Shugan Jieyu Capsule for Insomnia Patients With Depressive Symptoms

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

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.

Study Overview

• Status: Recruiting
• Conditions: Insomnia
• Intervention / Treatment: Drug: Experimental group: Shugan Jieyu Capsule combined with zolpidem; Drug: Control group: Placebo combined with zolpidem

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Bin Zhang, MD & PhD; Phone Number: 86-20-62786731; Email: zhang73bin@hotmail.com
• Study Contact Backup: Name: Meilei Su, MD; Phone Number: 86-20-62786731; Email: sumeilei@126.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital, Southern Medical University
      • Contact: Bin Zhang, MD＆PHD; Email: zhang73bin@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group: Shugan Jieyu Capsule combined with zolpidem; 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; Shugan Jieyu capsule and zolpidem orally for 8 consecutive weeks
Placebo Comparator: Control group: Placebo combined with zolpidem; 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; Placebo and zolpidem orally for 8 consecutive weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University
• Investigators: Principal Investigator: Bin Zhang, MD & PhD, Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Anticipated): December 30, 2024
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: February 19, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Depression; Sleep Initiation and Maintenance Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Hypnotics and Sedatives; GABA Agents; Sleep Aids, Pharmaceutical; GABA-A Receptor Agonists; GABA Agonists; Zolpidem
• Other Study ID Numbers: NFEC-2023-030

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No