Trazodone on NREM Sleep Stage Ⅲ in Depressed Insomniac Co-morbid Patients (n-REMSS)

Tongji University

Status and phase: Enrolling; Phase 4

Conditions: Depressed Insomniac Co-morbid Patients

Treatments: Drug: Citalopram hydrobromide combined with zolpidem; Drug: 5-hydroxytryptamine balanced antidepressants trazodone

Study type: Interventional

Funder types: Other

Identifiers

NCT06740188

PWRq2024-21

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Intervention group

Experimental group

Description:

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

Treatment:

Drug: 5-hydroxytryptamine balanced antidepressants trazodone

Control group

Active Comparator group

Description:

The control group was given citalopram hydrobromide combined with zolpidem.

Treatment:

Drug: Citalopram hydrobromide combined with zolpidem