Better sexual acceptability of agomelatine (25 and 50 mg) compared to escitalopram (20 mg) in healthy volunteers. A 9-week, placebo-controlled study using the PRSexDQ scale.
The present double-blind, placebo-controlled study evaluates the effects of agomelatine and the selective serotonin reuptake inhibitor escitalopram on sexual dysfunction in healthy men and women.


METHODS
A total of 133 healthy volunteers (67 men, 66 women) were randomly assigned to agomelatine (25 or 50 mg) or escitalopram (20 mg) or placebo for nine weeks. Sexual acceptability was evaluated by using the psychotropic-related sexual dysfunction questionnaire 5-items total score and sexual dysfunction relative to each sub-score (in 110 volunteers with sexual activity). Sexual dysfunction was evaluated at baseline and after two, five and eight weeks of treatment and one week after drug discontinuation.


RESULTS
The psychotropic-related sexual dysfunction questionnaire 5-items total score was significantly lower in both agomelatine groups versus escitalopram at all visits (p < 0.01 to p < 0.0001) with no difference between agomelatine and placebo nor between both agomelatine doses. Similar results were observed after drug discontinuation. The total score was significantly higher in the escitalopram group than in the placebo group at each post-baseline visit (p < 0.01 to p < 0.001). Similar results were observed regardless of volunteers' gender. Compared to placebo, only escitalopram significantly impaired dysfunction relative to "delayed orgasm or ejaculation" (p < 0.01) and "absence of orgasm or ejaculation" (p < 0.05 to p < 0.01). The percentage of participants with a sexual dysfunction was higher in the escitalopram group than in agomelatine groups (p < 0.01 to p < 0.05) and placebo (p < 0.01).


CONCLUSIONS
The study confirms the better sexual acceptability profile of agomelatine (25 or 50 mg) in healthy men and women, compared to escitalopram.


BACKGROUND
Evaluation of the effect of agomelatine and escitalopram on emotions and motivation in healthy male and female volunteers.


BACKGROUND
ISRCTN75872983.
Hospital Universitario de Salamanca, Nursing School of Salamanca, IBSAL, Salamanca, Spain amontejo@usal.es.
Angel L
AL
Montejo
Neuroscience and Psychiatry Unit, The University of Manchester, Manchester, UK.
J F W
JF
Deakin
Centre Hospitalier Sainte Anne, Paris, France.
Raphael
R
Gaillard
University Department of Psychiatry, Warneford Hospital, Oxford, UK.
Catherine
C
Harmer
Institut du Cerveau et de la Moelle Epinière, Hôpital de la Pitié-Salpêtrière, Paris, France.
Florent
F
Meyniel
rue Marbeuf, Paris, France.
Artin
A
Jabourian
Institut de Recherches Internationales Servier (IRIS), Suresnes, France.
Cecilia
C
Gabriel
Institut de Recherches Internationales Servier (IRIS), Suresnes, France.
Celine
C
Gruget
University Department of Psychiatry, Warneford Hospital, Oxford, UK.
Corinna
C
Klinge
University Department of Psychiatry, Warneford Hospital, Oxford, UK.
Christine
C
MacFayden
Neuroscience and Psychiatry Unit, The University of Manchester, Manchester, UK.
Holly
H
Milligan
Neuroscience and Psychiatry Unit, The University of Manchester, Manchester, UK.
Emma
E
Mullings
University Department of Psychiatry, Warneford Hospital, Oxford, UK.
Guy
G
Goodwin
D000081:Acetamides / Q000008:administration & dosage*; D000328:Adult; D015283:Citalopram / Q000008:administration & dosage*; D004311:Double-Blind Method; D004644:Emotions / Q000187:drug effects; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage*; D008297:Male; D011569:Psychiatric Status Rating Scales; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage*; D020018:Sexual Dysfunctions, Psychological / Q000188:drug therapy*; D011795:Surveys and Questionnaires; D055815:Young Adult; D009281:Naphthalenes
D000081:Acetamides; D015283:Citalopram; D006993:Hypnotics and Sedatives; D017367:Selective Serotonin Reuptake Inhibitors; C084711:agomelatine; D009281:Naphthalenes
Sexual dysfunction; agomelatine; antidepressant; escitalopram; healthy volunteers; tolerability