Combining Mianserin and SSRIs for Depression with Sleep Issues
A Multicenter Open Study of the Efficacy of Mianserin in Combination With SSRIs in Patients With Depression With Sleep Problems
This study is testing whether combining mianserin with escitalopram can help people with depression and sleep problems feel better compared to taking lorazepam with escitalopram.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Shanghai Mental Health Center Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05599126 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of mianserin, a NaSSA class antidepressant, in combination with escitalopram, an SSRI, on patients suffering from depression and sleep problems. It aims to compare the efficacy and safety of this combination against lorazepam plus escitalopram in a randomized trial involving 100 participants aged 18-60. The study focuses on patients with major depressive disorder who also experience sleep disturbances, assessing cognitive function improvements alongside mood stabilization. The research seeks to clarify the potential benefits of these treatment combinations for enhancing patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are Han Chinese individuals aged 18-60 with major depressive disorder and significant sleep issues.
Not a fit: Patients with organic mood disorders or those contraindicated for the study medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with depression and sleep problems.
How similar studies have performed: While there are few comparative studies on this specific combination, the approach of combining different classes of antidepressants has shown promise in other research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Meeting the diagnostic criteria for major depressive disorder (DSM-5) with a HAMD-17 score ≥ 17 and a HAMA score ≥ 14. * Having complaints of sleep problems or PSQI scores \>7. * Han Chinese, age 18-60 years old, junior high school education or above. * No previous manic episodes or manifestations of mild manic episodes. * Not taking antidepressants and sedative-hypnotic drugs in the last 2 weeks, or a 7-day cleansing period for those taking drugs. * No use of convulsion-free electroconvulsive therapy (MECT) within 8 weeks * Those who voluntarily participated in the study with the patient's informed consent. Exclusion Criteria: * DSM-5 organic mood disorders; psychiatric disorders associated with somatic diseases; psychiatric disorders due to psychoactive substances. * Those with contraindications to escitalopram, mianserin, lorazepam medications. * family history of psychiatric or other somatic disorders. * Those with excessive psychiatric symptoms unable to complete the interview or unable to understand the content of the scale * Pregnant and lactating females. * Those who cannot cooperate with the experimental procedure and cannot cooperate effectively.
Where this trial is running
Shanghai
- Shanghai Mental Health Center — Shanghai, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.