BridgeMD
New treatment option for Generalized Anxiety Disorder
Official title Prospective Clinical Trial of Crisugabalin Capsules in the Treatment of Generalized Anxiety Disorder
ClinicalTrials.gov ID: NCT07330648
What this study is testing
What is Crisugabalin 20mg bid?
Crisugabalin 20mg bid is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for generalized anxiety disorder.
Also referred to as HSK16149.
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 40 mg/ day of Crisugabalin capsules in the treatment of GAD.
- Phase 2: a mid-size study of how well it works
- 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 and older
You may be able to join if
- Able to understand and voluntarily participate in the trial, and provide written informed consent form (ICF);
- Male or female aged ≥18 years (inclusive of the threshold value);
- Met the diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for generalized anxiety disorder (GAD) and confirmed by...
- Require pharmacological treatment for psychiatric symptoms;
- Hamilton Anxiety Scale (HAMA) score ≥20, Hamilton Depression Scale (HAMD-17) score ≤2, Clinical Global Impression Scale (CGI-S) score ≥4 at screening...
You likely can't join if
- people with serious suicide risk at present, or HAMD-17 item 3-suicide score ≥3;
- people with HAMD-17 \> 17;
- people 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;
- people 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
- Able to understand and voluntarily participate in the trial, and provide written informed consent form (ICF);
- Male or female aged ≥18 years (inclusive of the threshold value);
- 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.);
- Require pharmacological treatment for psychiatric symptoms;
- 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;
- people with serious suicide risk at present, or HAMD-17 item 3-suicide score ≥3;
- people with HAMD-17 \> 17;
- people 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;
- people 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...
- History of inadequate response to at least two prior antidepressant drugs and/or benzodiazepines after adequate dose and duration of treatment (i.e., at least 4 weeks at a clinically appropriate dose), or failure to...
- History of severe hypersensitivity reactions (e.g., anaphylaxis) or allergies to at least two classes of drugs (including photosensitivity), or known hypersensitivity to pregabalin, the investigational drug...
- people 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);
- people with a history of epilepsy or any other disease that may induce seizures, except convulsions caused by febrile convulsions in children;
- Severe hematologic, hepatic or renal dysfunction during the screening period, the subject will be excluded if: a. Neutrophils \ 2.5 × upper limit of normal (ULN), or TBIL \> 1.5 × ULN; c. Estimation of glomerular...
- 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;
- people who had undergone psychiatric surgery, electroconvulsive therapy or transcranial magnetic stimulation within 90 days before screening;
- Use of β-blockers within 90 days prior to screening with an ongoing need for continued treatment;
- Receiving systemic psychotherapy or other non-pharmacological treatments (e.g., acupuncture, hypnosis, or phototherapy) within 6 weeks before the baseline visit;
- people with dysphagia or inability to tolerate oral medications.
- people with active gastrointestinal disorders (including any history of gastrointestinal surgery) that, in the investigator's judgment, may interfere with the absorption of the investigational drug.
- 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 who discontinued traditional Chinese medicine, melatonin, and St. John's wort for less than 3 days before the baseline visit;
- Pregnant or preparing for pregnancy or breastfeeding during the study period, or people were not willing to use reliable contraceptives methods from the date of ICF signature until 28 days after the last trial drug...
- Individuals engaged in potentially hazardous mechanical operations such as working at heights or operating motor vehicles.
- Participants enrolled in other clinical trials within 30 days before screening;
- people 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
- Hefei, Anhui, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, 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.