Clinical trial NCT05772104: Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder
Official title: A Multi-center, Randomized, Double-Blind Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Generalized Anxiety Disorder
Lead sponsor: Chengdu Kanghong Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-03-16
Enrollment: 495
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This trial was a multi-center, randomized, double-blind, two-stage clinical trial in patients with generalized anxiety disorder (TCM differentiated as liver Qi stagnation and spleen deficiency syndrome), consisting of a exploratory study(stage 1) and a confirmatory study(stage 2).

In stage 1, 120 subjects were enrolled and randomly assigned to high-dose group, low-dose group and placebo group at a ratio of 1:1:1.

In stage 2, 495 subjects were randomly assigned to the experimental and placebo groups at a ratio of 1:1.

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.

Primary outcomes:
measure: Change From Baseline in the HAM-A Total Score at Week 12
timeFrame: Change from Baseline to Week 12
Secondary outcomes:
measure: Change From Baseline in the HAM-A Total Score at Week 2, 4, and 8
timeFrame: Change from Baseline to Week 2, 4, and 8
measure: The Proportion of Subjects with HAM-A Total Score Reduction Rate ≥50% at week 2, 4, 8 and 12;
timeFrame: Change from Baseline to Week 2, 4, 8 and 12
measure: The Proportion of Subjects with HAM-A Total Score ≤7 at week 2, 4, 8 and 12
timeFrame: Change from Baseline to Week 2, 4, 8 and 12
measure: Change From Baseline in the HAM-A Mental Anxiety Score at Week 2, 4, 8 and 12
timeFrame: Change from Baseline to Week 2, 4, 8 and 12
measure: Change From Baseline in the HAM-A Somatic Anxiety Score at Week 2, 4, 8 and 12
timeFrame: Change from Baseline to Week 2, 4, 8 and 12
measure: Change From Baseline in the The World Health Organization Quality of Life (WHOQOL)-BREF at Week 2, 4, 8 and 12
timeFrame: Change from Baseline to Week 2, 4, 8 and 12
measure: Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) at Week 2, 4, 8 and 12
timeFrame: Change from Baseline to Week 2, 4, 8 and 12
measure: Change From Baseline in the Clinical Global Impression of Improvement Scale (CGI-I) at Week 2, 4, 8 and 12
timeFrame: Change from Baseline to Week 2, 4, 8 and 12
measure: Change From Baseline in the Traditional Chinese Medicine Syndrome Score Scale at Week 2, 4, 8 and 12
timeFrame: Change from Baseline to Week 2, 4, 8 and 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anding Hospital Affiliated to Capital Medical University
Study officials:
affiliation: Beijing Anding Hospital Affiliated to Capital Medical University
name: Gang Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: