Testing Shugan Jieyu Capsule for Generalized Anxiety Disorder

A Multi-center, Randomized, Double-Blind Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder

This study is testing if Shugan Jieyu Capsules can help people with generalized anxiety disorder feel better compared to a placebo.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 495 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Chengdu Kanghong Pharmaceutical Group Co., Ltd. (industry)
• Locations: 1 site (Beijing)
• Trial ID: NCT05772104 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, double-blind, placebo-controlled phase 3 study aimed at evaluating the effectiveness and safety of Shugan Jieyu Capsules in treating generalized anxiety disorder (GAD). The trial consists of two stages: an exploratory study with 120 participants and a confirmatory study with 495 participants, both assessing the capsules against a placebo. Participants are diagnosed with GAD and classified under traditional Chinese medicine as having liver Qi stagnation and spleen deficiency syndrome. The study will measure outcomes using standardized anxiety scales to determine the capsules' impact on symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a primary diagnosis of generalized anxiety disorder lasting at least 6 months.

Not a fit: Patients with other psychiatric disorders, substance abuse issues, or severe depression may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from generalized anxiety disorder.

How similar studies have performed: While this approach is based on traditional Chinese medicine, similar studies have shown promise in treating anxiety disorders, though this specific treatment is less commonly tested.

Eligibility criteria

Inclusion Criteria:

1. 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；
2. Age 18-65 years old；
3. Hamilton Anxiety Rating Scale (HAM-A) Total Score of ≥ 14 at both Screening and Baseline，Anxious Mood (item 1) score ≥2；
4. Clinical Global Impression of Severity Scale (CGI-S) score of ≥ 3 at both Screening and Baseline
5. The TCM syndrome is liver Qi stagnation and spleen deficiency syndrome.

Exclusion Criteria:

1. Diagnosed with a psychiatric disorder other than GAD that meets DSM-5 criteria within 6 months prior to screening；
2. Alcohol or drug abuse or dependence in the 6 months prior to screening, or urine positive for multiple drugs combined at screening
3. Hamilton Depression Rating Scale (HAMD-17) Total Score of \> 17 at Screening or Baseline，or Depressive Mood (item 1) score ≥2；
4. Patients with Severe Insomnia.

Where this trial is running

Beijing

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

Study contacts

• Principal investigator: Gang Wang, MD — Beijing Anding Hospital Affiliated to Capital Medical University
• Study coordinator: Ling Song

Conditions: Generalized Anxiety Disorder