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

Last updated: February 16, 2025
Sponsor: Tongji University
Overall Status: Active - Recruiting

Phase

4

Condition

Depression

Treatment

Citalopram hydrobromide combined with zolpidem

5-hydroxytryptamine balanced antidepressants trazodone

Clinical Study ID

NCT06740188
PWRq2024-21
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Outpatient or inpatient patients;

  • 18 years old ≤ 65 years old;

  • Simultaneously meet the diagnostic criteria for depression and non organic insomniain 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 ≥ 17points;

  • 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 comprehensionbarriers;

  • Capable of independently completing scale measurements;

  • Education level above primary school;

  • Obtain written informed consent from the patient, and obtain written informedconsent from the legal guardian if the patient is incapacitated during the onset ofthe illness.

Exclusion

Exclusion Criteria:

  • Patients with comorbidities such as schizophrenia, schizophrenia, bipolar disorder,mental retardation, pervasive developmental disorder, delirium, dementia, cognitiveimpairment, alcohol dependence, etc

  • Suffering from serious organic diseases, such as diabetes, thyroid disease,hypertension, cardiovascular disease, craniocerebral trauma, cerebral ischemia orhemorrhage;

  • 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 orindividuals who are overly agitated Pregnant or lactating women, or those planningto conceive in the near future;

  • Laboratory tests indicate the presence of liver and kidney function impairment inindividuals;

  • There are other individuals who meet the relevant contraindications forantidepressants.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Citalopram hydrobromide combined with zolpidem
Phase: 4
Study Start date:
January 01, 2025
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Tongji University

    Shanghai, Shanghai 200124
    China

    Active - Recruiting

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