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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

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
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
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-HT1A 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-HT1A and 5-HT1D 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.
sexual dysfunction, prevalence, men, placebo-controlled study, 5-ht1a agonist, erectile dysfunction, paroxetine, sildenafil citrate, depressed-patients, efficacy, placebo, double-blind, controlled trial, release, ssri
0269-8811
55-63
Baldwin, David
1beaa192-0ef1-4914-897a-3a49fc2ed15e
Hutchison, John
34d249a1-95cd-4b8c-bb55-592fb53d58b6
Donaldson, Kirsteen
d797c669-c9c1-4c9d-af6b-14b2ab72ccf5
Shaw, Bob
d447cb6e-4c1f-4cff-8c56-db119ee4efae
Smithers, Andrew
7798e039-2efd-4831-9bbe-dd9fe33b37d9
Baldwin, David
1beaa192-0ef1-4914-897a-3a49fc2ed15e
Hutchison, John
34d249a1-95cd-4b8c-bb55-592fb53d58b6
Donaldson, Kirsteen
d797c669-c9c1-4c9d-af6b-14b2ab72ccf5
Shaw, Bob
d447cb6e-4c1f-4cff-8c56-db119ee4efae
Smithers, Andrew
7798e039-2efd-4831-9bbe-dd9fe33b37d9

Baldwin, David, Hutchison, John, Donaldson, Kirsteen, Shaw, Bob and Smithers, Andrew (2008) 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. Journal of Psychopharmacology, 22 (1), 55-63. (doi:10.1177/0269881107078490).

Record type: Article

Abstract

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-HT1A 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-HT1A and 5-HT1D 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.

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More information

Published date: 2008
Keywords: sexual dysfunction, prevalence, men, placebo-controlled study, 5-ht1a agonist, erectile dysfunction, paroxetine, sildenafil citrate, depressed-patients, efficacy, placebo, double-blind, controlled trial, release, ssri

Identifiers

Local EPrints ID: 62245
URI: https://eprints.soton.ac.uk/id/eprint/62245
ISSN: 0269-8811
PURE UUID: 47d81bd4-3543-47f0-bd4c-37e88cb464a0

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Date deposited: 05 Sep 2008
Last modified: 13 Mar 2019 20:27

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