Actively Recruiting
Prospective Clinical Trial of Crisugabalin Capsules in the Treatment of Generalized Anxiety Disorder
Led by Anhui Medical University · Updated on 2026-01-09
216
Participants Needed
1
Research Sites
72 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A placebo-controlled superiority design was used to evaluate the efficacy of 40 mg/ day of Crisugabalin capsules in the treatment of GAD.
CONDITIONS
Official Title
Prospective Clinical Trial of Crisugabalin Capsules in the Treatment of Generalized Anxiety Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily participate in the trial, providing written informed consent
- Male or female aged 18 years or older
- Diagnosed with generalized anxiety disorder (GAD) according to DSM-5 and confirmed by the Brief International Neuropsychiatric Interview
- Require pharmacological treatment for psychiatric symptoms
- Hamilton Anxiety Scale (HAMA) score of 20 or higher, Hamilton Depression Scale (HAMD-17) score of 2 or less, Clinical Global Impression Scale (CGI-S) score of 4 or higher at screening and baseline
You will not qualify if you...
- Current serious suicide risk or HAMD-17 item 3-suicide score of 3 or higher
- HAMD-17 total score greater than 17
- Decrease of 20% or more in HAMA scores between screening and baseline
- Diagnosis of mental disorders other than GAD
- History of depression, obsessive-compulsive disorder, bipolar disorder, psychotic disorder, factitious disorder, somatoform disorder, or severe personality disorders affecting study adherence
- Alcohol or drug abuse within 180 days before screening
- Severe or unstable significant somatic diseases including cardiovascular, cancer, kidney, respiratory, endocrine, digestive, blood, or nervous system diseases
- History of inadequate response to at least two prior antidepressants and/or benzodiazepines or insufficient response to pregabalin 300 mg/day
- History of severe allergic reactions or hypersensitivity to pregabalin or related compounds
- Clinically significant abnormal physical exam or vital signs including uncontrolled hypertension
- History of epilepsy or seizure-inducing conditions except febrile convulsions in children
- Severe hematologic, liver, or kidney dysfunction based on laboratory criteria
- Significant abnormalities on electrocardiography or deemed ineligible by investigators
- Psychiatric surgery, electroconvulsive therapy, or transcranial magnetic stimulation within 90 days before screening
- Use of beta-blockers within 90 days prior to screening requiring continued treatment
- Receiving systemic psychotherapy or non-pharmacological treatments within 6 weeks before baseline
- Dysphagia or inability to tolerate oral medications
- Active gastrointestinal disorders affecting drug absorption
- Use of benzodiazepines or barbiturates within specific timeframes before screening
- Discontinuation of traditional Chinese medicine, melatonin, or St. John's wort less than 3 days before baseline
- Pregnant, breastfeeding, or not willing to use reliable contraception during the study and 28 days after
- Engaged in hazardous mechanical operations such as working at heights or operating motor vehicles
- Participation in another clinical trial within 30 days before screening
- Any other condition deemed ineligible by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230000
Actively Recruiting
Research Team
K
Kai Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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