BACKGROUND: Isolated reports suggest that escitalopram may be effective for impulsive-compulsive Internet usage disorder (IC-IUD), an impulse-control disorder characterized by excessive time spent on the Internet at the expense of occupational, relationship, and social activities. To assess the safety and efficacy of escitalopram in IC-IUD, we conducted a 10-week, open-label trial followed by a 9-week, double-blind, placebo-controlled discontinuation phase. METHOD:From December 2002 to October 2004, 19 adult subjects with IC-IUD (defined as time consuming, uncontrollable, distressing, and resulting in social, occupational, or financial difficulties) were enrolled. Escitalopram was started at 10 mg/day, then increased and maintained at 20 mg/day for 10 weeks at the end of which completers were randomly assigned to placebo or escitalopram for 9 additional weeks. Two key outcome measures were used: hours spent weekly in nonessential Internet use and overall clinical response (subjects rated "much improved" or "very much improved" on the Clinical Global Impressions-Improvement scale [CGI-I]). RESULTS:Fourteen subjects completed the entire study. At the end of the 10th week of open-label esci-talopram, Internet usage decreased significantly from a mean of 36.8 hours/week at baseline to 16.5 hours/week (paired t test: t = 3.58; p = .002). In addition, 64.7% of the sample (N = 11) were considered CGI-I responders. At the end of the double-blind phase, there were no significant differences in outcome measures between patients taking placebo compared to escitalopram (analysis of variance with repeated measures, p > .05). CONCLUSION: Patients showed a significant improvement of IC-IUD symptoms during the open-label escitalopram phase. There was no significant difference between the escitalopram and placebo groups at the end of the subsequent double-blind phase; both groups maintained the gains made in the initial open-label treatment. Larger controlled trials are needed to investigate the efficacy of this and other pharmacologic agents in the treatment of IC-IUD. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00565422.
RCT Entities:
BACKGROUND: Isolated reports suggest that escitalopram may be effective for impulsive-compulsive Internet usage disorder (IC-IUD), an impulse-control disorder characterized by excessive time spent on the Internet at the expense of occupational, relationship, and social activities. To assess the safety and efficacy of escitalopram in IC-IUD, we conducted a 10-week, open-label trial followed by a 9-week, double-blind, placebo-controlled discontinuation phase. METHOD: From December 2002 to October 2004, 19 adult subjects with IC-IUD (defined as time consuming, uncontrollable, distressing, and resulting in social, occupational, or financial difficulties) were enrolled. Escitalopram was started at 10 mg/day, then increased and maintained at 20 mg/day for 10 weeks at the end of which completers were randomly assigned to placebo or escitalopram for 9 additional weeks. Two key outcome measures were used: hours spent weekly in nonessential Internet use and overall clinical response (subjects rated "much improved" or "very much improved" on the Clinical Global Impressions-Improvement scale [CGI-I]). RESULTS: Fourteen subjects completed the entire study. At the end of the 10th week of open-label esci-talopram, Internet usage decreased significantly from a mean of 36.8 hours/week at baseline to 16.5 hours/week (paired t test: t = 3.58; p = .002). In addition, 64.7% of the sample (N = 11) were considered CGI-I responders. At the end of the double-blind phase, there were no significant differences in outcome measures between patients taking placebo compared to escitalopram (analysis of variance with repeated measures, p > .05). CONCLUSION:Patients showed a significant improvement of IC-IUD symptoms during the open-label escitalopram phase. There was no significant difference between the escitalopram and placebo groups at the end of the subsequent double-blind phase; both groups maintained the gains made in the initial open-label treatment. Larger controlled trials are needed to investigate the efficacy of this and other pharmacologic agents in the treatment of IC-IUD. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00565422.