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

NCT05599126 | Recruiting Phase 4 DMC

• 1 other identifier: 2021-TX-002
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pittsburgh sleep quality index,PSQI

  30% reduction in the PSQI scale.

  8 weeks

Study Arms (2)

Mianserin with escitalopram

EXPERIMENTAL

Drug: Mianserin

Lorazepam with escitalopram

ACTIVE COMPARATOR

Drug: Lorazepam

Interventions

Mianserin DRUG

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

Mianserin with escitalopram

Lorazepam DRUG

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

Lorazepam with escitalopram

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Mental Health Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Mianserin; Lorazepam

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Clinical Section VIII

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: October 31, 2022
• Study Start: July 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 30, 2025
• Last Updated: June 27, 2024

Record last verified: 2024-06

Locations

CN (1)