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

A Multicenter Open Study of the Efficacy of Mianserin in Combination With SSRIs in Patients With Depression With Sleep Problems

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.

Study Overview

• Status: Recruiting
• Conditions: Depression
• Intervention / Treatment: Drug: Mianserin; Drug: Lorazepam

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai Mental Health Center
    • Contact: Zhenghui Yi, M.D; Phone Number: 18017311007; Email: yizhenghui1971@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mianserin with escitalopram	Drug: Mianserin; Subjects were required to take mianserin regularly during the study period, with the effective dose being taken orally once a night before bedtime.
Active Comparator: Lorazepam with escitalopram	Drug: Lorazepam; Subjects were required to take lorazepam regularly during the study period, with the effective dose being taken orally once a night before bedtime.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh sleep quality index,PSQI	30% reduction in the PSQI scale.	8 weeks

Collaborators and Investigators

• Sponsor: Zhenghui YI
• Collaborators: Renhe Tang Pharmaceutical Co.; Nantong Mental Health Centre (Nantong Fourth People's Hospital); Brain Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Nervous System Diseases; Mood Disorders; Sleep Wake Disorders; Depression; Depressive Disorder; Dyssomnias; Parasomnias; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Serotonin Antagonists; Hypnotics and Sedatives; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anticonvulsants; Antidepressive Agents, Second-Generation; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Adrenergic alpha-Antagonists; Lorazepam; Mianserin
• Other Study ID Numbers: 2021-TX-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No