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New treatment option for Depressed Insomniac Co-morbid Patients
Official title Trazodone on NREM Sleep Stage Ⅲ in Depressed Insomniac Co-morbid Patients
ClinicalTrials.gov ID: NCT06740188
What this study is testing
What is 5-hydroxytryptamine balanced antidepressants trazodone?
5-hydroxytryptamine balanced antidepressants trazodone is an investigational medicine, being studied as a potential treatment for depressed insomniac co-morbid patients.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- 17 items of Hamilton Depression Rating Scale (HAMD-17) with a total score of ≥ 17 points;
- Pittsburgh Sleep Quality Index (PSQI) ≥ 16 points;
You likely can't join if
- Patients with comorbidities such as schizophrenia, schizophrenia, bipolar disorder, mental retardation, pervasive developmental disorder, delirium...
- Suffering from serious organic diseases, such as diabetes, thyroid disease, hypertension, cardiovascular disease, craniocerebral trauma, cerebral...
- 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;
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.