Table 15.2 (continued)

Antidepressant

Clinical study

Clinical observations

Pei et al. (2014)

The intra-subject coefficient of variability calculated for

Cmax and AUC 0-T was 78.34% and 43.52%,

respectively, in Chinese healthy subjects

Agomelatine

He et al. (2018)

A single dose of 30 mg/kg celecoxib significantly

increased the area under the concentration-time curve

(AUC) and maximum concentration of agomelatine. In

addition, celecoxib inhibited the metabolism of

agomelatine in the in vitro studies, which was

determined to be by a competitive mechanism on

CYP2C9 isozyme. These results indicated that

celecoxib has an inhibitory effect on the metabolism of

agomelatine both in vivo and in vitro

Freiesleben and

Furczyk (2015)

Agomelatine was found to be associated with higher

rates of liver injury than both placebo and the four

active comparator antidepressants used in the clinical

trials for agomelatine, with rates as high as 4.6% for

agomelatine compared to 2.1% for placebo, 1.4% for

escitalopram, 0.6% for paroxetine, 0.4% for fluoxetine,

and 0% for sertraline. As agomelatine has a potential

risk of liver injury, clinicians must carefully monitor

liver function throughout treatment. However,

agomelatine’s unique mechanism of action and

favorable safety profile render it a valuable treatment

option

Tianeptine

Zheng and Kim

(2014)

The PK parameters were assessed in the 40 subjects

after taking a single dose of 12.5 mg tianeptine sodium.

In the randomized, 2-sequence, 2-treatment crossover

study, tianeptine Cmax for the test formulation was

283.13  57.58 ng/mL (mean  SD), and for the

reference formulation was 272.50  59.00 ng/mL. The

AUC of tianeptine was 803.24  180.94 ng h/mL for

the test formulation and 792.27  180.93 ng h/mL for

the reference formulation. The geometric mean ratio

(%) of the test to reference formulation was 104.04

(90% CI: 99.66–108.61) for Cmax and 101.30 (98.01–

104.71) for AUC. No clinically significant adverse

events were observed during the study

Tianeptine

Saiz-Ruiz et al.

(1998)

In a group of 63 elderly patients (mean age, 68.8 years;

range, 65–80 years) with depressive symptoms (major

depression, 55.6%; dysthymia, 44.4%) were included

in a 3-month open multicenter study with tianeptine

(25 mg/day). Forty-three patients (68.2%) completed

the study. There were no drop-outs due to side effects.

Total Montgomery and Asberg depression rating scale

scores were significantly decreased ( p < 0.01) on day

14, with a response rate of 76.7%. Improvements were

also observed in anxiety and cognitive performance.

Side-effects were seen only in 11.7% of patients, with

no changes in laboratory or ancillary safety parameters.

Tianeptine is thus effective and well tolerated in this

category of patients

258

M. Bhaskar et al.