BACKGROUND: Kleptomania has no definitive treatment. Mixed reports of benefit from openly prescribed selective serotonin reuptake inhibitors led us to design a double-blind, placebo-controlled discontinuation trial of escitalopram. METHOD:Between December 2002 and March 2005, we recruited 24 subjects aged >or=20 years with DSM-IV kleptomania of >or=1 year's duration. We excluded subjects with organic mental disorders, psychoses, substance or alcohol abuse, suicidal risk, bipolarI or II disorder, anorexia nervosa, or antisocial personality disorder and subjects requiring other psychotropic medications. Our primary outcome measure was theft episodes per week. A responder was defined as a subject having a > 50% decrease in theft episodes per week and a Clinical Global Impressions-Improvement scale score of "much improved" or "very much improved." Escitalopram was started at 10 mg/day and increased as necessary and tolerated after week 4 to 20 mg/day. At the end of week 7, responders were randomly assigned to a 1-week taper followed by 16 weeks of placebo or to continuation of treatment for 17 weeks at their week 7 escitalopram dose. RESULTS:Nineteen subjects (79%) were week 7 responders and 15 were randomly assigned. Five subjects (4 responders) withdrew early: 1 for unrelated illness, 1 for protocol deviation, 2 for side effects, and 1 for withdrawn consent. Three (43%) of 7 escitalopram subjects relapsed compared with 4 (50%) of 8 placebosubjects (Fisher exact test p = .38). CONCLUSION: The high response rate during open-label escitalopram treatment was not better maintained by double-blind escitalopram than by placebo. Kleptomania may be a heterogeneous pathological behavior better treated with pharma-cotherapy in some cases and psychologically or with combined treatment in others.
RCT Entities:
BACKGROUND:Kleptomania has no definitive treatment. Mixed reports of benefit from openly prescribed selective serotonin reuptake inhibitors led us to design a double-blind, placebo-controlled discontinuation trial of escitalopram. METHOD: Between December 2002 and March 2005, we recruited 24 subjects aged >or=20 years with DSM-IV kleptomania of >or=1 year's duration. We excluded subjects with organic mental disorders, psychoses, substance or alcohol abuse, suicidal risk, bipolar I or II disorder, anorexia nervosa, or antisocial personality disorder and subjects requiring other psychotropic medications. Our primary outcome measure was theft episodes per week. A responder was defined as a subject having a > 50% decrease in theft episodes per week and a Clinical Global Impressions-Improvement scale score of "much improved" or "very much improved." Escitalopram was started at 10 mg/day and increased as necessary and tolerated after week 4 to 20 mg/day. At the end of week 7, responders were randomly assigned to a 1-week taper followed by 16 weeks of placebo or to continuation of treatment for 17 weeks at their week 7 escitalopram dose. RESULTS: Nineteen subjects (79%) were week 7 responders and 15 were randomly assigned. Five subjects (4 responders) withdrew early: 1 for unrelated illness, 1 for protocol deviation, 2 for side effects, and 1 for withdrawn consent. Three (43%) of 7 escitalopram subjects relapsed compared with 4 (50%) of 8 placebo subjects (Fisher exact test p = .38). CONCLUSION: The high response rate during open-label escitalopram treatment was not better maintained by double-blind escitalopram than by placebo. Kleptomania may be a heterogeneous pathological behavior better treated with pharma-cotherapy in some cases and psychologically or with combined treatment in others.