A Double-Blind Comparison of Sexual Functioning, Antidepressant Efficacy, and Tolerability Between Agomelatine and Venlafaxine XR

Abstract

Impaired sexual function is associated with major depressive disorder in the untreated state and is often more prevalent during antidepressant therapy, which frequently results in poor treatment compliance. In this double-blind, multicenter study, the effects of agomelatine (an MT1 and MT2 agonist and 5HT-2C antagonist) and venlafaxine XR on sexual function were compared using the Sex Effects Scale in depressed patients. A total of 276 male and female patients received either agomelatine (50 mg) or venlafaxine XR (titrated to a target dose of 150 mg/d) for 12 weeks. Those who were sexually active at baseline (n = 193) and those who, in addition, achieved remission (n = 111) were defined a priori for analyses of change in sexual function. Treatment-emergent sexual dysfunction was significantly less prevalent among patients who received agomelatine, and venlafaxine XR was associated with significantly greater deterioration on the Sex Effects Scale domains of desire and orgasm. Both treatments resulted in equivalently high rates of remission (agomelatine, 73%; venlafaxine XR, 66.9%), although fewer patients in the agomelatine group discontinued treatment because of adverse events (agomelatine, 2.2%, vs venlafaxine XR, 8.6%). Agomelatine seems to be an efficacious antidepressant with a superior sexual side effect profile compared with venlafaxine XR, although superiority to placebo was not evaluated in this trial.

The impact of severe mental disorders and psychotropic medications on sexual health and its implications for clinical management

“…Some novel antidepressants may have a relatively low propensity for adverse effects on sexual function 73 . Randomized controlled trials with agomelatine suggest it has fewer adverse effects on sexual functioning than some other antidepressants, which is probably due to its antagonist effects at the 5-HT2C receptor, rather than the agonist effects at melatonin receptors [74][75][76][77] , although the absence of effects on nitrergic relaxation of corpus cavernosum smooth muscle may also be relevant 78 .…”

Pooled Analysis of Four Non-Interventional Studies: Effectiveness and Tolerability of the Antidepressant Agomelatine in Daily Practice

“…Additionally it is not a substrate, inducer, or inhibitor of P-glycoprotein (P-gp) [11][12][13]. Antidepressant efficacy and tolerability of agomelatine are confirmed in numerous clinical studies [10,[14][15][16][17][18][19][20][21][22][23][24][25][26][27].…”

Agomelatine: a review for general practitioners

“…18,19 Acute efficacy vs. other antidepressants Agomelatine (25-50 mg) showed non-inferiority compared to the SSRI, sertraline (50-100 mg) with a greater proportion of responders at week 2, as well as to the SNRI, venlafaxine (75-150 mg) in clinical trials of 6-12 weeks' duration. [20][21][22][23] Compared to venlafaxine XR, fewer patients in the agomelatine group discontinued treatment because of adverse events (agomelatine 2.2%, vs. venlafaxine XR 8.6%), although both treatments resulted in equivalently high rates of remission (agomelatine 73%, venlafaxine XR 66.9%). 23 Agomelatine was effective across the range of severities of depression, including in patients with severe depression.…”