title: Open-label sildenafil treatment of partial and non-responders to double-blind treatment in men with antidepressant-associated sexual dysfunction.
abstract: Fifty partial and non-responders (Clinical Global Impression-Sexual Function (CGI-SF) score>2), out of 76 men who completed a 6-week, double-blind, placebo-controlled trial of sildenafil treatment for serotonergic antidepressant-associated sexual dysfunction, were eligible for an additional 6-week trial of open-label sildenafil (50 mg adjustable to 100 mg) under the same protocol, with blind maintained to initial assignment. Participation (double-blind and open-label) required major depressive disorder in remission (MDD-R) and continuing antidepressant medication. Forty-three entered open-label study: 16/17 initially randomized to sildenafil (sildenafil/sildenafil) and 27/33 initially randomized to placebo (placebo/sildenafil). Thirty-five of 43 (81%) achieved full response (CGI-SF<or=2): placebo/sildenafil 23/27 (85%); sildenafil/sildenafil 12/16 (75%); P<0.0001 for changes and P=0.4 between groups. Secondary measures of erectile function and overall satisfaction improved in both groups (P<0.03). Hamilton Depression Rating Scale scores improved (placebo/sildenafil; P<or=0.05) or remained stable (sildenafil/sildenafil). In men with MDD-R who maintained antidepressant adherence, 81% of double-blind partial and non-responders treated with open-label sildenafil responded fully.
authors.affiliation: 1Department of Psychiatry, University of New Mexico School of Medicine, Albuquerque, NM 87131-52886, USA. geon@unm.edu
authors.forename: H G
authors.initials: HG
authors.lastname: Nurnberg
authors.forename: M
authors.initials: M
authors.lastname: Fava
authors.forename: A J
authors.initials: AJ
authors.lastname: Gelenberg
authors.forename: P L
authors.initials: PL
authors.lastname: Hensley
authors.forename: S
authors.initials: S
authors.lastname: Paine
mesh_terms: D000928:Antidepressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000139:chemically induced / Q000188:drug therapy* / Q000523:psychology; D006801:Humans; D008297:Male; D010726:Phosphodiesterase Inhibitors / Q000627:therapeutic use*; D010879:Piperazines / Q000627:therapeutic use*; D011687:Purines / Q000627:therapeutic use; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D020018:Sexual Dysfunctions, Psychological / Q000139:chemically induced / Q000188:drug therapy*; D000068677:Sildenafil Citrate; D013450:Sulfones / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000928:Antidepressive Agents; D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D011687:Purines; D017367:Selective Serotonin Reuptake Inhibitors; D000068677:Sildenafil Citrate; D013450:Sulfones