OBJECTIVE: The goal of this study was to compare the efficacy and safety of topiramate versus placebo in the treatment of aggression in women who meet the criteria for borderline personality disorder. METHOD: We conducted a double-blind, placebo-controlled study of topiramate in 29 female subjects (response rate 93.5%) meeting SCID (Structured Clinical Interview for DSM-IV) criteria for borderline personality disorder. The subjects were randomly assigned in a 2:1 ratio to topiramate (N = 21, analysis based on N = 19) or placebo (N = 10). Treatment lasted 8 weeks (November 2003-January 2004). Primary outcome measures were self-reported changes on the anger subscales of the State-Trait Anger Expression Inventory (STAXI). RESULTS: Significant improvements on 4 subscales of the STAXI (state-anger, trait-anger, anger-out, anger-control) were observed in the topiramate-treated subjects after 8 weeks, in comparison with the placebo group. The difference in improvement in score between the 2 groups for state-anger, trait-anger, and anger-out ranged from 21% to 24%, and the difference for anger-control was -13%. As an exception, a difference of only 8.5% (p < .2) was found on the anger-in subscale. Significantly greater weight loss was observed in the topiramate-treated group than in those treated with placebo (difference in weight loss between the 2 groups: 2.3 kg [5.1 lb] [3.2%]; 95% CI = 1.3% to 4.4%, p < .01). All patients tolerated topiramate well. CONCLUSIONS:Topiramate appears to be a safe and effective agent in the treatment of anger in women with borderline personality disorder as defined by SCID criteria. Additionally, significant weight loss can be expected.
RCT Entities:
OBJECTIVE: The goal of this study was to compare the efficacy and safety of topiramate versus placebo in the treatment of aggression in women who meet the criteria for borderline personality disorder. METHOD: We conducted a double-blind, placebo-controlled study of topiramate in 29 female subjects (response rate 93.5%) meeting SCID (Structured Clinical Interview for DSM-IV) criteria for borderline personality disorder. The subjects were randomly assigned in a 2:1 ratio to topiramate (N = 21, analysis based on N = 19) or placebo (N = 10). Treatment lasted 8 weeks (November 2003-January 2004). Primary outcome measures were self-reported changes on the anger subscales of the State-Trait Anger Expression Inventory (STAXI). RESULTS: Significant improvements on 4 subscales of the STAXI (state-anger, trait-anger, anger-out, anger-control) were observed in the topiramate-treated subjects after 8 weeks, in comparison with the placebo group. The difference in improvement in score between the 2 groups for state-anger, trait-anger, and anger-out ranged from 21% to 24%, and the difference for anger-control was -13%. As an exception, a difference of only 8.5% (p < .2) was found on the anger-in subscale. Significantly greater weight loss was observed in the topiramate-treated group than in those treated with placebo (difference in weight loss between the 2 groups: 2.3 kg [5.1 lb] [3.2%]; 95% CI = 1.3% to 4.4%, p < .01). All patients tolerated topiramate well. CONCLUSIONS:Topiramate appears to be a safe and effective agent in the treatment of anger in women with borderline personality disorder as defined by SCID criteria. Additionally, significant weight loss can be expected.
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