Shugan Jieyu Capsule for Insomnia Patients With Depressive Symptoms

Study Overview
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Brief Summary
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This study is a randomized, placebo-controlled, double-blind clinical study. 60 cases of insomnia patients with depressive symptoms are planned to be treated, and they are randomly assigned to the experimental group (Shugan Jieyu Capsule combined with zolpidem group) and the control group (placebo combined with zolpidem group) in equal proportion. Both groups are given zolpidem orally for basic treatment, with the treatment dose of 10mg per tablet per day, one tablet per time, once a day, before sleep, for 8 consecutive weeks. The test group was given Shugan Jieyu Capsule orally, with a therapeutic dose of 0.36g per capsule, 2 capsules each time, twice a day, and once after breakfast and dinner. The control group was given placebo orally, with a treatment dose of 0.36g per capsule, 2 capsules each time, twice a day, and once after breakfast and dinner. The therapeutic effect of Shugan Jieyu Capsule on insomnia patients with depressive symptoms was observed by analyzing the changes of ISI scores, subjective and objective sleep indicators (PSG, sleep diary), daytime cognitive function, autonomic nervous function and EEG after the intervention in the fourth and eighth weeks.

Official Title
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Shugan Jieyu Capsule for Insomnia Patients With Depressive Symptoms: A Randomized Double Blind Controlled Study

Conditions
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Insomnia

Intervention / Treatment
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* Drug: Experimental group: Shugan Jieyu Capsule combined with zolpidem
* Drug: Control group: Placebo combined with zolpidem


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Conform to DSM-5 diagnostic criteria for insomnia. Moderate or above depressive symptoms: patient health questionnaire depression scale (PHQ-9) ≥ 10 points. No drug treatment for insomnia and/or depression within one month before the start of this study. 18-60 female or male. Can understand and comply with the research protocol, and can sign a written informed consent. Exclusion Criteria: Shift workers, perennial night shift workers, frequent cross time zone pilots (such as crew members of international flights). PSG examination revealed sleep apnea syndrome (Apnea Hypopnea Index, AHI) ≥ 15 times one hour) and/or periodic limb movement disorder (periodic Limb Movement Index, PLMI] ≥ 15 times one hour). Those who have serious heart disease (such as heart failure, acute myocardial infarction, arrhythmia, coronary heart disease), liver disease (such as hepatitis, cirrhosis, liver cancer, alcoholic liver), lung disease (such as asthma, acute pneumonia, tuberculosis, lung cancer), kidney disease (such as acute and chronic glomerulonephritis, nephrotic syndrome) and other systemic diseases (such as diabetes) that need treatment. Have previously diagnosed mental disorders. Comply with DSM-5 diagnostic criteria for depression Allergic constitution, known or suspected of hypericum perforatum, acanthopanax senticosus and zolpidem allergy history. The past used of zolpidem or Shugan Jieyu capsule was ineffective. Liver function test ALT, AST>2 times the upper limit of reference value, or Scr>the upper limit of reference value. The P450 3A4 inhibitors of liver metabolic cytochrome enzyme have been used within 14 days before randomization, including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, acezotocin, indinavir, nafinavir, linavir, fluvoxamine, and saquinavir. The P450 3A4 inducer of liver metabolic cytochrome enzyme has been used within 14 days before randomization, including but not limited to phenytoin, carbamazepine, barbiturates, rifampicin, St. John's wort, and glucocorticoids. Substance or alcohol dependence (except complete remission and caffeine or nicotine dependence) according to DSM-IV standard at the time of inclusion. The abuse of opioids, amphetamines, barbiturates, cocaine, cannabis or hallucinogens according to DSM-IV standards 4 weeks before enrollment. Medical conditions that affect the absorption, distribution, metabolism or excretion of the study drug. Participated in clinical research of other drugs 4 weeks before enrollment or longer before enrollment according to actual requirements. Pregnant or lactating women. Those who committed serious suicide or committed suicide planning. Other situations unsuitable for inclusion in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group: Shugan Jieyu Capsule combined with zolpidem<br>Zolpidem was given orally for basic treatment, with the treatment dose of 10mg/tablet per day, one tablet per time, once a day, before sleep, for 8 consecutive weeks. Shugan Jieyu Capsule was given orally, with a therapeutic dose of 0.36g/capsule, 2 capsules each time, twice a day, and once after breakfast and dinner. | Drug: Experimental group: Shugan Jieyu Capsule combined with zolpidem<br>* Shugan Jieyu capsule and zolpidem orally for 8 consecutive weeks<br>|
| Placebo Comparator: Control group: Placebo combined with zolpidem<br>Zolpidem was given orally for basic treatment, with the treatment dose of 10mg/tablet per day, one tablet per time, once a day, before sleep, for 8 consecutive weeks. Placebo was given orally, with a therapeutic dose of 0.36g/capsule, 2 capsules each time, twice a day, and once after breakfast and dinner. | Drug: Control group: Placebo combined with zolpidem<br>* Placebo and zolpidem orally for 8 consecutive weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia severity index scale | Changes in insomnia severity index scale | Baseline and four, eight weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh sleep quality index scale | Changes in pittsburgh sleep quality index scale | Baseline and four, eight weeks after treatment | 
| Patient health questionnaire | Changes in patient health questionnaire | Baseline and four, eight weeks after treatment | 
| Facade severity scale | Changes in facade severity scale | Baseline and four, eight weeks after treatment | 
| Epworth sleeping scale | Changes in epworth sleeping scale | Baseline and four, eight weeks after treatment | 
| Polysomnography | Changes in the time to fall asleep, times of waking up at midnight and times of waking up early | Baseline and four, eight weeks after treatment | 
| Sleep diary | Changes in the time to fall asleep, the total time to wake up in the middle of the night and the time to wake up early | Baseline and four, eight weeks after treatment | 
| Generalized anxiety disorder scale | Changes in generalized anxiety disorder scale | Baseline and four, eight weeks after treatment | 
| Beck scale for suicide ideation--Chinese Version scale | Changes in beck scale for suicide ideation--Chinese Version scale | Baseline and four, eight weeks after treatment | 
| Concise happiness and quality of life satisfaction questionnaire | Changes in concise happiness and quality of life satisfaction questionnaire | Baseline and four, eight weeks after treatment | 
| Event-related potential | Changes in P300 latency | Baseline and four, eight weeks after treatment | 
| Heart rate variability analysis | Changes in low frequency, high frequency, very low frequency, low frequency/high frequency | Baseline and four, eight weeks after treatment | 
| N-back paradigm task | Changes in reaction time and accuracy | Baseline and four, eight weeks after treatment | 
| Suicide stroop task | Changes in reaction time and accuracy | Baseline and four, eight weeks after treatment | 
| Go/no-go association task | Changes in reaction time and accuracy | Baseline and four, eight weeks after treatment | 
| Psychomotor vigilance task | Changes in reaction time | Baseline and four, eight weeks after treatment |