anxiety disorder
Conditions
Interventions
Control group:Mock tablets of Cordyceps militaris without active ingredients, 6 tablets/day for 4 weeks
Research group:Cordyceps militaris tablets, 6 tablets per day for 4 weeks
Sponsors
Beijing Anding Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients who met all of the following criteria were admitted to the study: (1) Meet the DSM-5 diagnostic criteria for generalized anxiety disorder; (2) HAMA scores in the screening period and baseline period ranged from 14 to 28; (3) Age 18-65 years old, gender unlimited, primary school education or above; (4) Patients who had not taken antidepressants for at least 14 days prior to enrollment (patients treated with fluoxetine prior to enrollment) Stop taking the drug for at least 28 days); (5) The patient signs the informed consent.
Exclusion criteria
Exclusion criteria: Subjects will not be included in the study if any of the following exclusion criteria are met: (1) Meet the DSM-5 diagnosis of other mental disorders, including major depressive disorder (MDD) within 6 months prior to screening, previous or current schizophrenia spectrum or other psychiatric disorders, bipolar or related disorders, compulsive and related disorders, trauma and stress-related disorders, anorexia nervosa or bulimia, and personality disorders; (2) A history of attempted suicide within 6 months prior to first dosing, or a high risk of suicide at screening or baseline; Or HAMD-17 suicide risk entries =3 points; (3) with serious or unstable physical diseases, including any cardiovascular, oncological, renal, respiratory, endocrine, digestive, blood or nervous system diseases; (4) discontinuation of psychotropic drugs for less than 5 half-life periods (monoamine oxidase inhibitors for at least 2 weeks, fluoxetine for at least 1 month) before randomization; (5) Those who were receiving systematic psychotherapy or other non-pharmacological treatment for psychiatric disorders (such as acupuncture or light therapy) at the time of screening and/or baseline, and who still required such treatment during the study period; (6) Persons who have undergone psychiatric surgery or systematic physical therapy within 3 months prior to initial dosing, including but not limited to: Modified Electric Convulsive Therapy (MECT), Transcranial Magnetic Stimulation (Transcranial Magnetic Stimulation), TMS), Vagus Nerve Stimulation (VNS), Deep Brain Stimulation (DBS), etc. (7) At least 2 previous antidepressants with different mechanisms of action in full doses and full courses of treatment (e.g., at least 4 weeks of maximum dose according to the instructions) are not effective; (8) The score of HAMA-14 at baseline decreased by =25% compared with the screening; (9) During the screening period, ALT and/or AST = 2 times the upper limit of normal, or total bilirubin and/or direct bilirubin = 1.5 times the upper limit of normal, or serum creatinine = 1.5 times the upper limit of normal; (10) ECG abnormalities at screening or baseline were clinically significant, such as QTc=450ms for men and 470ms for women; (11) Allergic to cordycepin; (12) Subjects who were pregnant or breastfeeding at the time of screening or baseline, subjects who tested positive for pregnancy, or men or women of reproductive age who had reproductive potential during the study period were unable to use effective contraception; Or plan to become pregnant within 3 months of the start of the study; (13) Those who have participated in other drug clinical trials and received investigational drugs within 3 months before the first dose; (14) Subjects deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| According to HAMA, the score reduction value and score reduction rate of the total score of the first, second and fourth weekends of treatment were evaluated compared with the baseline.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effective rate: The percentage of patients with HAMA score reduction rate =50% at each follow-up point compared with baseline, and the difference in effective rate between groups;;Complete response rate: The proportion of patients with total HAMA =7 at each follow-up point, and the difference in complete response rate between groups;Changes of SAS scores from baseline at each follow-up point and differences between groups;;Changes in CGI scores from baseline at each follow-up point and differences between groups;Changes of SDS scores from baseline at each follow-up point and differences between groups;Changes in GAD-7 scores from baseline at each follow-up point and differences between groups;Changes in STAI scores from baseline at each follow-up point and differences between groups;Changes in PHQ-15 scores from baseline at each follow-up point and differences between groups;Changes in PSQI scores from baseline at each follow-up point and differences between groups;Changes in heart rate from baseline at each follow-up point and differences between groups; | — |
Countries
China
Contacts
Public ContactYing Li
Beijing Anding Hospital
Outcome results
None listed