Clinical trial NCT06740188: Trazodone on NREM Sleep Stage Ⅲ in Depressed Insomniac Co-morbid Patients
Official title: Impact of Trazodone on Non-rapid Eye Movement Sleep Stage Ⅲ in Depressed Insomniac Co-morbid Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Depressed Insomniac Co-morbid Patients
Keywords: Trazodone
Non-rapid Eye Movement Sleep Stage
depression
insomnia
Lead sponsor: Tongji University
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Sleep structure staging
timeFrame: Baseline and 1 week after medication
Secondary outcomes:
measure: The 17 item Hamilton Depression Scale (HAMD-17)
timeFrame: baseline, 1, 2, and 4 weeks after medication
measure: Zong's Self rating Depression Scale (SDS)
timeFrame: baseline, 1, 2, and 4 weeks after medication
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: baseline, 1, 2, and 4 weeks after medication
measure: The Athens Insomnia Scale (AIS)
timeFrame: baseline, 1, 2, and 4 weeks after medication
measure: The Antidepressant Side Effect Checklist (ASEC)
timeFrame: baseline, 1, 2, and 4 weeks after medication
measure: Drug Dependence Scale (DDS)
timeFrame: baseline, 1, 2, and 4 weeks after medication
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Tongji University
state: Shanghai
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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, Ravindranath V, Sahakian BJ, Saxena S, Singer PA, Stein DJ. Grand challenges in global mental health. Nature. 2011 Jul 6;475(7354):27-30. doi: 10.1038/475027a. No abstract available.