Phase 3 Clinical Trial of Buagafuran Capsules in the Treatment of GAD

NCT ID: NCT06243640

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 504 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-25
• Study Completion Date: 2027-06-30

Brief Summary

A placebo-controlled superiority design was used to evaluate the efficacy of 60 mg/ day or 120 mg/ day of Buagafuran capsules in the treatment of GAD

Detailed Description

This was a multi-center, randomized, double-blind, placebo-controlled, fixed-dose phase III clinical trial. Hierarchical factors for whether new generalized anxiety disorder (GAD) (new GAD vs. Non-new GAD).

Qualified subjects, according to the ratio of 1:1:1, were randomized into high-dose group, low-dose group and placebo-control group, and received a treatment course of 8 weeks. Participants were followed from baseline outpatient visit until end of the follow-up period( 10 weeks and 7 visits in total).

Conditions

Generalized Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

High-dose experimental group

Subjects took 120mg per day of Buagafuran capsules after breakfast and dinner for 8 weeks

Group Type: EXPERIMENTAL

Buagafuran capsules, 15mg/ capsule

Intervention Type: DRUG

Subjects took Buagafuran capsules; twice per day, respectively, after breakfast and dinner for 8 weeks;

Low-dose experimental group

Subjects took 60mg per day of Buagafuran capsules and Buagafuran capsules mimic after breakfast and dinner for 8 weeks

Group Type: EXPERIMENTAL

Buagafuran capsules, 15mg/ capsule

Intervention Type: DRUG

Subjects took Buagafuran capsules; twice per day, respectively, after breakfast and dinner for 8 weeks;

Buagafuran capsules mimic, 0mg/ capsule

Intervention Type: DRUG

Subjects took Buagafuran capsules mimic. twice per day, respectively, after breakfast and dinner for 8 weeks;

Placebo-Control group

Subjects took 0 mg per day Buagafuran capsules mimic after breakfast and dinner for 8 weeks

Group Type: PLACEBO_COMPARATOR

Buagafuran capsules mimic, 0mg/ capsule

Intervention Type: DRUG

Subjects took Buagafuran capsules mimic. twice per day, respectively, after breakfast and dinner for 8 weeks;

Interventions

Buagafuran capsules, 15mg/ capsule

Subjects took Buagafuran capsules; twice per day, respectively, after breakfast and dinner for 8 weeks;

Intervention Type: DRUG

Buagafuran capsules mimic, 0mg/ capsule

Subjects took Buagafuran capsules mimic. twice per day, respectively, after breakfast and dinner for 8 weeks;

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Outpatients aged 18-65 years old, of both sexes;

2. Met the diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for generalized anxiety disorder (GAD) and confirmed by the Brief International Neuropsychiatric Interview (M.I.N.I.);

3. The patient requires psychiatric medication;

4. Hamilton Anxiety Scale (HAMA) score ≥20, Hamilton Depression Scale (HAMD-17) score ≤2, Clinical Global Impression Scale (CGI-S) score ≥4 at screening and baseline Points;

5. Able to understand and voluntarily participate in this trial, signed informed consent.

Exclusion Criteria

1. Patients with serious suicide risk at present, or HAMD-17 item 3-suicide score ≥3;

2. Patients with HAMD-17 > 17;

3. Patients whose HAMA scores decreased by ≥20% in the baseline period compared with the screening period:

4. Those who met the DSM-5 diagnostic criteria for other mental disorders except GAD;

5. Patients with previous history of depression, obsessive-compulsive disorder, bipolar disorder, psychotic disorder, factitious disorder and somatoform disorder; There were severe personality disorders, especially antisocial, borderline, or histrionic personality disorder, which were judged by the investigator to affect the patient's adherence to the study protocol;

6. Alcohol or drug abuse or dependence within 180 days before screening;

7. With severe or unstable has clinical significance of somatic disease, including any cardiovascular, cancer, kidney, respiratory, endocrine (including abnormal thyroid function), digestion, blood (such as with bleeding tendency) or nervous system diseases;

8. Patients whose physical examination or vital signs were abnormal and clinically significant (e.g. inadequately controlled hypertension, systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg);

9. Patients with a history of epilepsy or any other disease that may induce seizures, except convulsions caused by febrile convulsions in children;

10. Important abnormalities in laboratory tests during the screening period, such as abnormal liver function tests (alanine aminotransferase or aspartate transaminase > 2 times the normal value); Renal insufficiency (blood urea nitrogen or creatinine > 1.2 times the upper limit of normal);

11. Clinically significant abnormalities on electrocardiography (QT interval corrected by Fridericia method: ≥450 ms for men or ≥470 ms for women) or conditions deemed ineligible by the investigators;

12. Patients who had undergone psychiatric surgery, electroconvulsive therapy or transcranial magnetic stimulation within 90 days before screening;

13. Patients treated with β-blockers within 90 days before screening；

14. Patients with severe hypersensitivity, or allergic to at least 2 kinds of drugs (including photosensitivity);

15. Patients who had previously used two or more antidepressants and/or benzodiazepines at a clinically appropriate dose for at least 4 weeks but were still ineffective;

16. Receiving systemic psychotherapy or other non-pharmacological treatments (e.g., acupuncture, hypnosis, or phototherapy) within 6 weeks before the baseline visit;

17. Those who had used benzodiazepines within -7 to -1 days before screening, such as lorazepam, oxazepam, and alprazolam for less than 5 half-lives; The use of benzodiazepines with longer half-lives, such as diazepam, clonazepam, nitrazepam, estazolam, and flurazepam, not more than 5 half-lives or less than 30 days from the screening period, or the use of barbiturates not more than 5 half-lives or less than 30 days from the screening period;

18. Patients treated with monoamine oxidase inhibitors within -7 to 1 day before screening; Patients treated with fluoxetine within 30 days before screening;

19. Patients using antipsychotics, antidepressants and mood stabilizers with less than 5 half-lives before the baseline washout period;

20. Patients who discontinued traditional Chinese medicine, melatonin, and St. John's wort for less than 3 days before the baseline visit;

21. In the experimental drug delivery within 7 days before and during the test, cannot fast grapefruit or grapefruit juice;

22. Women during pregnancy or lactation experiments have fertility requirement (including men), and not to the male, the female patients is safe and effective contraceptive measures;

23. Unable to take medicine as prescribed;

24. Participants enrolled in other clinical trials within 90 days before screening;

25. Patients with other conditions deemed by the investigator to be ineligible for enrollment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

R&G Pharma Studies Co.,Ltd.

INDUSTRY

Sponsor Role: collaborator

Beijing Union Pharmaceutical Factory Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Union Pharmaceutical Factory Ltd

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Tao Sun

Role: CONTACT

sunny.suntao@aliyun.com

13621169498

Facility Contacts

Tao Sun

Role: primary

sunny.suntao@aliyun.com

13621169498

Other Identifiers

2022LB00288

Identifier Type: REGISTRY

Identifier Source: secondary_id

BGFN-2022-02

Identifier Type: -

Identifier Source: org_study_id