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

Phase 4

Recruiting

• Conditions: Depression
• Interventions: Drug: Mianserin; Drug: Lorazepam

• Registration Number: NCT05599126
• Lead Sponsor: Zhenghui YI

Brief Summary

Patients with depression with sleep problems have functional abnormalities of 5-HT and NE neurotransmitters, and the NaSSA class antidepressant mianserin has an ameliorative effect on sleep problems along with antidepressant. However, whether mianserin can improve cognitive function in patients still needs to be explored. The benzodiazepine lorazepam can play a central inhibitory role and has good therapeutic effect on insomnia. The mechanism of action of mianserin and lorazepam is different, and there are few comparative studies related to the combination of the two with SSRI drugs for the treatment of depressed patients with sleep problems, and it is unclear whether there are differences in their efficacy and safety. Therefore, to address the above scientific questions, this study was designed to include 100 patients aged 18-60 years with depression with sleep problems, randomly divided into two groups and treated with mianserin + escitalopram or lorazepam + escitalopram, respectively, and followed up for 8 weeks to assess depression and anxiety symptoms, sleep, cognitive function and drug safety. To compare the efficacy and safety of the two regimens in depressed patients with sleep problems and to provide a scientific basis for clinical intervention in depressed patients with sleep problems.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-10-26
• Study First Posted: 2022-10-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-27
• Study Start: 2024-07-01
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mianserin with escitalopram	Mianserin	-
Lorazepam with escitalopram	Lorazepam	-

Primary Outcome Measures

Name	Time	Method
Pittsburgh sleep quality index,PSQI	8 weeks	30% reduction in the PSQI scale.

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, China