This Article Full Text (PDF) All Versions of this Article: 0269881107078490v1 22/1/55    most recent References Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in Web of Science Similar articles in PubMed Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via Web of Science (3) Citing Articles via Google Scholar Citing Articles via Scopus Google Scholar Articles by Baldwin, D. Articles by Smithers, A. Search for Related Content PubMed PubMed Citation Articles by Baldwin, D. Articles by Smithers, A. Social Bookmarking                         What's this?

Selective serotonin re-uptake inhibitor treatment-emergent sexual dysfunction: randomized double-blind placebo-controlled parallel-group fixed-dose study of a potential adjuvant compound, VML-670

Clinical Neuroscience Division, University of Southampton, Southampton, UK, dsb1{at}soton.ac.uk

John Hutchison

Vernalis Ltd, Oakdene Court, Winnersh, Reading, UK

Kirsteen Donaldson

Vernalis Ltd, Oakdene Court, Winnersh, Reading, UK

Bob Shaw

Vernalis Ltd, Oakdene Court, Winnersh, Reading, UK

Andrew Smithers

Profiad Ltd, Reading, UK

Sexual dysfunction is common during acute and continuation treatment of depressed patients with selective serotonin (5-hydroxytryptamine, 5-HT) re-uptake inhibitors (ssRIs), but there is no consensus on clinical management. Compounds with 5-HT_1A agonist properties have been proposed as adjuvant agents in patients continuing with ssRIs. Randomized double-blind placebo-controlled parallel-group fixed-dose 4-week treatment study. Previously depressed male or female patients in symptomatic remission receiving stable doses of fluoxetine or paroxetine but experiencing treatment-emergent sexual dysfunction were randomised to double-blind treatment with placebo or VML-670 (a 5-HT_1A and 5-HT_1D agonist). sexual dysfunction was assessed by the Arizona sexual Experiences scale (ASEX). Two-hundred and eighty-eight patients (204 women, 84 men; mean age 44.2 years) received VML-670 (n = 149; 107 women, 42 men) or placebo (n = 139; 97 women, 42 men). In the intention-to-treat, last-observation carried forward analysis (n = 282), proportionately more patients became free of sexual dysfunction with VML-670 (34.3% versus 27.9% with placebo) but this difference was not statistically significant. Male patients treated with VML-670 showed a significantly greater (p =0.01) improvement in ability to achieve and maintain penile erection (a secondary outcome measure). A similar proportion of patients reported on-treatment, treatment-emergent adverse events with VML-670 (71.1%) and placebo (68.3%), and a similar proportion experienced at least one treatment-related adverse event (36.9% versus 35.3%). Double-blind treatment with VML-670 offered no significant advantage over placebo on the primary outcome measure in the overall sample. Further studies may be warranted in larger groups of male patients with sexual dysfunction.

Key Words: SSRI • sexual dysfunction • placebo-controlled study • 5-HT1A agonist

This version was published on January 1, 2008

Journal of Psychopharmacology, Vol. 22, No. 1, 55-63 (2008)
DOI: 10.1177/0269881107078490


CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter    What's this?