This is a randomized double-blind placebo-controlled phase 3 clinical trial to further validate the effectiveness and safety of Shugan Jieyu Capsules in treating generalized anxiety disorder.
Primary diagnosis of generalized anxiety disorder (GAD) as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) as confirmed by the MINI at Screening, The duration of illness must be ≥ 6 months；
Age 18-65 years old；
Hamilton Anxiety Rating Scale (HAM-A) Total Score of ≥ 14 at both Screening and Baseline，Anxious Mood (item 1) score ≥2；
Clinical Global Impression of Severity Scale (CGI-S) score of ≥ 3 at both Screening and Baseline
Diagnosed with a psychiatric disorder other than GAD that meets DSM-5 criteria within 6 months prior to screening；
Alcohol or drug abuse or dependence in the 6 months prior to screening, or urine positive for multiple drugs combined at screening
Hamilton Depression Rating Scale (HAMD-17) Total Score of > 17 at Screening or Baseline，or Depressive Mood (item 1) score ≥2；
Patients with Severe Insomnia.
Parallel
Shugan Jieyu Capsules
DrugOral, 4 Capsules, BID
Shugan Jieyu Capsules Placebo
DrugDrug: Shugan Jieyu Capsules Placebo, Oral，4 capsules，BID Drug: Placebo, Oral, 1 capsule, BID
Change From Baseline in the HAM-A Total Score at Week 12
The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.
Change From Baseline in the HAM-A Total Score at Week 2, 4, and 8
The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.
The Proportion of Subjects with HAM-A Total Score Reduction Rate ≥50% at week 2, 4, 8 and 12;
The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.
The Proportion of Subjects with HAM-A Total Score ≤7 at week 2, 4, 8 and 12
The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.
Change From Baseline in the HAM-A Mental Anxiety Score at Week 2, 4, 8 and 12
HAM-A Mental Anxiety Score was the sum of Items 1 to 6 and Item 14 and could have ranged from 0 to 28.
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