Trazodone on NREM Sleep Stage Ⅲ in Depressed Insomniac Co-morbid Patients

Impact of Trazodone on Non-rapid Eye Movement Sleep Stage Ⅲ in Depressed Insomniac Co-morbid Patients: A Randomized Controlled Trial

Trazodone on NREM Sleep Stage Ⅲ in Depressed Insomniac Co-morbid Patients (NCT06740188) is a Phase 4 interventional studying Depressed Insomniac Co-morbid Patients, sponsored by Tongji University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

This study used polysomnographic technology and randomly selected 60 patients who met the diagnostic criteria for depression and non-organic insomnia as stipulated in DSM-5 into an intervention group (n=30) and a control group (n=30). The intervention group was given only 5-hydroxytryptamine balanced antidepressants trazodone, while the control group was given citalopram hydrobromide combined with zolpidem. Both groups underwent PSG at baseline and 1 week after medication, and were assessed with the 17-item Hamilton Depression Rating Scale, Zung Self-Rating Depression Scale, Pittsburgh Sleep Quality Index, Arnsworth Insomnia Severity Scale, Antidepressant Side Effects Checklist, and the Drug Dependence Scale neuropsychological assessment at baseline, 1, 2, and 4 weeks after medication. The study aimed to explore the effects of single use of SMAs class antidepressants versus combination with other antidepressants on non-rapid eye movement sleep stage III in patients with depression and insomnia comorbidity, and to compare the effects of depression and insomnia in the two groups.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 60 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Depressed Insomniac Co-morbid Patients subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Outpatient or inpatient patients; - 18 years old ≤ 65 years old; - Simultaneously meet the diagnostic criteria for depression and non organic insomnia in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) in the United States; - 17 items of Hamilton Depression Rating Scale (HAMD-17) with a total score of ≥ 17 points; - Pittsburgh Sleep Quality Index (PSQI) ≥ 16 points; - Never used related antidepressants and sedative hypnotic drugs; - Has a certain level of visual and auditory resolution, and no comprehension barriers; - Capable of independently completing scale measurements; - Education level above primary school; - Obtain written willing to sign a consent form from the patient, and obtain written willing to sign a consent form from the legal guardian if the patient is incapacitated during the onset of the illness. Who Should NOT Join This Trial: - Patients with comorbidities such as schizophrenia, schizophrenia, bipolar disorder, mental retardation, pervasive developmental disorder, delirium, dementia, cognitive impairment, alcohol dependence, etc - Suffering from serious organic diseases, such as diabetes, thyroid disease, hypertension, cardiovascular disease, craniocerebral trauma, cerebral ischemia or hemorrhage; - Patients with narrow angle glaucoma; - History of epilepsy and febrile seizures; - Individuals with a history of drug use; - Positive for syphilis specific antibody and AIDS antibody; - According to risk assessment, there are currently serious suicide attempts or individuals who are overly agitated Pregnant or lactating women, or those planning to conceive in the near future; - Laboratory tests indicate the presence of liver and kidney function impairment in individuals; - There are other individuals who meet the relevant contraindications for antidepressants. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Outpatient or inpatient patients; * 18 years old ≤ 65 years old; * Simultaneously meet the diagnostic criteria for depression and non organic insomnia in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) in the United States; * 17 items of Hamilton Depression Rating Scale (HAMD-17) with a total score of ≥ 17 points; * Pittsburgh Sleep Quality Index (PSQI) ≥ 16 points; * Never used related antidepressants and sedative hypnotic drugs; * Has a certain level of visual and auditory resolution, and no comprehension barriers; * Capable of independently completing scale measurements; * Education level above primary school; * Obtain written informed consent from the patient, and obtain written informed consent from the legal guardian if the patient is incapacitated during the onset of the illness. Exclusion Criteria: * Patients with comorbidities such as schizophrenia, schizophrenia, bipolar disorder, mental retardation, pervasive developmental disorder, delirium, dementia, cognitive impairment, alcohol dependence, etc * Suffering from serious organic diseases, such as diabetes, thyroid disease, hypertension, cardiovascular disease, craniocerebral trauma, cerebral ischemia or hemorrhage; * Patients with narrow angle glaucoma; * History of epilepsy and febrile seizures; * Individuals with a history of drug use; * Positive for syphilis specific antibody and AIDS antibody; * According to risk assessment, there are currently serious suicide attempts or individuals who are overly agitated Pregnant or lactating women, or those planning to conceive in the near future; * Laboratory tests indicate the presence of liver and kidney function impairment in individuals; * There are other individuals who meet the relevant contraindications for antidepressants.

Treatments Being Tested

DRUG

5-hydroxytryptamine balanced antidepressants trazodone

The intervention group was given only 5-hydroxytryptamine balanced antidepressants trazodone

DRUG

Citalopram hydrobromide combined with zolpidem

the control group was given citalopram hydrobromide combined with zolpidem

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Tongji University

Shanghai, Shanghai Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06740188), the sponsor (Tongji University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06740188 clinical trial studying?

Who can participate in NCT06740188?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06740188?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06740188. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06740188. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.