A Randomized, Double–Blind, Placebo Controlled, Crossover Study Of The Effect Of Agomelatine On Saccadic Eye Movements In Healthy Volunteers Using Electro–oculographic Method

Gaddameedi Arun Jyothi; Gaddameedi Arvind; G Ramakanth; UshaRani P

Volume : VII, Issue : II, February - 2018

A Randomized, Double–Blind, Placebo Controlled, Crossover Study Of The Effect Of Agomelatine On Saccadic Eye Movements In Healthy Volunteers Using Electro–oculographic Method

Gaddameedi Arun Jyothi, Gaddameedi Arvind, G Ramakanth, Usharani P

Abstract :

Background: Saccadic eye movements (SEM) have proved to be a valuable marker of central nervous system (CNS) function. Circadian rhythm progressively influences the saccadic eye movements. Agomelatine, a melatonergic antidepressant improves quality of sleep by resynchronization of the circadian rhythm. Hence, this study was designed to evaluate the effect and safety of single dose of Tab. Agomelatine 25 mg on saccadic eye movements in healthy human volunteers.

Methods: After approval from IEC and after taking writtern informed consent, 12 healthy subjects were randomized to receive either single dose of Tab. Agomelatine 25mg or placebo in a crossover design. Saccadic eye movements were recorded using electro–occulographic (EOG) method at 3 time points – pre–drug (baseline), 90min and 150min post drug at 10⁰ – 60⁰. The primary efficacy parameters were changes in saccade duration, peak saccadic velocity and latency period.

Results: In the agomelatine group, compared to baseline, at 90 and 150min post drug, there was a significant increase in saccade duration (SD) (p<0.05) and significant reduction in peak saccadic velocity (PSV) and latency period (LP) (p<0.05). No significant change was observed in latency period at 90min post drug . There were no significant changes in efficacy parameters with placebo. When agomelatine was compared to placebo at 90 min &150min post drug, SD significantly increased (p<0.05), PSV significantly decreased (p<0.05). At 150min post drug only latency period significantly decreased at 60⁰(p<0.05). Agomelatine was well tolerated.

Conclusion: Saccadic eye movement analysis provides a novel method of assessment of CNS function. The administration of single dose of Agomelatine 25mg significantly altered saccadic eye movements in healthy volunteers as determined by the electro–oculographic recording. However, further studies in larger number of subjects are required to confirm this effect.