Generalized Anxiety Disorder
Conditions
Interventions
Experimental group:Crisugabalin
Venlafaxine Extended-Release Capsule Control Group:Venlafaxine
Sponsors
The first affiliated hospital of anhui medical university
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Able to understand and voluntarily participate in the trial, and provide written informed consent form (ICF); 2.Male or female aged =18 years (inclusive of the threshold value); 3.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.); 4.Require pharmacological treatment for psychiatric symptoms; 5.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;
Exclusion criteria
Exclusion criteria: 1. the patient is currently at serious risk of suicide or has a HAMD-17 Section 3 - Suicide Score >= 3; 2. a HAMD-17 score > 17; 3. those with a >=20% reduction in HAMA scale score at baseline compared to screening; 4. the presence of a mental disorder other than GAD that currently meets DSM-V diagnostic criteria for a mental disorder; 5. patients with previous depression, obsessive-compulsive disorder, bipolar disorder, psychotic disorders, doing disorders, and somatoform disorders; and the presence of severe personality disorders, particularly antisocial, borderline, or performative personality disorders, which, in the judgement of the investigator, would interfere with the patient's adherence to the study protocol; 6. persons with alcohol or drug abuse or dependence within 180 days prior to screening; 7. those with serious or unstable clinically significant physical illnesses, including any cardiovascular, neoplastic, renal, respiratory, endocrine (including abnormal thyroid function), gastrointestinal, haematological (e.g., those with a tendency to haemorrhage) or neurological conditions; 8. Previous treatment with 2 or more antidepressants and/or benzodiazepines in full dosage and duration, i.e., at clinically appropriate doses for at least 4 weeks, which remains ineffective, or use of pregabalin >= 300 mg/day with declared poor efficacy or lack of clinical efficacy; 9. Persons with prior severe hypersensitivity, or persons with allergies to at least 2 classes of drugs (including photosensitivity), or a history of allergy to pregabalin, experimental drugs, or other chemically structurally similar drugs or excipients; 10. Abnormal and clinically significant vital signs during the screening period (e.g., poorly controlled hypertension with systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg despite active treatment); 11. those with a history of epilepsy or any other condition that may induce seizures, except for convulsions due to febrile convulsions in childhood; 12. Presence of severe haematological, hepatic and renal function abnormalities during the screening period, as indicated by any of the following clinical laboratory test results; 1) Haematology: neutrophils 2.5 x upper limit of normal (ULN), or total bilirubin (TBIL) > 1.5 x ULN; 3) Estimated glomerular filtration rate (eGFR) 2.0 x ULN; 13. clinically significant abnormalities on electrocardiogram (ECG) examination during the screening period (e.g., ECG QTcF: >=450 ms in men and >=470 ms in women), or conditions deemed inappropriate for enrolment by the investigator; 14. those who have undergone psychosurgery or have undergone electroconvulsive therapy or transcranial magnetic stimulation within 90 days prior to screening; 15. who have used beta-blocker therapy within 90 days prior to screening and who require ongoing user; 16. those who have had systemic psychotherapy, or other non-pharmacological treatments (e.g., acupuncture, hypnosis, or light therapy) within 6 weeks prior to the baseline visit 17. patients with active gastrointestinal disease (including any history of gastrointestinal surgery) who, in the judgement of the investigator, have said disease or surgery that may interfere with the absorption of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Hamilton anxiety scale score after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of HAMA Complete Remission Rates (Proportion of Patients with HAMA Scale Total Score <=7) Between Kligabalin and Placebo;Clinical global impression of improvement score;Safety;Response rate;Change in Hamilton anxiety scale score after treatment;Change in each factor score and item score of Hamilton anxiety scale;Rapid-onset rate;Clinical global impression of severity score; | — |
Countries
China
Contacts
Public ContactKai Wang
The first affiliated hospital of anhui medical university
Outcome results
None listed