Genernal Anxiaty Disorder
Conditions
Interventions
Ganoderic acid A group:Akashi Capsule 4 capsules (daily in the morning)
Analog drug control group:Chizhi Capsules Analog 4 Capsules(daily in the morning)
Sponsors
Capital Medical University, Beijing Anding Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Outpatients or inpatients aged 18-65 years (both 18 and 65 years), regardless of gender; (2) Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for generalized anxiety disorder; (3) Have a Hamilton Anxiety Scale (HAMA) score of =14 and =28 at screening and baseline; (4) HAMA entry 1 (anxious mind) score =2 at screening and baseline; (5) Primary school education or above, able to understand the content of the study; (6) Understand and voluntarily participate in this study, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Subjects may not be included in this study if any of the following exclusion criteria are met: (1) Persons with the following other psychiatric disorders that meet DSM-5 diagnostic criteria: including Major Depressive Disorder (MDD) within 6 months prior to screening, previous or current schizophrenia spectrum or other psychotic disorders, bipolar or related disorders, obsessive-compulsive and related disorders, and other psychotic disorders, trauma and stress-related disorders, anorexia nervosa or bulimia nervosa, and personality disorders within 6 months prior to screening. and personality disorders, etc; (2) History of suicide attempt within 6 months prior to screening; or high suicide risk at screening or baseline; or MADRS Section 10 (Suicide Score) = 4; (3) Persons with a substance-related or alcohol use disorder (other than nicotine or caffeine) in the 6 months prior to screening (meeting DSM-5 diagnostic criteria); (4) Anxiety symptoms and psychoactive substance-induced anxiety secondary to a somatic illness or other mental disorder (e.g., delusions, depression, obsessive-compulsive, etc.); (5) Montgomery-Asberg Depression Rating Scale (MADRS) =22 points at screening or baseline; (6) Previous treatment with 2 or more anxiolytics with different mechanisms of action that have been ineffective or of minimal efficacy with a full dosage and regimen (e.g., at least 4 weeks of treatment at the maximum dose indicated); (7) Those with serious or unstable physical illnesses, including any cardiovascular, neoplastic, renal, respiratory, endocrine, gastrointestinal, hematologic, or neurologic conditions; (8) Those who have not discontinued psychotropic medications for 5 half-lives (at least 2 weeks for monoamine oxidase inhibitors and at least 1 month for fluoxetine) prior to randomization; (9) Those who had received psychosurgery or systemic psychiatric physical therapy, such as MECT or Transcranial Magnetic Stimulation (TMS), Deep Brain Stimulation (DBS), in the 3 months prior to screening. Brain Stimulation (DBS), Vagus Nerve Stimulation (VNS); (10) Those who have received systemic psychotherapy or other non-pharmacological treatments for psychiatric disorders (e.g., acupuncture or light therapy, etc.) within 6 weeks prior to screening; (11) Allergy to Ganoderma lucidum or Ganoderic acid A; (12) Subjects who are pregnant or breastfeeding at Screening or Baseline, or subjects with a positive pregnancy test, or males of reproductive potential or females of childbearing age who are unable to use effective contraception during the study; or who plan to conceive (inseminate) within 3 months of study entry; (13) Subjects who have participated in a clinical trial of another drug and received the test drug within 3 months prior to the first dose; (14) Subjects who, in the opinion of the investigator, are not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Montgomery-Asberg Depression Scale (MARDS));Clinical Global Impression (CGI);Sheehan Disability Scale (SDS);Generalized Anxiety Disorder (GAD-7);State-Trait Anxiety Inventory (STAI);Health Questionnaire-15 (PHQ-15);Short Form of Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF);Pittsburgh sleep quality index (PSQI);Perceived Deficits Questionnaire-Depression (PDQ-D);Digit symbol substitution test (DSST); | — |
Countries
China
Contacts
Public ContactXu Jinjie
Capital Medical University, Beijing Anding Hospital
Outcome results
None listed