Sildenafil in the treatment of antipsychotic-induced erectile dysfunction: a randomized, double-blind, placebo-controlled, flexible-dose, two-way crossover trial.
OBJECTIVE
Antipsychotic-induced erectile dysfunction is a significant clinical problem and is a common reason for poor medication compliance. This report studied the efficacy and tolerability of sildenafil citrate in patients with antipsychotic-induced erectile dysfunction.


METHODS
The study design was a randomized, double-blind, placebo-controlled, flexible-dose, two-way crossover trial carried out at a tertiary referral center. Thirty-two married male outpatients with schizophrenia or delusional disorder and antipsychotic-induced erectile dysfunction were recruited for the trial. Sexual function was assessed from patient logs of sexual activity.


RESULTS
Thirty-two subjects and their spouses, who agreed to take part in the study, were included in the crossover trial. Thirty-one (96.9%) completed the trial. There was no significant period effect or treatment-period interaction. Patients reported significant improvement while taking sildenafil in the number of adequate erections, satisfaction with sexual intercourse, and the duration of erections over 2 weeks. The odds ratios for adequate erections and for satisfactory sexual intercourse with sildenafil were 4.07 and 3.77, respectively. The effect of sildenafil remained significant even after adjustment for period and week effects and treatment-period interaction with Poisson regression analysis. There were no major side effects or adverse drug interactions.


CONCLUSIONS
Sildenafil citrate is safe and effective in the treatment of antipsychotic-induced erectile dysfunction. It is also well tolerated.
Gopalakrishnan
Rajesh
R
Department of Psychiatry, Christian Medical College, Vellore 632002, India. rajeshg28in@yahoo.co.in
Jacob
K S
KS
Kuruvilla
Anju
A
Vasantharaj
B
B
John
Jacob K
JK
D015106:3',5'-Cyclic-GMP Phosphodiesterases / Q000627:therapeutic use*; D000328:Adult; D014150:Antipsychotic Agents / Q000009:adverse effects*; D015897:Comorbidity; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D007172:Erectile Dysfunction / Q000139:chemically induced* / Q000188:drug therapy* / Q000453:epidemiology; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000627:therapeutic use*; D010919:Placebos; D011388:Prolactin / Q000097:blood; D011687:Purines; D012044:Regression Analysis; D012559:Schizophrenia / Q000188:drug therapy / Q000453:epidemiology; D012563:Schizophrenia, Paranoid / Q000188:drug therapy / Q000453:epidemiology / Q000523:psychology; D012725:Sexual Behavior / Q000523:psychology; D000068677:Sildenafil Citrate; D013450:Sulfones; D016896:Treatment Outcome
D014150:Antipsychotic Agents; D010879:Piperazines; D010919:Placebos; D011687:Purines; D013450:Sulfones; D011388:Prolactin; D000068677:Sildenafil Citrate; D015106:3',5'-Cyclic-GMP Phosphodiesterases