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NCT Number: NCT05772104

Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder

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.

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Anding Hospital Affiliated to Capital Medical University

Beijing, China

Location status: Recruiting

Location contact

Gang Wang

CONTACT

[email protected]

+8613911695727

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shugan Jieyu Capsules

Drug

Oral, 4 Capsules, BID

Shugan Jieyu Capsules Placebo

Drug

Drug: Shugan Jieyu Capsules Placebo, Oral，4 capsules，BID

Drug: Placebo, Oral, 1 capsule, BID

Primary outcomes

  1. Change From Baseline in the HAM-A Total Score at Week 12

    Time frame: 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 outcomes

  1. Change From Baseline in the HAM-A Total Score at Week 2, 4, and 8

    Time frame: 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.

  2. The Proportion of Subjects with HAM-A Total Score Reduction Rate ≥50% at week 2, 4, 8 and 12;

    Time frame: 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.

  3. The Proportion of Subjects with HAM-A Total Score ≤7 at week 2, 4, 8 and 12

    Time frame: 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.

  4. Change From Baseline in the HAM-A Mental Anxiety Score at Week 2, 4, 8 and 12

    Time frame: 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.

  5. Change From Baseline in the HAM-A Somatic Anxiety Score at Week 2, 4, 8 and 12

    Time frame: 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.

  6. Change From Baseline in the The World Health Organization Quality of Life (WHOQOL)-BREF at Week 2, 4, 8 and 12

    Time frame: 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.

  7. Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) at Week 2, 4, 8 and 12

    Time frame: 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.

  8. Change From Baseline in the Clinical Global Impression of Improvement Scale (CGI-I) at Week 2, 4, 8 and 12

    Time frame: 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).

  9. Change From Baseline in the Traditional Chinese Medicine Syndrome Score Scale at Week 2, 4, 8 and 12

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ling Song

CONTACT

[email protected]

028-81258178

Sponsors and collaborators

Lead sponsor

Sichuan Jishengtang Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 16, 2023
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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