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

NCT ID: NCT05599126

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-12-30

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Mianserin with escitalopram

Group Type: EXPERIMENTAL

Mianserin

Intervention Type: DRUG

Subjects were required to take mianserin regularly during the study period, with the effective dose being taken orally once a night before bedtime.

Lorazepam with escitalopram

Group Type: ACTIVE_COMPARATOR

Lorazepam

Intervention Type: DRUG

Subjects were required to take lorazepam regularly during the study period, with the effective dose being taken orally once a night before bedtime.

Interventions

Mianserin

Subjects were required to take mianserin regularly during the study period, with the effective dose being taken orally once a night before bedtime.

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Renhe Tang Pharmaceutical Co.

UNKNOWN

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

Brain Hospital of Guangzhou Medical University

UNKNOWN

Sponsor Role: collaborator

Zhenghui YI

OTHER

Sponsor Role: lead

Responsible Party

Zhenghui YI

Director of Clinical Section VIII

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Shanghai Mental Health Center

Shanghai, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Zhenghui Yi, M.D

Role: primary

yizhenghui1971@163.com

18017311007

Other Identifiers

2021-TX-002

Identifier Type: -

Identifier Source: org_study_id