Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Generalized Anxiety Disorder

In brief

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.

Key facts

Study ID

NCT05772104

Run by

Sichuan Jishengtang Pharmaceutical Co., Ltd.

People needed

495

Starts

2023-04-17

Expected to finish

2025-06-01

Last updated by the study team

2024-12-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• The TCM syndrome is liver Qi stagnation and spleen deficiency syndrome.

You may not qualify if…

• 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.

Where it is running

• Beijing Anding Hospital Affiliated to Capital Medical University — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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