scores indicating greater illness severity.
Measured: from baseline to week 8
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale item 2（Tension）Score at endpoint
The item is rated on a 5-point scale of 0(not present) to 4(very severe) so that score may range from 0 to 4, with high scores indicating greater illness severity.
Measured: from baseline to week 8
Percentage of participants with response at endpoint
Response was defined as a≥50% reduction from baseline to endpoint in the HAMA total score.
Measured: from baseline to week 8
Percentage of participants with remission at endpoint
Remission was defined as a HAMA total score ≤7 points at endpoint
Measured: from baseline to week 8
Clinical Global Impression Scale - improvement (CGI-I) score at endpoint
The CGI-I scale measures the participant's improvement (or worsening) as assessed by the investigator relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Measured: from baseline to week 8
Change from baseline in Clinical Global Impression Scale - severity (CGI-S) score at endpoint
The CGI-S scale is a 7-point scale to rate the severity of the patient's illness. Patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Measured: from baseline to week 8
Change from baseline in the Sheehan Disability Scale(SDS) score at endpoint
The SDS scale consists of 3 items evaluating impairment in work/school， social life/leisure activities, and family life/home responsibilities. Each item is scored on a scale of 0(unimpaired) to 10(highly impaired).
Measured: from baseline to week 8
Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) score at endpoint
The scale consists of 3 items evaluating impairment in work/school， social life/leisure activities, and family life/home responsibilities. Each item is scored on a scale of 0(unimpaired) to 10(highly impaired).
Measured: from baseline to week 8
Incidence and severity of adverse effects (AEs)
Measured: from baseline to week 8
Change from baseline in the Columbia Suicide severity Rating Scale (C-SSRS) score at endpoint
The C-SSRS captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a "yes" answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a "yes" answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.
Measured: from baseline to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start4 Aug 2023
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Luye Pharma Group Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 555 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhang Hongyan, Principal investigator, Peking University Sixth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970510
- Sponsor's protocol ID
- LY03005/CT-CHN-307
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2023
- Last updated
- 8 Jul 2026
- 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 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ⅲ Study to Evaluate the Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in Participants With Generalized Anxiety Disorder.
- ClinicalTrials.gov ID
- NCT05970510
- Acronym / sponsor ID
- LY03005/CT-CHN-307
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Toludesvenlafaxine Hydrochloride Sustained-release Tablet, generalized anxiety disorder, efficacy, safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 555 participants (actual)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 1 Aug 2023 (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 study aims to evaluate the efficacy and safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets compared to placebo in adults participants with generalized anxiety disorder over a period of 8 weeks.
Detailed description
The study consists of two periods: screening period (2 weeks) and double-blind treatment period (8 weeks). After the screening period, generalized anxiety disorder patients who satisfies the inclusion criteria are randomly assigned in the 1:1:1 ratio to receive either placebo or Toludesvenlafaxine Hydrochloride Sustained-release Tablets at two dose levels (80 ,160 mg/day) for 8 weeks. Participants are evaluated at screening, baseline visits and double-blind period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Toludesvenlafaxine Hydrochloride Sustained-release Tablets 80 mg group | Experimental | Drug: Toludesvenlafaxine Hydrochloride Sustained-release Tablet 80mgorally once a day |
| Toludesvenlafaxine Hydrochloride Sustained-release Tablets 160 mg group | Experimental | Drug: Toludesvenlafaxine Hydrochloride Sustained-release Tablet 160mgorally once a day |
| Placebo | Sham comparator | Drug: placeboorally once a day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged 18 to 65 years subjects;
- Meet the Diagnostic and Statistical Manual of Manual Disorders, fifth Edition(DSM-5) criteria for Generalized Anxiety Disorder;
- Have a Hamilton Anxiety(HAMA) Rating Scale total score ≥21 points at screening and baseline;
- Have a Hamilton Anxiety(HAMA) Rating Scale score ≥2 points on both item 1(anxious mood) and item 2(tension) at screening and baseline;
- Have a clinical Global Impression -severity illness (CGI-S) score≥4 points at screening and baseline.
Key exclusion criteria (10 listed)
- Meet the diagnostic criteria for other psychotic disorders(defined by DSM-5, except for GAD), including major depression disorder within 6 months prior to screening , presence or history of Schizophrenia Spectrum and Other Psychotic Disorders, Bipolar and Related Disorders, Obsessive-Compulsive and related Disorders, post-traumatic stress disorder, anorexia nervosa or bulimia and personality disorder;
- Meet the diagnostic criteria for substance or alcohol abuse (defined by DSM-5, except for nicotine or caffeine) within 6 months prior to screening;
- Have anxious symtoms secondary to other physical illnesses or mental illnesses and anxious induced by psychoactive substance;
- Withdrawal psychotropic drugs within 5 half-lives (at least 2 weeks for monoamine oxidase inhibitors, at least 1 month for fluoxetine, and at least 2 weeks for benzodiazepines or barbiturates) prior to randomization;
- Have received psychosurgery or physical therapy for psychiatric illness (such as transcranial magnetic stimulation) within 3 months prior to screening;
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 Tablet 80mgorally once a day | Drug | Toludesvenlafaxine Hydrochloride Sustained-release Tablets 80 mg group |
| Toludesvenlafaxine Hydrochloride Sustained-release Tablet 160mgorally once a day | Drug | Toludesvenlafaxine Hydrochloride Sustained-release Tablets 160 mg group |
| placeboorally once a day | Drug | Placebo |
Primary outcome
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale total score at endpoint
Time frame: from baseline to week 8
The HAMA Scale consist of 14 items that include psychic, somatic, and behavioral symptoms associated with anxiety. Each items is rated on a 5-point scale of 0(not present) to 4(very severe) so that scores may range from 0 to 56, with high scores indicating greater illness severity.
12 secondary outcomes
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale psychic factor score (Items 1~6 and Item 14) at endpoint
Time frame: from baseline to week 8
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale somatic factor score (Items 7~13) at endpoint
Time frame: from baseline to week 8
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale item 1（Anxious mood）Score at endpoint
Time frame: from baseline to week 8
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale item 2（Tension）Score at endpoint
Time frame: from baseline to week 8
Percentage of participants with response at endpoint
Time frame: from baseline to week 8
Percentage of participants with remission at endpoint
Time frame: from baseline to week 8
Clinical Global Impression Scale - improvement (CGI-I) score at endpoint
Time frame: from baseline to week 8
Change from baseline in Clinical Global Impression Scale - severity (CGI-S) score at endpoint
Time frame: from baseline to week 8
Change from baseline in the Sheehan Disability Scale(SDS) score at endpoint
Time frame: from baseline to week 8
Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) score at endpoint
Time frame: from baseline to week 8
Incidence and severity of adverse effects (AEs)
Time frame: from baseline to week 8
Change from baseline in the Columbia Suicide severity Rating Scale (C-SSRS) score at endpoint
Time frame: from baseline to week 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 8 Jul 2026.
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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.
Zhang Hongyan principal investigator
Peking University Sixth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Toludesvenlafaxine Hydrochloride Sustained-release Tablet 80mg and Toludesvenlafaxine Hydrochloride Sustained-release Tablet 160mg in people with Generalized Anxiety Disorder, run by Luye Pharma Group Ltd. 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 10 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 8 Jul 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale total score at endpoint (time frame: from baseline to 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 8 Jul 2026.