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New treatment option for Generalized Anxiety Disorder
Official title Phase Ⅲ Clinical Trial of Buagafuran Capsules in the Treatment of GAD
ClinicalTrials.gov ID: NCT06243614
What this study is testing
What is Buagafuran capsules, 15mg/ capsule?
Buagafuran capsules, 15mg/ capsule is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for generalized anxiety disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A placebo-controlled superiority design was used to evaluate the efficacy of 60-120 mg/ day of Buagafuran capsules in the treatment of GAD.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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 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...
- Able to understand and voluntarily participate in this trial, signed informed consent.
You likely can't join 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...
- Alcohol or drug abuse or dependence within 180 days before screening;
See the full eligibility criteria
- 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.
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.