Recurrent depression, insomnia
Conditions
Interventions
Control Group:Eszopiclone Tablets combined with escitalopram oxalate for the treatment of insomnia symptoms in patients with recurrent depression
Experimental Group:Dimdazenil combined with escitalopram oxalate for the treatment of insomnia symptoms in patients with recurrent depression
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1)Have a full understanding of this study and voluntarily sign the informed consent form; 2)Aged 18 to 65 years old, regardless of gender; 3)Meet the diagnostic criteria for insomnia disorder or other specified insomnia disorder (short-term insomnia disorder) as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V); 4)Experience insomnia symptoms (total sleep time = 53 on the Zung Self-Rating Depression Scale (SDS); 7)Be able to ensure a sleep opportunity of at least 7 hours; 8)Have the ability to read, complete scales and sleep diaries; 9)Currently using or planning to use escitalopram oxalate for antidepressant treatment.
Exclusion criteria
Exclusion criteria: 1)Have other mental disorders (such as schizophrenia, bipolar disorder, etc.) that meet the diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), except for insomnia disorder, other specified insomnia disorder (short-term insomnia disorder), and depressive disorder; 2)Have received benzodiazepine receptor agonist treatment within 1 week before enrollment in the study; 3)Have a history of ineffective treatment of insomnia with eszopiclone; 4)Have received physical therapy (such as transcranial magnetic stimulation, transcranial direct current stimulation) or psychological therapy (including but not limited to cognitive behavioral therapy, etc.) within 1 week before enrollment in the study; 5)Have depressive disorder with "psychotic features" and require inpatient treatment; 6)Have a history of allergy to any component of escitalopram oxalate tablets, dimdazenil capsules, or eszopiclone tablets; 7)Currently have unstable physical diseases, or conditions that may affect the safety of the trial and are deemed unsuitable for participation by the researcher; 8)Have severe obstructive sleep apnea, respiratory insufficiency, myasthenia gravis, or other similar diseases; 9)Have a history of epilepsy, developmental delay, cognitive impairment, alcoholism, or drug abuse; 10)Women with recent plans for pregnancy, or those who are pregnant or lactating; 11)Other circumstances deemed unsuitable for participation in this clinical study by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| insomnia severity index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep Wake After Sleep Onset (sWASO);Number of Awake (sNAW);Depression Self-Rating Score (SDS);Flinders Fatigue Scale (FFS);subjective sleep latency;Epworth Sleepiness Scale (ESS);subjective total sleep time (sTST);sleep effecacy; | — |
Countries
China
Contacts
Public ContactHONG CHEN
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed