Table 4 The effect of trazodone on daytime impairment symptoms by domain and ontology

Endpoint Ontology	Number of daytime impairment symptoms [events per 100 patient years]^a			Percentage increase in endpoint after treatment ± SD (P-value)^b
Endpoint Ontology	Before treatment	During treatment	Average treatment effect [95% CI]
All domains
ICD-clin	12.6	19.4	6.8 [−0.0, 13.5]	53.5% ± 134.7% (P = 0.014)
ICD-clin-DiSMOL	69.6	91.8	16.4 [−1.3, 34.1]	32.0% ± 351.9% (P < 0.001)
DiSMOL	137.7	150.1	12.4 [−7.4, 32.1]	9.0% ± 392.7% (P = 0.094 [ns])
Cognition domain
ICD-clin	12.6	19.4	6.8 [−0.0, 13.5]	53.5% ± 134.7% (P = 0.014)
ICD-clin-DiSMOL	34.9	43.4	6.4 [−3.6, 16.3]	24.3% ± 198.5% (P = 0.037)
DiSMOL	95.1	99.4	4.2 [−10.2, 18.6]	4.4% ± 286.1% (P = 0.465 [ns])
Emotional domain
ICD-clin	12.3	18.4	6.1 [−0.6, 12.8]	49.9% ± 134.0% (P = 0.018)
ICD-clin-DiSMOL	43.0	58.0	9.2 [−5.6, 24.1]	35.1% ± 295.4% (P = 0.002)
DiSMOL	87.1	98.3	11.2 [−4.8, 27.2]	12.9% ± 317.6% (P = 0.071 [ns])
Physical domain
ICD-clin	12.5	18.8	6.3 [−0.5, 13.0]	50.1% ± 134.4% (P = 0.018)
ICD-clin-DiSMOL	19.1	24.4	5.3 [−2.6, 13.2]	27.8% ± 157.8% (P = 0.072 [ns])
DiSMOL	110.8	118.6	7.7 [−9.1, 24.6]	7.0% ± 334.5% (P = 0.237 [ns])

Trazodone did not demonstrate statistically significant changes across any domain (P-values ≥ 0.071) when using the DiSMOL method. However, when assessed using ICD-clin and ICD-clin-DiSMOL, trazodone was associated with a statistically significant increase in daytime impairment symptoms across the all domains, cognition domain, emotional domain, and physical domain categories. Notably, the observed increase in daytime impairment may be overestimated when relying on ICD-clin and ICD-clin-DiSMOL.
CI confidence interval, DiSMOL Disease-Specific Medical Ontology Learning, ICD International Classification of Diseases, ns not significant, SD standard deviation.
^aThe follow up period was from 182 days before treatment to approximately 3 months (mean) during treatment.
^bAn increase shows worsening of daytime functioning (more daytime impairment symptoms) after treatment compared with before treatment, while a decrease shows an improvement in daytime functioning (fewer daytime impairment symptoms).

Search