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P.2.112 Combination of topiramate in acute mania
P2 Affective disorders and antidepressants
$440
C o n c l u s i o n s : The major finding of this study is that the concentration of ANP and BNP during rest and exercise is lower in patients with major depressive disorder than in healthy controls. This might be caused by a lower physical capacity in the depressive group. Hypothetically the lower levels o f ANP and BNP might result in a diminished ANP-, BNP-negative feedback mechanism on the HPA system in depressive disorders.
References [1] Barletta G, Stefani L, Del Bene R, et al. (1998) Effects of exercise on natfiuretic peptides and cardiac function in man. Int J Cardiol 65: 217 25. [2] Levin ER, Gardner DG, Samson WK. (1998) Natriuretic peptides. N Engl J Med 339:321 8. [3] Strohle A, Holsboer E (2003) Stress responsive neurohormones in depression and anxiety. Pharmacopsychiatry 36; Suppl 3:$207 14.
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C o n c l u s i o n : Both groups showed comparable antidepressant efficacy, whereas agomelatine offered a better profile of sexual function.
References [1] MontgomeL%S.A., Baldwin, D.S., Riley, A. 2002. Antidepressant medications: a review of the evidence for drug-induced sexual dysfunction. Journal of Affective Disorders 69:11%140. [2] Clayton, A.H., Zajecka, J., Ferguson, J.M., Filipiak-Reisner, J.K., Brown, M.T., Schwartz, G.E. 2003. Lack of sexual dysfunction with the selective noradrenaline reuptake inhibitor reboxetine during U'eatment for major depressive disorder. International Clinical Psychopharmacology 18:151 156. [3] Loo, H., Hale, A., Dhaenen, H. 2002. Determination of the dose of agomelatine, a melatoninergic agonist and selective 5-HT(2C) antagonist, in the treatment of major depressive disorder: a placebo-controlled dose range study. International Clinical Psychopharmacology 17: 23% 247.
Sexual function in remitted depressed patients following agomelatine and venlafaxine XR treatment
S.H. Kennedy*. University Health Network, Department of Psychiatty, Toronto, Canada Background and objectives: Current antidepressant medications have comparable effectiveness, the most recent ones offering better safety profile. However sexual dysfunction is recognised as a potential side-effect across all classes of antidepressants (MAOIs, TCAs, SSRIs, SNRIs and newer antidepressants [1,2]). Agomelatine (Valdoxan) is the first melatonergic antidepressant. Its innovative pharmacological profile combines melatonin receptor agonist and 5-HT2C antagonist properties. Agomelatine 25 mg/day3 has been shown to be effective in MDD with a good safety and tolerability profile. In the course of development, agomelatine did not appear to be associated with sexual dysfunction. The purpose of this study was to assess the sexual acceptability of agomelatine 50mg in comparison with venlafaxine 150mg, in remitted depressed patients. M e t h o d s : This double-blind randomised multicentre trial involved out-patients aged between 18 and 60 (inclusive) who met the criteria for MDD (DSM-IV-TR), single or recurrent episode, and had a baseline MADRS score > 20. At entry into the study, patients were randomised either to agomelatine 50 mg/day or venlafaxine 75 mg/day from W0 to W2, then venlafaxine 150mg/day from W2 to W12. They were assessed with MADRS at W0, W2, W6, W10 and W12. Stable remitted patients were defined as being responders (having a 50% reduction from baseline MADRS score) at W12 and having a MADRS score < 12 at W12. Sexual function was evaluated using the Sex Effects (SEX-FX) scale and was assessed at W0, W2, W6, W10 and W12. Results: 277 patients were included in the study. 78 o f 137 (57%) agomelatine and 83 of 140 (59%) venlafaxine treated patients achieved remission. In the Full Analysis Set the rate of responders was 82.5% in the agomelatine group and 79.9% in the venlafaxine group. Last MADRS scores were respectively 10.1±7.8 and 9.8±7.9 in the agomelatine and venlafaxine groups (95% CI [-2.16;1.55]). Among sexually active patients (n 111) at the end of the trial, 41.2% of venlafaxine-treated patients experienced sexual dysfunction on desire-arousal factor in comparison with 20% in agomelatine group only (p 0.015, Chi-squared test). On the orgasm factor 47.0% of venlafaxine-treated patients experienced sexual dysfunction versus 20% in agomelatine group (p < 0.002, Chi-squared test).
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Combination of topiramate in acute mania
B.H. Yoon*, A. Bae, Y.H. Sea, J.H. Kim, M.K. Kim. Naju National Hospital, Department of Psychiatty, Naju, Republic of Korea Objectives: Although recent reports on the efficacy of topiramate for bipolar disorder were discouraged, it may be useful for comorbid conditions such as eating disorder, obesity and alcohol dependence. The aim of this study was to reevaluate the efficacy and safety of topiramate as the combination regimen in the treatment of acute mania. M e t h o d s : Twenty-six manic patients were selected through various screening tests. They were randomly assigned to valproate alone or the combination of topiramate and valproate. The study was maintained with double-blind design. Antipsychotics were not allowed and lorazepam was only available as needed. Young Mania Rating Scale (YMRS) was used to evaluate the improvement of manic symptoms at pre-drug baseline and at 1st, 2nd, 4th and 8th week of post-drug. UKU side effect rating scales were done for assessment o f drug-induced side effects. Additionally, body weights were checked at weekly basis to monitor the weight change. Repeated measures of ANOVA was done to compare the effects between two groups. Results: Three patients o f valproate alone and 4 patients of topiramate combination were dropped out. Although it was not significant, more lorazepams were used in topiramate combination group. YMRS of topiramate combination group were significantly decreased than those o f valproate alone even after the use of lorazepam treated as covariates. These effects were especially significant at 1st, 2nd week after treatment in post hoc analysis. There were no differences in side effects between two groups. There were significant decreases of weight in topiramate combination group whereas the increases of weight were found in valproate alone group. C o n c l u s i o n : Although the results showed significant improvement o f manic symptoms in topiramate combination group, it seemed that combination of topiramate was not impressively changed symptoms in terms of clinical sense. But the use of topiramte may be the effective and safe treatment in manic patients with weight problem.
$440
C o n c l u s i o n s : The major finding of this study is that the concentration of ANP and BNP during rest and exercise is lower in patients with major depressive disorder than in healthy controls. This might be caused by a lower physical capacity in the depressive group. Hypothetically the lower levels o f ANP and BNP might result in a diminished ANP-, BNP-negative feedback mechanism on the HPA system in depressive disorders.
References [1] Barletta G, Stefani L, Del Bene R, et al. (1998) Effects of exercise on natfiuretic peptides and cardiac function in man. Int J Cardiol 65: 217 25. [2] Levin ER, Gardner DG, Samson WK. (1998) Natriuretic peptides. N Engl J Med 339:321 8. [3] Strohle A, Holsboer E (2003) Stress responsive neurohormones in depression and anxiety. Pharmacopsychiatry 36; Suppl 3:$207 14.
•
C o n c l u s i o n : Both groups showed comparable antidepressant efficacy, whereas agomelatine offered a better profile of sexual function.
References [1] MontgomeL%S.A., Baldwin, D.S., Riley, A. 2002. Antidepressant medications: a review of the evidence for drug-induced sexual dysfunction. Journal of Affective Disorders 69:11%140. [2] Clayton, A.H., Zajecka, J., Ferguson, J.M., Filipiak-Reisner, J.K., Brown, M.T., Schwartz, G.E. 2003. Lack of sexual dysfunction with the selective noradrenaline reuptake inhibitor reboxetine during U'eatment for major depressive disorder. International Clinical Psychopharmacology 18:151 156. [3] Loo, H., Hale, A., Dhaenen, H. 2002. Determination of the dose of agomelatine, a melatoninergic agonist and selective 5-HT(2C) antagonist, in the treatment of major depressive disorder: a placebo-controlled dose range study. International Clinical Psychopharmacology 17: 23% 247.
Sexual function in remitted depressed patients following agomelatine and venlafaxine XR treatment
S.H. Kennedy*. University Health Network, Department of Psychiatty, Toronto, Canada Background and objectives: Current antidepressant medications have comparable effectiveness, the most recent ones offering better safety profile. However sexual dysfunction is recognised as a potential side-effect across all classes of antidepressants (MAOIs, TCAs, SSRIs, SNRIs and newer antidepressants [1,2]). Agomelatine (Valdoxan) is the first melatonergic antidepressant. Its innovative pharmacological profile combines melatonin receptor agonist and 5-HT2C antagonist properties. Agomelatine 25 mg/day3 has been shown to be effective in MDD with a good safety and tolerability profile. In the course of development, agomelatine did not appear to be associated with sexual dysfunction. The purpose of this study was to assess the sexual acceptability of agomelatine 50mg in comparison with venlafaxine 150mg, in remitted depressed patients. M e t h o d s : This double-blind randomised multicentre trial involved out-patients aged between 18 and 60 (inclusive) who met the criteria for MDD (DSM-IV-TR), single or recurrent episode, and had a baseline MADRS score > 20. At entry into the study, patients were randomised either to agomelatine 50 mg/day or venlafaxine 75 mg/day from W0 to W2, then venlafaxine 150mg/day from W2 to W12. They were assessed with MADRS at W0, W2, W6, W10 and W12. Stable remitted patients were defined as being responders (having a 50% reduction from baseline MADRS score) at W12 and having a MADRS score < 12 at W12. Sexual function was evaluated using the Sex Effects (SEX-FX) scale and was assessed at W0, W2, W6, W10 and W12. Results: 277 patients were included in the study. 78 o f 137 (57%) agomelatine and 83 of 140 (59%) venlafaxine treated patients achieved remission. In the Full Analysis Set the rate of responders was 82.5% in the agomelatine group and 79.9% in the venlafaxine group. Last MADRS scores were respectively 10.1±7.8 and 9.8±7.9 in the agomelatine and venlafaxine groups (95% CI [-2.16;1.55]). Among sexually active patients (n 111) at the end of the trial, 41.2% of venlafaxine-treated patients experienced sexual dysfunction on desire-arousal factor in comparison with 20% in agomelatine group only (p 0.015, Chi-squared test). On the orgasm factor 47.0% of venlafaxine-treated patients experienced sexual dysfunction versus 20% in agomelatine group (p < 0.002, Chi-squared test).
~
Combination of topiramate in acute mania
B.H. Yoon*, A. Bae, Y.H. Sea, J.H. Kim, M.K. Kim. Naju National Hospital, Department of Psychiatty, Naju, Republic of Korea Objectives: Although recent reports on the efficacy of topiramate for bipolar disorder were discouraged, it may be useful for comorbid conditions such as eating disorder, obesity and alcohol dependence. The aim of this study was to reevaluate the efficacy and safety of topiramate as the combination regimen in the treatment of acute mania. M e t h o d s : Twenty-six manic patients were selected through various screening tests. They were randomly assigned to valproate alone or the combination of topiramate and valproate. The study was maintained with double-blind design. Antipsychotics were not allowed and lorazepam was only available as needed. Young Mania Rating Scale (YMRS) was used to evaluate the improvement of manic symptoms at pre-drug baseline and at 1st, 2nd, 4th and 8th week of post-drug. UKU side effect rating scales were done for assessment o f drug-induced side effects. Additionally, body weights were checked at weekly basis to monitor the weight change. Repeated measures of ANOVA was done to compare the effects between two groups. Results: Three patients o f valproate alone and 4 patients of topiramate combination were dropped out. Although it was not significant, more lorazepams were used in topiramate combination group. YMRS of topiramate combination group were significantly decreased than those o f valproate alone even after the use of lorazepam treated as covariates. These effects were especially significant at 1st, 2nd week after treatment in post hoc analysis. There were no differences in side effects between two groups. There were significant decreases of weight in topiramate combination group whereas the increases of weight were found in valproate alone group. C o n c l u s i o n : Although the results showed significant improvement o f manic symptoms in topiramate combination group, it seemed that combination of topiramate was not impressively changed symptoms in terms of clinical sense. But the use of topiramte may be the effective and safe treatment in manic patients with weight problem.