Shugan Jieyu Capsule for Insomnia Patients With Depressive Symptoms

Phase 1

Recruiting

• Conditions: Insomnia

• Registration Number: NCT05764798
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-11
• Study Start: 2022-11-30
• Study First Submitted: 2023-02-19
• Study First Submitted QC: 2023-02-28
• Last Update Submitted: 2023-02-28
• Study First Posted: 2023-03-13
• Last Update Posted: 2023-03-13
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Insomnia severity index scale	Baseline and four, eight weeks after treatment	Changes in insomnia severity index scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China