Clinical trial NCT05764798: Shugan Jieyu Capsule for Insomnia Patients With Depressive Symptoms
Official title: Shugan Jieyu Capsule for Insomnia Patients With Depressive Symptoms: A Randomized Double Blind Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Insomnia
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Insomnia severity index scale
timeFrame: Baseline and four, eight weeks after treatment
Secondary outcomes:
measure: Pittsburgh sleep quality index scale
timeFrame: Baseline and four, eight weeks after treatment
measure: Patient health questionnaire
timeFrame: Baseline and four, eight weeks after treatment
measure: Facade severity scale
timeFrame: Baseline and four, eight weeks after treatment
measure: Epworth sleeping scale
timeFrame: Baseline and four, eight weeks after treatment
measure: Polysomnography
timeFrame: Baseline and four, eight weeks after treatment
measure: Sleep diary
timeFrame: Baseline and four, eight weeks after treatment
measure: Generalized anxiety disorder scale
timeFrame: Baseline and four, eight weeks after treatment
measure: Beck scale for suicide ideation--Chinese Version scale
timeFrame: Baseline and four, eight weeks after treatment
measure: Concise happiness and quality of life satisfaction questionnaire
timeFrame: Baseline and four, eight weeks after treatment
measure: Event-related potential
timeFrame: Baseline and four, eight weeks after treatment
measure: Heart rate variability analysis
timeFrame: Baseline and four, eight weeks after treatment
measure: N-back paradigm task
timeFrame: Baseline and four, eight weeks after treatment
measure: Suicide stroop task
timeFrame: Baseline and four, eight weeks after treatment
measure: Go/no-go association task
timeFrame: Baseline and four, eight weeks after treatment
measure: Psychomotor vigilance task
timeFrame: Baseline and four, eight weeks after treatment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Bin Zhang, MD & PhD
role: PRINCIPAL_INVESTIGATOR
References: