BACKGROUND: Depression is associated with increased aggression and diminished ability and quality of life. The goal of this study was to compare the efficacy of topiramate in influencing depressive symptoms, aggression, ability, and health related quality of life in depressive women. METHODS: We conducted a randomized, double-blind, placebo-controlled 10-week study of topiramate in 64 female subjects from the general population who met criteria for recurrent major depressive disorder. Primary outcome measures were changes on the Hamilton Depression Rating Scale (HDRS), the State-Trait Anger Expression Inventory (STAXI), the Test of Attention (d2), and the SF-36 Health Survey (SF-36). RESULTS: According to the intent-to-treat principle, a significant difference on the HDRS (P=0.02), all scales of STAXI (all P<0.001), Total efficiency of d2 (P<0.001), and on most scales of SF-36 (P between 0.15 and <0.001) were observed in the topiramate-treated subjects comprised the placebo group. The reduction in expression of anger correlated significantly with changes on the HDRS, and several scales of d2 and SF-36. Additional weight loss, which was significantly more pronounced in the topiramate group than in those treated with a placebo, was ascertained (difference in weight loss between the two groups: 4.2 kg, P<0.001). All the patients tolerated topiramate relatively well. LIMITATIONS: Only moderately ill women were included. CONCLUSIONS:Topiramate appears to be an effective agent in the reduction of depressive symptoms and anger and in the improvement of ability and health-related quality of life in depressive women. Additional weight loss can be expected.
RCT Entities:
BACKGROUND:Depression is associated with increased aggression and diminished ability and quality of life. The goal of this study was to compare the efficacy of topiramate in influencing depressive symptoms, aggression, ability, and health related quality of life in depressivewomen. METHODS: We conducted a randomized, double-blind, placebo-controlled 10-week study of topiramate in 64 female subjects from the general population who met criteria for recurrent major depressive disorder. Primary outcome measures were changes on the Hamilton Depression Rating Scale (HDRS), the State-Trait Anger Expression Inventory (STAXI), the Test of Attention (d2), and the SF-36 Health Survey (SF-36). RESULTS: According to the intent-to-treat principle, a significant difference on the HDRS (P=0.02), all scales of STAXI (all P<0.001), Total efficiency of d2 (P<0.001), and on most scales of SF-36 (P between 0.15 and <0.001) were observed in the topiramate-treated subjects comprised the placebo group. The reduction in expression of anger correlated significantly with changes on the HDRS, and several scales of d2 and SF-36. Additional weight loss, which was significantly more pronounced in the topiramate group than in those treated with a placebo, was ascertained (difference in weight loss between the two groups: 4.2 kg, P<0.001). All the patients tolerated topiramate relatively well. LIMITATIONS: Only moderately ill women were included. CONCLUSIONS:Topiramate appears to be an effective agent in the reduction of depressive symptoms and anger and in the improvement of ability and health-related quality of life in depressivewomen. Additional weight loss can be expected.
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