Comparison of paroxetine and agomelatine in depressed type 2 diabetes mellitus patients: a double-blind, randomized, clinical trial

Figures & data

Table 1 Demographic of included patients

	Number	Sex (F/M)	Age, years (mean/SD)	Education, years (mean/SD)	Smoke (n)	Alcohol (n)
Paroxetine	56	25/31	52.50± 10.27	9.67±5.33	11	8
Agomelatine	60	28/32	50.82±11.36	9.53±4.79	15	7
t/χ^2	NA	0.048	−0.67	0.83	0.48	0.18
P-value	NA	0.83	0.50	0.84	0.49	0.67

Abbreviations: F, female; M, male; NA, not applicable; SD, standard deviation.

Table 2 Mean scores ± SD of outcomes in paroxetine and agomelatine groups

Outcomes	Group	Initial assessment	Six weeks	Final assessment	t	P-valuea
HDRS	Paroxetine	23.94±3.07	16.00±6.77	10.50±4.33	15.16	<0.0001
	Agomelatine	24.20±3.38	14.80±6.41	9.35±3.79	18.45	<0.0001
HARS	Paroxetine	16.78±3.35	13.81 ±3.69	8.56±2.62	11.56	<0.0001
	Agomelatine	16.38±4.19	12.48±3.19	6.93±2.15	12.68	<0.0001
HbA1c (%)	Paroxetine	7.71 ±0.46	NA	7.61 ±0.40	0.92	0.376
	Agomelatine	7.84±0.45	NA	7.26±0.46	5.56	<0.0001
FPG (mmol/L)	Paroxetine	8.07±0.79	NA	7.89±0.78	0.97	0.209
	Agomelatine	8.18±0.85	NA	8.03±0.77	0.85	0.333
BMI (kg/m^2)	Paroxetine	25.91±3.31	NA	27.19±3.45	−1.61	0.111
	Agomelatine	25.63±4.18	NA	24.74±3.46	1.03	0.306

Note:

a P-value was obtained by comparing the final assessment to the initial assessment.

Abbreviations: SD, standard deviation; HDRS, Hamilton Depression Rating Scale; HARS, Hamilton Anxiety Rating Scale; HbA_1c, hemoglobin A_1c; FPG, fasting plasma glucose; BMI, body mass index; NA, not available.

Table 3 Treatment-related adverse events in paroxetine and agomelatine groups

	Nausea	Headache	Dry mouth	Diarrhea	Anxiety	Dizziness	Insomnia
Paroxetine, n (%)	3 (5.6%)	2 (3.6%)	3 (5.6%)	2 (3.6%)	4 (7.1%)	2 (3.6%)	6 (10.7%)
Agomelatine, n (%)	1 (1.7%)	2 (3.3%)	2 (3.3%)	1 (1.7%)	4 (6.7%)	3 (5.0%)	2 (3.3%)
χ^2	1.19	0.005	0.29	0.42	0.01	0.17	2.46
P-value	0.28	0.94	0.67	0.61	0.92	0.71	0.12