Effects of Trazodone on Sleep in Patients with Depression and Insomnia

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

This study is testing if trazodone can improve sleep for people who have both depression and insomnia compared to a different treatment.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Tongji University (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06740188 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the impact of trazodone, a 5-hydroxytryptamine balanced antidepressant, on non-rapid eye movement sleep stage III in patients diagnosed with both depression and non-organic insomnia. A total of 60 patients are randomly assigned to either an intervention group receiving trazodone or a control group receiving citalopram combined with zolpidem. Both groups undergo polysomnographic assessments at baseline and one week after treatment, along with various depression and sleep quality scales at multiple time points. The study aims to determine the efficacy of trazodone compared to a combination therapy on sleep improvement in this patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 65 who meet the DSM-5 criteria for depression and non-organic insomnia.

Not a fit: Patients with comorbid psychiatric disorders such as schizophrenia or bipolar disorder may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for improving sleep quality in patients suffering from both depression and insomnia.

How similar studies have performed: Previous studies have shown promising results with trazodone in treating insomnia, suggesting potential success for this approach.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Tongji University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Meiling Liu, M.M.

Conditions Depressed Insomniac Co-morbid Patients; Trazodone; Non-rapid Eye Movement Sleep Stage; depression; insomnia