Major depressive disorder with insomnia
Conditions
Interventions
Experimental group:Escitalopram + Lemborexant
Control group:Escitalopram + placebo
Sponsors
Peking University Sixth Hospital ( Institute of Mental Health )
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1.At the time of signing the informed consent form, aged >=18 years and 17 points, with a total score of >=3 points in the sleep items; 4.Meets the diagnostic criteria for chronic insomnia in the DSM-5. Insomnia symptoms occur on >=3 nights per week over the past 3 months: total sleep time (sTST) =60 minutes, with or without sleep onset latency (sSOL) >=30 minutes; 5.Score on the Insomnia Severity Index (ISI) >=15 points, and a score of >=2 points on Item 5 (daytime function) of the ISI; 6.able to ensure >=7 hours of time in bed each night;
Exclusion criteria
Exclusion criteria: 1.Judged by researchers to meet the diagnostic criteria for other mental disorders in the DSM-5 (schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, obsessive-compulsive and related disorders, somatic symptom disorders, and other mental disorders); 2.Determined by researchers to meet the diagnostic criteria for major depressive disorder with psychotic features in DSM-5; 3.Currently at risk of suicide, or with a score of >=3 on item 3 (suicide score) of the HAMD-17 scale, or having answered "yes" to item 3, 4, or 5 regarding suicidal ideation in the C-SSRS within the past 6 months, or having a history of suicidal behavior within 1 year; 4.Refractory depression (previous or current use of 2 or more antidepressants with different chemical structures, with ineffective or minimal response after adequate dose and duration of treatment); 5.Having contraindications to lemborexant, such as narcoleps; 6.Comorbid with other sleep disorders (such as sleep apnea, periodic limb movement disorder, etc.); 7.Judged by researchers to have severe or unstable diseases of the cardiovascular, liver, kidney, or other systems or organs; 8.Having received escitalopram treatment for >=2 weeks during the current episode, or having received antidepressant treatment other than escitalopram during the current episode; 9.Unable to discontinue other sedative-hypnotic drugs and drugs known to significantly affect sleep during treatment, or having not stopped taking such drugs for 5 half-lives before starting the study treatment; 10.Psychotherapy cannot be discontinued during treatment, such as Cognitive Behavioral Therapy (CBT); 11.Having a habitual bedtime earlier than 21:00 or later than 01:00 more than 2 times a week, or a habitual wake-up time later than 09:00 more than 2 times a week; 12.Having a history of alcohol abuse within 6 months before enrollment; 13.Currently taking or planning to take moderate/strong inducers or inhibitors of CYP3A4 during the study period; 14.Pregnant or lactating women; 15.Having a severe hypersensitive constitution, being allergic to at least 2 or more classes of drugs, or known to be allergic to the components or excipients of the study drug; 16.Subjects judged by researchers to be unsuitable for participating in this trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective Total Sleep Time; | — |
Secondary
| Measure | Time frame |
|---|---|
| subjective sleep onset latency (sSOL);subjective sleep efficiency (sSE);Objective Sleep Latency (LPS);Change value of HAMD-17 total score (excluding sleep factor);ISI Scale Assessment;Change value of Fatigue Severity Scale (FSS) score;Change value of the total score of the Insomnia Severity Index (ISI);Change value of subjective wake after sleep onset (sWASO);Change value of objective sleep efficiency (SE);Patient Global Impression of Improvement (PGI-I) score;Rebound of subjective sleep indicators after drug withdrawal;Objective change value of wake after sleep onset (WASO);Change in score of Hamilton Anxiety Scale (HAMA) (excluding insomnia item);Clinical Global Impression - Improvement Scale (CGI-I) Score;Subjective Total Sleep Time;Change from Baseline in Clinical Global Impressions-Severity Scale (CGI-S) Score; | — |
Countries
China
Contacts
Public ContactLin Lu
Peking University Sixth Hospital ( Institute of Mental Health )
Outcome results
None listed