MedTrace Logo

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

NCT05599126 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-06-27

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Renhe Tang Pharmaceutical Co.

    collaborator UNKNOWN

  • Nantong Mental Health Centre (Nantong Fourth People's Hospital)

    collaborator UNKNOWN

  • Brain Hospital of Guangzhou Medical University

    collaborator UNKNOWN

  • Zhenghui YI

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2025-12-01
Completion
2025-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05599126 on ClinicalTrials.gov