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

NCT06740188 | Recruiting Phase 4

• 1 other identifier: PWRq2024-21
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressed Insomniac Co-morbid Patients

Keywords

Trazodone; Non-rapid Eye Movement Sleep Stage; depression; insomnia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• The 17 item Hamilton Depression Scale (HAMD-17)

  baseline, 1, 2, and 4 weeks after medication

• Zong's Self rating Depression Scale (SDS)

  baseline, 1, 2, and 4 weeks after medication

• The Pittsburgh Sleep Quality Index (PSQI)

  baseline, 1, 2, and 4 weeks after medication

• The Athens Insomnia Scale (AIS)

  baseline, 1, 2, and 4 weeks after medication

• The Antidepressant Side Effect Checklist (ASEC)

  baseline, 1, 2, and 4 weeks after medication

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group was given only 5-hydroxytryptamine balanced antidepressants trazodone.

Drug: 5-hydroxytryptamine balanced antidepressants trazodone

Control group

ACTIVE COMPARATOR

The control group was given citalopram hydrobromide combined with zolpidem.

Drug: Citalopram hydrobromide combined with zolpidem

Interventions

5-hydroxytryptamine balanced antidepressants trazodone DRUG

The intervention group was given only 5-hydroxytryptamine balanced antidepressants trazodone

Intervention group

Citalopram hydrobromide combined with zolpidem DRUG

the control group was given citalopram hydrobromide combined with zolpidem

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatient or inpatient patients;
• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji University: lead

Study Sites (1)

Tongji University

Shanghai, Shanghai Municipality, 200124, China

RECRUITING

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 21734685 BACKGROUND

MeSH Terms

Conditions

Depression; Sleep Initiation and Maintenance Disorders

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Meiling Liu, M.M.

CONTACT

86+2168306699; tongjie_room@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 18, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 19, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)