Depressed Insomniac Co-morbid PatientsPhase 4n-REMSSNCT06740188
Trazodone on NREM Sleep Stage Ⅲ in Depressed Insomniac Co-morbid Patients
A Phase 4 study testing 5-hydroxytryptamine balanced antidepressants trazodone and Citalopram hydrobromide combined with zolpidem in people with Depressed Insomniac Co-morbid Patients, run by Tongji University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressed Insomniac Co-morbid Patients
- What is being tested?
- 5-hydroxytryptamine balanced antidepressants trazodone and Citalopram hydrobromide combined with zolpidem
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji University
Shanghai, Shanghai Municipality, 200124
Meiling Liu, PhD., +86-13917639849, tongjie_room@126.com
About this study
Official title: Impact of Trazodone on Non-rapid Eye Movement Sleep Stage Ⅲ in Depressed Insomniac Co-morbid Patients: A Randomized Controlled Trial
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
- Being tested
- 5-hydroxytryptamine balanced antidepressants trazodone, Citalopram hydrobromide combined with zolpidem
- Keywords
- Trazodone, Non-rapid Eye Movement Sleep Stage, depression, insomnia
- Medical subject headings
- Depression, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-hydroxytryptamine balanced antidepressants trazodoneDrug
The intervention group was given only 5-hydroxytryptamine balanced antidepressants trazodone
Citalopram hydrobromide combined with zolpidemDrug
the control group was given citalopram hydrobromide combined with zolpidem
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group was given only 5-hydroxytryptamine balanced antidepressants trazodone. Receives: Drug: 5-hydroxytryptamine balanced antidepressants trazodone |
| Control group | Active comparator | The control group was given citalopram hydrobromide combined with zolpidem. Receives: Drug: Citalopram hydrobromide combined with zolpidem |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Baseline and 1 week after medication
Secondary outcomes (6)
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.
Measured: baseline, 1, 2, and 4 weeks after medication
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, 1, 2, and 4 weeks after medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Depressed Insomniac Co-morbid PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Tong, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740188
- Sponsor's protocol ID
- PWRq2024-21
- Acronym
- n-REMSS
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 19151617Sheehan 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.
PubMed 20581790Sheehan 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.
PubMed 19724732Roth 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.
PubMed 21623982Jarema 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.
PubMed 22232986Collins 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.
PubMed 21734685
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Trazodone on Non-rapid Eye Movement Sleep Stage Ⅲ in Depressed Insomniac Co-morbid Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06740188
- Acronym / sponsor ID
- n-REMSS / PWRq2024-21
- Conditions
- Depressed Insomniac Co-morbid Patients
- Keywords
- Trazodone, Non-rapid Eye Movement Sleep Stage, depression, insomnia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tongji UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: 5-hydroxytryptamine balanced antidepressants trazodoneThe intervention group was given only 5-hydroxytryptamine balanced antidepressants trazodone. |
| Control group | Active comparator | Drug: Citalopram hydrobromide combined with zolpidemThe control group was given citalopram hydrobromide combined with zolpidem. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-hydroxytryptamine balanced antidepressants trazodoneThe intervention group was given only 5-hydroxytryptamine balanced antidepressants trazodone | Drug | Intervention group |
| Citalopram hydrobromide combined with zolpidemthe control group was given citalopram hydrobromide combined with zolpidem | Drug | Control group |
Primary outcome
Sleep structure staging
Time frame: Baseline and 1 week after medication
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%.
6 secondary outcomes
The 17 item Hamilton Depression Scale (HAMD-17)
Time frame: baseline, 1, 2, and 4 weeks after medication
Zong's Self rating Depression Scale (SDS)
Time frame: baseline, 1, 2, and 4 weeks after medication
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: baseline, 1, 2, and 4 weeks after medication
The Athens Insomnia Scale (AIS)
Time frame: baseline, 1, 2, and 4 weeks after medication
The Antidepressant Side Effect Checklist (ASEC)
Time frame: baseline, 1, 2, and 4 weeks after medication
Drug Dependence Scale (DDS)
Time frame: baseline, 1, 2, and 4 weeks after medication
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Results publication: PubMed 19151617Geyer 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.
- Results publication: PubMed 20581790Sheehan 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.
- Results publication: PubMed 19724732Sheehan 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.
- Results publication: PubMed 21623982Roth 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.
- Results publication: PubMed 22232986Jarema 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.
- Results publication: PubMed 21734685Collins 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.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 5-hydroxytryptamine balanced antidepressants trazodone and Citalopram hydrobromide combined with zolpidem in people with Depressed Insomniac Co-morbid Patients, run by Tongji University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meiling Liu, M.M. (86+2168306699, tongjie_room@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep structure staging (time frame: Baseline and 1 week after medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06740188, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.