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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05599126
• Other study ID #: 2021-TX-002
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 2022
• Est. completion date: December 2023

Study information

• Verified date: October 2022
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 1) Meeting the diagnostic criteria for major depressive disorder (DSM-5) with a HAMD-17 score = 17 and a HAMA score = 14.

2) having complaints of sleep problems or PSQI scores >7. Han Chinese, age 18-60 years old, junior high school education or above. 4) no previous manic episodes or manifestations of mild manic episodes. 5) not taking antidepressants and sedative-hypnotic drugs in the last 2 weeks, or a 7-day cleansing period for those taking drugs.

6)no use of convulsion-free electroconvulsive therapy (MECT) within 8 weeks 7) Those who voluntarily participated in the study with the patient's informed consent.

Exclusion Criteria:

• 1) DSM-5 organic mood disorders; psychiatric disorders associated with somatic diseases; psychiatric disorders due to psychoactive substances.

2) Those with contraindications to escitalopram, mianserin, lorazepam medications.

3) family history of psychiatric or other somatic disorders. 4)Those with excessive psychiatric symptoms unable to complete the interview or unable to understand the content of the scale 5)Pregnant and lactating females. 6) Those who cannot cooperate with the experimental procedure and cannot cooperate effectively.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Dyssomnias
• Parasomnias

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Zhenghui YI

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pittsburgh sleep quality index,PSQI	30% reduction in the PSQI scale.	8 weeks