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

Phase 4

Recruiting

• Conditions: Depressed Insomniac Co-morbid Patients
• Interventions: Drug: 5-hydroxytryptamine balanced antidepressants trazodone; Drug: Citalopram hydrobromide combined with zolpidem

• Registration Number: NCT06740188
• Lead Sponsor: Tongji University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2024-12-13
• Study First Posted: 2024-12-18
• Study Start: 2025-01-01
• Last Update Submitted: 2025-02-16
• Last Update Posted: 2025-02-19
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	5-hydroxytryptamine balanced antidepressants trazodone	The intervention group was given only 5-hydroxytryptamine balanced antidepressants trazodone.
Control group	Citalopram hydrobromide combined with zolpidem	The control group was given citalopram hydrobromide combined with zolpidem.

Primary Outcome Measures

Name	Time	Method
Sleep structure staging	Baseline and 1 week after medication	Monitoring sleep structure staging through Polysomnography（PSG）: W period (awake period): Refers to the time when one has not entered a sleep state； N1 stage (non rapid eye movement stage 1): light sleep stage, accounting for about 5-10%； N2 stage (non rapid eye movement stage 2): The main part of sleep, accounting for about 50%； N3 stage (non rapid eye movement stage 3): Deep sleep stage, accounting for about 20%, is crucial for memory consolidation and recovery； R phase (rapid eye movement phase): related to dreams, accounting for about 20-25%.

Secondary Outcome Measures

Name	Time	Method
The 17 item Hamilton Depression Scale (HAMD-17)	baseline, 1, 2, and 4 weeks after medication	The 17 item Hamilton Depression Scale (HAMD-17) evaluates the severity of depression and treatment outcomes in patients. Composed of 17 items, ranging from 7 to 13 points, it is classified as mild depression; 14-19 points are classified as moderate depression; ≥ 20 points is classified as severe or above.
Zong's Self rating Depression Scale (SDS)	baseline, 1, 2, and 4 weeks after medication	Zong's Self rating Depression Scale (SDS): It can intuitively reflect the subjective feelings of depressed patients and their symptom changes during treatment. Composed of 20 items, the severity is rated on a 4-point scale from 1 to 4, with 53-62 indicating mild depression, 63-72 indicating moderate depression, and ≥ 72 indicating severe depression.
The Pittsburgh Sleep Quality Index (PSQI)	baseline, 1, 2, and 4 weeks after medication	The Pittsburgh Sleep Quality Index (PSQI) evaluates a patient's sleep quality over the past month, including sleep outcomes and duration. There are a total of 18 items and 7 dimensions, each item is rated on a 4-point scale from 0 to 3. The higher the score, the worse the sleep quality.
The Athens Insomnia Scale (AIS)	baseline, 1, 2, and 4 weeks after medication	The Athens Insomnia Scale (AIS) can be used as a subjective evaluation of insomnia in patients. Composed of 8 items, the severity is evaluated using a 4-point scale from 0 to 3, with a total score range of 0 to 24 points. The higher the score, the worse the sleep quality.
The Antidepressant Side Effect Checklist (ASEC)	baseline, 1, 2, and 4 weeks after medication	The Antidepressant Side Effect Checklist (ASEC) evaluates the adverse reactions of patients after using antidepressants, including physical fatigue, dizziness, headache, sleep disturbances, erectile dysfunction, palpitations, tremors, sweating, dry mouth, constipation, urinary disorders, drowsiness, sexual dysfunction, and other symptoms. Composed of 21 items, the severity is evaluated using a 4-point scale from 0 to 3, with higher scores indicating more severe side effects. evaluates the adverse reactions of patients after using antidepressants, including physical fatigue, dizziness, headache, sleep disturbances, erectile dysfunction, palpitations, tremors, sweating, dry mouth, constipation, urinary disorders, drowsiness, sexual dysfunction, and other symptoms. Composed of 21 items, the severity is evaluated using a 4-point scale from 0 to 3, with higher scores indicating more severe side effects.
Drug Dependence Scale (DDS)	baseline, 1, 2, and 4 weeks after medication	Drug Dependence Scale (DDS) used to identify the degree of drug use dependence. This scale adopts a 4-point rating system, with higher scores indicating higher levels of drug dependence.

Trial Locations

Locations (1)

Tongji University; 🇨🇳 Shanghai, Shanghai, China