Evaluating a new medication for generalized anxiety disorder
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.
This study is testing a new medication for anxiety to see if it helps adults with generalized anxiety disorder feel better compared to a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 555 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Luye Pharma Group Ltd. Industry-sponsored |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05970510 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in adults diagnosed with generalized anxiety disorder. Participants will undergo a screening period followed by an 8-week double-blind treatment phase, where they will be randomly assigned to receive either the medication at two different doses or a placebo. The study aims to assess changes in anxiety levels using standardized rating scales throughout the treatment period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who meet the DSM-5 criteria for generalized anxiety disorder and have a significant level of anxiety as measured by specific rating scales.
Not a fit: Patients with other psychotic disorders or those who have had major depression within the last six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from generalized anxiety disorder.
How similar studies have performed: Other studies have shown promise in treating generalized anxiety disorder with similar pharmacological approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female aged 18 to 65 years subjects; 2. Meet the Diagnostic and Statistical Manual of Manual Disorders, fifth Edition(DSM-5) criteria for Generalized Anxiety Disorder; 3. Have a Hamilton Anxiety(HAMA) Rating Scale total score ≥21 points at screening and baseline; 4. Have a Hamilton Anxiety(HAMA) Rating Scale score ≥2 points on both item 1(anxious mood) and item 2(tension) at screening and baseline; 5. Have a clinical Global Impression -severity illness (CGI-S) score≥4 points at screening and baseline. Exclusion Criteria: 1. 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; 2. Meet the diagnostic criteria for substance or alcohol abuse (defined by DSM-5, except for nicotine or caffeine) within 6 months prior to screening; 3. Have anxious symtoms secondary to other physical illnesses or mental illnesses and anxious induced by psychoactive substance; 4. 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; 5. Have received psychosurgery or physical therapy for psychiatric illness (such as transcranial magnetic stimulation) within 3 months prior to screening; 6. Have received systematic psychotherapy or other non-drug therapies for psychiatric disorders (such as acupuncture or light therapy) within 6 weeks prior to screening; 7. Concomitant with serious and unstable illness, including cardiovascular, hepatic, renal, hematological, endocrine illness, malignant tumors and other physical illness; 8. Have a history of seizures (except for seizures caused by febrile convulsions in childhood); 9. Have a history of gastrointestinal disease or surgery known to interfere with investigation product absorption or excretion; 10. 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;
Where this trial is running
Beijing
- Peking University Sixth Hospital — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Zhang Hongyan — Peking University Sixth Hospital
- Study coordinator: Zhang Hongyan
- Email: hongyanzhang@bjmu.edu.cn
- Phone: 13601237138
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.