A Study of Mianserin in Combination With SSRIs in Depression With Sleep Problems

Launched by ZHENGHUI YI · Oct 26, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how effective a medication called mianserin is when combined with an antidepressant called escitalopram for treating depression in patients who also have sleep problems. The trial aims to find out if this combination can help improve not just mood, but also sleep quality and cognitive function, compared to another treatment that combines lorazepam (a medication often used for anxiety and sleep issues) with escitalopram. The study will involve 100 participants aged between 18 and 60 years who are diagnosed with major depressive disorder and have sleep difficulties.

To participate, individuals must have a certain level of depression and sleep issues as measured by specific scoring systems. They should not have taken any antidepressants or sleep medications in the two weeks prior to the study and must be able to understand the study and agree to participate. Throughout the trial, participants will be monitored over eight weeks to see how well each treatment works and to ensure that it is safe. This research hopes to provide valuable information that can help guide treatment options for people dealing with depression and sleep problems.

Gender

ALL

Eligibility 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.