A Study of Mianserin in Combination With SSRIs in Depression With Sleep Problems
Status:
Not yet recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
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.