Generalized Anxiety Disorder
Conditions
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.
Interventions
Oral, 4 Capsules, BID
DRUGShugan Jieyu Capsules Placebo
Drug: Shugan Jieyu Capsules Placebo, Oral，4 capsules，BID Drug: Placebo, Oral, 1 capsule, BID
Sponsors
Sichuan Jishengtang Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the HAM-A Total Score at Week 12 | Change from Baseline to 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Subjects with HAM-A Total Score Reduction Rate ≥50% at week 2, 4, 8 and 12; | Change from Baseline to 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 | Change from Baseline to 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 | Change from Baseline to 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. |
| Change From Baseline in the HAM-A Somatic Anxiety Score at Week 2, 4, 8 and 12 | Change from Baseline to Week 2, 4, 8 and 12 | The HAM-A Somatic Anxiety Factor Score was the sum of Items 7 to 13 and could have ranged from 0 to 28. |
| Change From Baseline in the HAM-A Total Score at Week 2, 4, and 8 | Change from Baseline to 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. |
| Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) at Week 2, 4, 8 and 12 | Change from Baseline to Week 2, 4, 8 and 12 | The CGI-S is measures the clinician's impression of a subject's current anxiety severity considering their total clinical experience with the patient population. This measure uses a 0-7 scale, with higher scores indicating greater anxiety severity. |
| Change From Baseline in the Clinical Global Impression of Improvement Scale (CGI-I) at Week 2, 4, 8 and 12 | Change from Baseline to Week 2, 4, 8 and 12 | CGI-I measured the clinician's perception of the participant's improvement at the time of assessment compared with the baseline. Scores could have ranged from 1 (very much improved) to 7 (very much worse). |
| Change From Baseline in the Traditional Chinese Medicine Syndrome Score Scale at Week 2, 4, 8 and 12 | Change from Baseline to Week 2, 4, 8 and 12 | TCM syndrome scale was used to evaluate the changes of TCM symptoms and signs before and after treatment. |
| Change From Baseline in the The World Health Organization Quality of Life (WHOQOL)-BREF at Week 2, 4, 8 and 12 | Change from Baseline to Week 2, 4, 8 and 12 | The scale evaluates the quality of life in four areas: physiology, psychology, social relations and environment. |
Countries
China
Contacts
Primary ContactLing Song
Outcome results
None listed