Randomized Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder
Study Details
Study Description
Brief Summary
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, 440 subjects (final sample size was re-estimated based on the results of stage 1) were randomly assigned to the experimental and placebo groups at a ratio of 1:1.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental: Shugan Jieyu Capsules Participants received Shugan Jieyu Capsules 4 capsules,BID,once in the morning and once in the evening, at an interval of more than 8 hours, for up tp 12 weeks. |
Drug: Shugan Jieyu Capsules
Oral, 4 Capsules, BID
|
| Experimental: Experimental: Shugan Jieyu Capsules+Placepo Participants received Shugan Jieyu Capsules 3 capsules + Placebo 1 capsules,BID,once in the morning and once in the evening, at an interval of more than 8 hours, for up tp 12 weeks. |
Drug: Shugan Jieyu Capsules+Placebo
Drug: Shugan Jieyu Capsules, Oral，3 capsules，BID
Drug: Placebo, Oral, 1 capsule, BID
|
| Placebo Comparator: Experimental: Placebo Participants received placebo 4 capsules,BID,once in the morning and once in the evening, at an interval of more than 8 hours, for up tp 12 weeks. |
Drug: Placebo
Oral，4 capsules，BID
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- 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 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sichuan Jishengtang Pharmaceutical Co., Ltd.
Investigators
- Principal Investigator: Gang Wang, MD, Beijing Anding Hospital Affiliated to Capital Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KH109-CS01-CRP