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

Last updated: June 25, 2024
Sponsor: Zhenghui YI
Overall Status: Active - Recruiting

Phase

4

Condition

Narcolepsy

Depression

Sleep Disorders

Treatment

Lorazepam

Mianserin

Clinical Study ID

NCT05599126
2021-TX-002
  • Ages 18-60
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meeting the diagnostic criteria for major depressive disorder (DSM-5) with a HAMD-17score ≥ 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

Exclusion Criteria:

  • DSM-5 organic mood disorders; psychiatric disorders associated with somaticdiseases; 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 unableto understand the content of the scale

  • Pregnant and lactating females.

  • Those who cannot cooperate with the experimental procedure and cannot cooperateeffectively.

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Lorazepam
Phase: 4
Study Start date:
July 01, 2024
Estimated Completion Date:
December 30, 2025

Connect with a study center

  • Shanghai Mental Health Center

    Shanghai,
    China

    Active - Recruiting

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