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

NCT06243614 | Recruiting Phase 3

• 2 other identifiers: BGFN-2022-012022LB00288
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Hamilton anxiety scale score after treatment

  The Hamilton Anxiety (HAMA) Scale total score reflects the severity of the patients anxiety symptoms. The primary efficacy end point was the change from baseline to week 8 in HAMA total score to determine the superiority of buagafuran capsules over placebo. The larger the difference between buagafuran capsules over placebo, the better the curative effect.

  the end of week 8

Secondary Outcomes (6)

• Change in each factor score and item score of Hamilton anxiety scale

  the end of week 4 and 8

• Clinical global impression of improvement score

  the end of week 4 and 8

• Clinical global impression of severity score

  the end of week 4 and 8

• Complete remission rate

  the end of week 8

• Response rate

  the end of week 8

Study Arms (3)

Experimental group

EXPERIMENTAL

Participants took 60-120 mg/day Buagafuran capsules and Buspirone tablets mimic; 2 times per day, after breakfast and dinner, consecutively for 8 weeks; The dose can be adjusted according to treatment needs and tolerance in the follow-up period( at week 1, week 2 and week 4).

Drug: Buagafuran capsules, 15mg/ capsule; Drug: Buspirone tablets mimic, 0mg/ tablet

Positive-control group

ACTIVE COMPARATOR

Participants took 10-20mg/day Buspirone tablets and Buagafuran capsules mimic; 2 times per day, after breakfast and dinner, consecutively for 8 weeks; The dose can be adjusted according to treatment needs and tolerance in the follow-up period( at week 1, week 2 and week 4).

Drug: Buspirone tablets, 5mg/ tablet; Drug: Buagafuran capsules mimic, 0mg/ capsule

Placebo-control group

PLACEBO COMPARATOR

Participants took Buagafuran capsules mimic and Buspirone tablets mimic; 2 times per day, after breakfast and dinner, consecutively for 8 weeks; The dose can be adjusted according to treatment needs and tolerance in the follow-up period( at week 1, week 2 and week 4).

Drug: Buagafuran capsules mimic, 0mg/ capsule; Drug: Buspirone tablets mimic, 0mg/ tablet

Interventions

Buagafuran capsules, 15mg/ capsule DRUG

Participants took 60-120 mg Buagafuran capsules daily. The initial dose was 60mg/ day, 2 to 4 capsules per time, twice per day, respectively, after breakfast and dinner for 8 weeks;

Experimental group

Buspirone tablets, 5mg/ tablet DRUG

Participants took 10-20mg Buspirone tablets daily. The initial dose was 10mg/ day, 1 to 4 tablets per time, twice per day, respectively, after breakfast and dinner for 8 weeks.

Positive-control group

Buagafuran capsules mimic, 0mg/ capsule DRUG

Participants took Buagafuran capsules mimic daily. 2 to 4 capsules per time, twice per day, respectively, after breakfast and dinner for 8 weeks;

Placebo-control group; Positive-control group

Buspirone tablets mimic, 0mg/ tablet DRUG

Participants took Buspirone tablets mimic daily. 1 to 4 tablets per time, twice per day, respectively, after breakfast and dinner for 8 weeks.

Experimental group; Placebo-control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients aged 18-65 years old, of both sexes;
• 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.);
• The patient requires psychiatric medication;
• 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;
• Able to understand and voluntarily participate in this trial, signed informed consent.

You may not qualify if:

• Patients with serious suicide risk at present, or HAMD-17 item 3-suicide score ≥3;
• Patients with HAMD-17 \> 17;
• Patients whose HAMA scores decreased by ≥20% in the baseline period compared with the screening period:
• Those who met the DSM-5 diagnostic criteria for other mental disorders except GAD;
• 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;
• Alcohol or drug abuse or dependence within 180 days before screening;
• 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;
• 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);
• Patients with a history of epilepsy or any other disease that may induce seizures, except convulsions caused by febrile convulsions in children;
• 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);
• 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;
• Patients who had undergone psychiatric surgery, electroconvulsive therapy or transcranial magnetic stimulation within 90 days before screening;
• Patients treated with β-blockers within 90 days before screening；
• Patients with severe hypersensitivity, or allergic to at least 2 kinds of drugs (including photosensitivity);
• 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;

Sponsors & Collaborators

• Beijing Union Pharmaceutical Factory Ltd: lead
• R&G Pharma Studies Co.,Ltd.: collaborator

Study Sites (1)

Beijing Union Pharmaceutical Factory Ltd

Beijing, Beijing Municipality, 102600, China

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

buagafuran; Buspirone; Tablets; tebufenozide

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Tao Sun

CONTACT

13621169498; sunny.suntao@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2024
• First Posted: February 6, 2024
• Study Start: July 24, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 6, 2024

Record last verified: 2024-01

Locations

CN (1)