Generalized Anxiety DisorderPhase 3BGFN-2022-01NCT06243614
Phase Ⅲ Clinical Trial of Buagafuran Capsules in the Treatment of GAD
A Phase 3 study testing Buagafuran capsules, 15mg/ capsule, Buspirone tablets, 5mg/ tablet and Buagafuran capsules mimic, 0mg/ capsule in people with Generalized Anxiety Disorder, run by Beijing Union Pharmaceutical Factory Ltd at 1 site in China.
Trial 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. 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?
- Buagafuran capsules, 15mg/ capsule, Buspirone tablets, 5mg/ tablet and Buagafuran capsules mimic, 0mg/ capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 410 participants
- Where
- 1 siteChina
- Study dates
- 24 Jul 2023to 30 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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;
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- 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;
- Receiving systemic psychotherapy or other non-pharmacological treatments (e.g., acupuncture, hypnosis, or phototherapy) within 6 weeks before the baseline visit;
- 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;
- Patients treated with monoamine oxidase inhibitors within -7 to 1 day before screening; Patients treated with fluoxetine within 30 days before screening;
- Patients using antipsychotics, antidepressants and mood stabilizers with less than 5 half-lives before the baseline washout period;
- Patients who discontinued traditional Chinese medicine, melatonin, and St. John's wort for less than 3 days before the baseline visit;
- In the experimental drug delivery within 7 days before and during the test, cannot fast grapefruit or grapefruit juice;
- 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;
- Unable to take medicine as prescribed;
- Participants enrolled in other clinical trials within 90 days before screening;
- Patients with other conditions deemed by the investigator to be ineligible for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Union Pharmaceutical Factory Ltd
Beijing, Beijing Municipality, 102600
Tao Sun, 13621169498, sunny.suntao@aliyun.com
About this study
Official title: Safety and Efficacy of Buagafuran Capsules in the Treatment of Generalized Anxiety Disorder: a Multi-center, Randomized, Double-blind, Double-dummy, Placebo-controlled, Positive-controlled, Flexible-dose Phase Ⅲ Clinical Trial
A placebo-controlled superiority design was used to evaluate the efficacy of 60-120 mg/ day of Buagafuran capsules in the treatment of GAD.
Read the detailed description
This was a multi-center, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled, flexible-dose phase III clinical trial of Buagafuran capsules. The stratification factor was the presence or absence of new generalized anxiety disorder (GAD) (new GAD vs. Non-new GAD).
Qualified subjects, according to the ratio of 2:2:1, were randomized into experimental group, placebo-control group and positive-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).
The dose of Buagafuran capsules/ Buagafuran capsules mimic can be adjusted from 60mg/ day to 120mg/ day according to treatment needs and tolerance in the follow-up period( at week 1, week 2, and week 4), and the dose of Buspirone tablets/ Buspirone tablets mimic can be adjusted from 10mg/ day to 20mg/ day at the same time.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Buagafuran capsules, 15mg/ capsule, Buspirone tablets, 5mg/ tablet, Buagafuran capsules mimic, 0mg/ capsule, Buspirone tablets mimic, 0mg/ tablet
- 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.
Buagafuran capsules, 15mg/ capsuleDrug
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;
Buspirone tablets, 5mg/ tabletDrug
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.
Buagafuran capsules mimic, 0mg/ capsuleDrug
Participants took Buagafuran capsules mimic daily. 2 to 4 capsules per time, twice per day, respectively, after breakfast and dinner for 8 weeks;
Buspirone tablets mimic, 0mg/ tabletDrug
Participants took Buspirone tablets mimic daily. 1 to 4 tablets per time, twice per day, respectively, after breakfast and dinner for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Drug: Buagafuran capsules mimic, 0mg/ capsule; Drug: Buspirone tablets mimic, 0mg/ tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: the end of week 8
Secondary outcomes (6)
Change in each factor score and item score of Hamilton anxiety scale
One of the secondary efficacy end point was the change from baseline to week 4 and 8 in each factor score and item score of Hamilton anxiety scale to determine the superiority of buagafuran capsules over placebo. The larger the difference between buagafuran capsules over placebo, the better the curative effect.
Measured: the end of week 4 and 8
Clinical global impression of improvement score
Subjective improvement of buagafuran capsules will be assessed using Clinical Global Impression of Improvement (CGI-I) score at week 4 and 8. The larger the difference between buagafuran capsules over placebo, the better the curative effect.
Measured: the end of week 4 and 8
Clinical global impression of severity score
Subjective severity of buagafuran capsules will be assessed by the change from baseline to week 4 and 8 with Clinical global impression of severity (CGI-S) score, to determine the superiority of buagafuran capsules over placebo. The larger the difference between buagafuran capsules over placebo, the better the curative effect.
Measured: the end of week 4 and 8
Complete remission rate
Complete remission rate was the proportion of subjects with HAMA total scale score ≤7 at the end of week 8. The larger the difference between buagafuran capsules over placebo, the better the curative effect.
Measured: the end of week 8
Response rate
Response rate was the proportion of subjects with HAMA total score decreased by ≥50% from baseline to week 8. The larger the difference between buagafuran capsules over placebo, the better the curative effect.
Measured: the end of week 8
Rapid-onset rate
Rapid-onset rate was the proportion of subjects with HAMA total score decreased by ≥20% from baseline to week 1 and 2. The larger the difference between buagafuran capsules over placebo, the better the curative effect.
Measured: the end of week 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start24 Jul 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
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.
- 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Union Pharmaceutical Factory Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- R&G Pharma Studies Co.,Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243614
- Sponsor's protocol ID
- BGFN-2022-01
- Other IDs
- 2022LB00288
- Acronym
- BGFN-2022-01
- Status last verified
- Jan 2024
- First submitted
- 7 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Buagafuran Capsules in the Treatment of Generalized Anxiety Disorder: a Multi-center, Randomized, Double-blind, Double-dummy, Placebo-controlled, Positive-controlled, Flexible-dose Phase Ⅲ Clinical Trial
- ClinicalTrials.gov ID
- NCT06243614
- Acronym / sponsor ID
- BGFN-2022-01 / BGFN-2022-01
- Conditions
- Generalized Anxiety Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- Beijing Union Pharmaceutical Factory LtdIndustry (pharma, biotech, devices)
- Collaborators
- R&G Pharma Studies Co.,Ltd.
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 6 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.
A placebo-controlled superiority design was used to evaluate the efficacy of 60-120 mg/ day of Buagafuran capsules in the treatment of GAD.
Detailed description
This was a multi-center, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled, flexible-dose phase III clinical trial of Buagafuran capsules. The stratification factor was the presence or absence of new generalized anxiety disorder (GAD) (new GAD vs. Non-new GAD).
Qualified subjects, according to the ratio of 2:2:1, were randomized into experimental group, placebo-control group and positive-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).
The dose of Buagafuran capsules/ Buagafuran capsules mimic can be adjusted from 60mg/ day to 120mg/ day according to treatment needs and tolerance in the follow-up period( at week 1, week 2, and week 4), and the dose of Buspirone tablets/ Buspirone tablets mimic can be adjusted from 10mg/ day to 20mg/ day at the same time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Buagafuran capsules, 15mg/ capsule, Drug: Buspirone tablets mimic, 0mg/ tabletParticipants 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). |
| Positive-control group | Active comparator | Drug: Buspirone tablets, 5mg/ tablet, Drug: Buagafuran capsules mimic, 0mg/ capsuleParticipants 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). |
| Placebo-control group | Placebo comparator | Drug: Buagafuran capsules mimic, 0mg/ capsule, Drug: Buspirone tablets mimic, 0mg/ tabletParticipants 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (25 listed)
- 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;
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 |
|---|---|---|
| Buagafuran capsules, 15mg/ capsuleParticipants 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; | Drug | Experimental group |
| Buspirone tablets, 5mg/ tabletParticipants 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. | Drug | Positive-control group |
| Buagafuran capsules mimic, 0mg/ capsuleParticipants took Buagafuran capsules mimic daily. 2 to 4 capsules per time, twice per day, respectively, after breakfast and dinner for 8 weeks; | Drug | Placebo-control group, Positive-control group |
| Buspirone tablets mimic, 0mg/ tabletParticipants took Buspirone tablets mimic daily. 1 to 4 tablets per time, twice per day, respectively, after breakfast and dinner for 8 weeks. | Drug | Experimental group, Placebo-control group |
Primary outcome
Change in Hamilton anxiety scale score after treatment
Time frame: the end of week 8
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.
6 secondary outcomes
Change in each factor score and item score of Hamilton anxiety scale
Time frame: the end of week 4 and 8
Clinical global impression of improvement score
Time frame: the end of week 4 and 8
Clinical global impression of severity score
Time frame: the end of week 4 and 8
Complete remission rate
Time frame: the end of week 8
Response rate
Time frame: the end of week 8
Rapid-onset rate
Time frame: the end of week 1 and 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
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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.
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 Buagafuran capsules, 15mg/ capsule, Buspirone tablets, 5mg/ tablet and Buagafuran capsules mimic, 0mg/ capsule in people with Generalized Anxiety Disorder, run by Beijing Union Pharmaceutical Factory 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 25 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: looking for participants now, as of the sponsor's last update on 6 Feb 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tao Sun (13621169498, sunny.suntao@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton anxiety scale score after treatment (time frame: 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 6 Feb 2024.