Clinical TrialDepressive DisordersNot yet recruiting

Effect of Esketamine on Cognitive Behavioral Therapy for Insomnia Adherence in Patients with Comorbid Insomnia and Depression

This retrospective cohort study in China (n=184; exposure group 92, control group 92) examined the effect of esketamine on adherence to cognitive behavioural therapy for insomnia (CBT-I) in patients with comorbid insomnia and depression. The study compared an exposure group and a control group, although no active intervention was administered in either group, consistent with the observational design. The primary outcome was adherence to behavioural strategies, with assessment of whether esketamine exposure was associated with better engagement in CBT-I. Secondary outcomes included bedtime variability, wake-up time variability, CBT-I completion rate, Insomnia Severity Index scores, response and remission rates, Hospital Anxiety and Depression Scale scores, and equivalent benzodiazepine dose. The trial included adults aged 18 to 75 years and was sponsored by Shanghai Fourth People’s Hospital. As a retrospective study, the protocol did not specify a treatment phase or prospective dosing schedule, and outcome timepoints were not detailed in the source record.

Target Enrollment
Not specified
Study Type
observational
Design
Non-randomized

Participants

Ages
1875
Sexes
Male & Female

Inclusion Criteria

  • Inclusion criteria: 1. Aged 18-75 years;2. Received treatment for sleep problems at the Department of Sleep Medicine, Shanghai Fourth People's Hospital between February 2022 and February 2025.3. Diagnosed with insomnia disorder according to ICSD-3 criteria.4. Diagnosed with major depressive disorder according to DSM-5 criteria.5. Insomnia Severity Index (ISI) score >7 and Hospital Anxiety and Depression Scale-Depression (HADS-D) subscore >10.6. Underwent treatment with either combined esketamine and CBT-I or CBT-I alone.7. Availability of complete baseline data of interest.

Exclusion Criteria

  • Exclusion criteria: 1. Diagnosis of schizophrenia, bipolar disorder, recurrent panic attacks, or active suicidality.2. Presence of dysarthria, hearing impairment, or cognitive dysfunction.3. Other types of sleep disorders, such as sleep apnea, restless legs syndrome, or sleep-related movement disorders.4. Receipt of other interventional treatments.

Study Details

  • Status
    Not yet recruiting
  • Type
    observational
  • Design
    Non-randomized
  • Timeline
    Start: 2025-11-30
  • Topic

Study Team

Sponsors & Collaborators

Locations

China

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