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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 5-hydroxytryptamine balanced antidepressants trazodone
  The intervention group was given only 5-hydroxytryptamine balanced antidepressants trazodone
• Препарат Citalopram hydrobromide combined with zolpidem
  the control group was given citalopram hydrobromide combined with zolpidem

Первичные конечные точки

• Sleep structure staging [Срок оценки: Baseline and 1 week after medication]

Вторичные конечные точки (6)

• The 17 item Hamilton Depression Scale (HAMD-17) [Срок оценки: baseline, 1, 2, and 4 weeks after medication]
• Zong's Self rating Depression Scale (SDS) [Срок оценки: baseline, 1, 2, and 4 weeks after medication]
• The Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: baseline, 1, 2, and 4 weeks after medication]
• The Athens Insomnia Scale (AIS) [Срок оценки: baseline, 1, 2, and 4 weeks after medication]
• The Antidepressant Side Effect Checklist (ASEC) [Срок оценки: baseline, 1, 2, and 4 weeks after medication]
• Drug Dependence Scale (DDS) [Срок оценки: baseline, 1, 2, and 4 weeks after medication]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Tongji University — Шанхай

Публикации

• Geyer JD, Carney PR, Dillard SC, Davis L, Ward LC. Antidepressant medications, neuroleptics, and prominent eye movements during NREM sleep. J Clin Neurophysiol. 2009 Feb;26(1):39-44. doi: 10.1097/WNP.0b013e318196046f. PMID 19151617
• Sheehan DV, Rozova A, Gossen ER, Gibertini M. The efficacy and tolerability of once-daily controlled-release trazodone for depressed mood, anxiety, insomnia, and suicidality in major depressive disorder. Psychopharmacol Bull. 2009;42(4):5-22. PMID 20581790
• Sheehan DV, Croft HA, Gossen ER, Levitt RJ, Brulle C, Bouchard S, Rozova A. Extended-release Trazodone in Major Depressive Disorder: A Randomized, Double-blind, Placebo-controlled Study. Psychiatry (Edgmont). 2009 May;6(5):20-33. PMID 19724732
• Roth AJ, McCall WV, Liguori A. Cognitive, psychomotor and polysomnographic effects of trazodone in primary insomniacs. J Sleep Res. 2011 Dec;20(4):552-8. doi: 10.1111/j.1365-2869.2011.00928.x. Epub 2011 May 30. PMID 21623982
• Jarema M, Dudek D, Landowski J, Heitzman J, Rabe-Jablonska J, Rybakowski J. [Trazodon--the antidepressant: mechanism of action and its position in the treatment of depression]. Psychiatr Pol. 2011 Jul-Aug;45(4):611-25. Polish. PMID 22232986
• Collins PY, Patel V, Joestl SS, March D, Insel TR, Daar AS; Scientific Advisory Board and the Executive Committee of the Grand Challenges on Global Mental Health; Anderson W, Dhansay MA, Phillips A, Shurin S, Walport M, Ewart W, Savill SJ, Bordin IA, Costello EJ, Durkin M, Fairburn C, Glass RI, Hall W, Huang Y, Hyman SE, Jamison K, Kaaya S, Kapur S, Kleinman A, Ogunniyi A, Otero-Ojeda A, Poo MM, R PMID 21734685

Идентификаторы

NCT: NCT06740188 · PWRq2024-21

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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