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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | The intervention group was given only 5-hydroxytryptamine balanced antidepressants trazodone. |
|
| Control group | Active Comparator | The control group was given citalopram hydrobromide combined with zolpidem. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-hydroxytryptamine balanced antidepressants trazodone | Drug | The intervention group was given only 5-hydroxytryptamine balanced antidepressants trazodone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep structure staging | 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%. | Baseline and 1 week after medication |
| Measure | Description | Time Frame |
|---|---|---|
| The 17 item Hamilton Depression Scale (HAMD-17) | 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. | baseline, 1, 2, and 4 weeks after medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meiling Liu, M.M. | Contact | 86+2168306699 | tongjie_room@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji University | Recruiting | Shanghai | Shanghai Municipality | 200124 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19151617 | Result | 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. | |
| 20581790 | Result | 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. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
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| ID | Term |
|---|---|
| D000077334 | Zolpidem |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Citalopram hydrobromide combined with zolpidem | Drug | the control group was given citalopram hydrobromide combined with zolpidem |
|
| Zong's Self rating Depression Scale (SDS) | 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. | baseline, 1, 2, and 4 weeks after medication |
| The Pittsburgh Sleep Quality Index (PSQI) | 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. | baseline, 1, 2, and 4 weeks after medication |
| The Athens Insomnia Scale (AIS) | 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. | baseline, 1, 2, and 4 weeks after medication |
| The Antidepressant Side Effect Checklist (ASEC) | 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. | baseline, 1, 2, and 4 weeks after medication |
| Drug Dependence Scale (DDS) | 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. | baseline, 1, 2, and 4 weeks after medication |
| 19724732 | Result | 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. |
| 21623982 | Result | 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. |
| 22232986 | Result | 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. |
| 21734685 | Result | 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. |
| D012893 |
| Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |