Trial reportCNS drugs2025
Efficacy and Safety of Escitalopram Combined with Tandospirone Citrate in Treating Patients with Vascular Depression and Chronic Insomnia: A Randomized Controlled Trial.
Trial report in CNS drugs, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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9 authors.
Funding
Abstract
BACKGROUND AND
objectiveChronic sleeplessness is a primary clinical symptom of vascular depression (VaDep). We investigated the efficacy and safety of escitalopram plus tandospirone citrate for patients with VaDep and chronic insomnia and the potential correlation of insomnia severity with neurotransmitter indexes, including serotonin (5-HT), serotonin 2C receptor (5-HT
methodsThis double-blind, randomized controlled study randomized patients with VaDep and chronic insomnia [Hamilton depression rating scale (HAMD) > 17 points] into a monotherapy group [escitalopram (10 mg once daily) plus placebo] or combined group [escitalopram (10 mg once daily) plus tandospirone citrate (10 mg three times daily)] by using a 1:1 assignment algorithm generated by SPSS 25.0 software. The primary endpoint was the change in sleep quality from baseline to week 12, evaluated by the Pittsburgh Sleep Quality Index (PSQI), polysomnography (PSG), Epworth Sleepiness Scale, and Asen Self-Rating Insomnia Scale (AIS). Secondary outcomes were the changes in depression and anxiety assessment and the levels of peripheral blood neurotransmitters from baseline to week 12, including HAMD, the Hamilton anxiety scale (HAMA), 5-HT, 5-HT
resultsA total of 123 subjects (30.89% male) were included, with a mean age of 70.56 ± 6.37 (mean ± standard deviation, SD) years. In the monotherapy group, the baseline HAMD and PSQI scores (n = 61 for both) were 28.84 ± 2.49 and 14.16 ± 1.86, respectively. In the combined group, the baseline HAMD and PSQI scores (n = 62 for both) were 28.81 ± 2.51 and 14.21 ± 1.87, respectively. The HAMA and HAMD scores in both groups were significantly lower at weeks 4, 8, and 12 after treatment than before treatment (P < 0.001). Compared with the monotherapy counterpart, the combined group displayed significantly lower PSQI and AIS scores at weeks 4, 8, and 12 and improved PSG sleep macrostructure at week 12, including total sleep time (TST), sleep latency, sleep efficiency, sleep maintenance rate (SMT), wake time after sleep onset, and percentage of sleep in each phase. Platelet 5-HT, plasma 5-HT, and platelet 5-HT
conclusionsThe statistically significant changes in PSG, PSQI, and AIS may indicate that the combination of escitalopram and tandospirone may improve, with a reasonable safety profile, the sleep quality of patients with VaDe. The clinical results observed were associated with changes in measures of plasma 5-HT and platelet 5HT CLINICAL TRIAL REGISTRY NUMBER: ChiCTR2300075407.
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