Trazodone for Depression and Insomnia
Trazodone on NREM Sleep Stage Ⅲ in Depressed Insomniac Co-morbid Patients
Recruiting
Phase 4
Interventional Study
Depressed Insomniac Co-morbid Patients
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 60 (estimated)
- Sponsor
- Tongji University · Other
Who this trial is looking for
This trial is looking for adults with depression and insomnia. Participants will take either trazodone or another antidepressant for a few weeks and answer questions about their sleep and mood.
Are You a Good Fit for This Trial?
You may be able to join if
- I am between 18 and 65 years old.
- I have been diagnosed with depression and non-organic insomnia.
- I have a Hamilton Depression score of 17 or higher.
- I have a Pittsburgh Sleep Quality Index score of 16 or higher.
- I have not used antidepressants or sedatives before.
- I can understand and complete questionnaires on my own.
- I have at least a primary school education.
- I can give my written consent to join the trial.
You may not be able to join if
- I have a serious mental illness like schizophrenia or bipolar disorder.
- I have a serious medical condition like diabetes or heart disease.
- I have narrow-angle glaucoma.
- I have a history of epilepsy or seizures.
- I have used drugs before.
- I have tested positive for syphilis or AIDS.
- I am pregnant, breastfeeding, or planning to get pregnant soon.
- My liver or kidney tests aren't normal.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This 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…
Trial Locations
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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 …
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