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P.2.113 Ziprasidone efficacy and safety in acute bipolar mania: 12-week study
P2 Affective disorders and antidepressants
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Ziprasidone efficacy and safety in acute bipolar mania: 12-week study
T.S. Ramey 1 *, S. Murray 2, E. Giller 1 , P. English 1 , R. Riesenberg 3, J. Trivedi 4, V.A. Tochilov 5. ]Pfizer Global
Research and Development, Department of Neuroscience, Groton, CT, USA," ePfizer Inc., Medical, USA," 3Atlanta Center for Medical Research, Bipolar Disorders, USA," 4King George "s Medical College, Department of Psychiatty, India; 5St. Petersburg State Medical Academy, Department of Psychiatty, Russian Federation Purpose: To establish the superior efficacy and tolerability o f ziprasidone versus placebo in the initial treatment o f acute bipolar mania, as well as its long-term maintenance o f effect and tolerability. Methods: 438 bipolar subjects, current episode manic or mixed, were randomized to 3 weeks' flexibly-dosed ziprasidone (40 8 0 m g BID), haloperidol (4 15 m g BID), or placebo. Placebo subjects were reassigned to ziprasidone after Week 3, and were evaluated for safety only. Subjects randomized to ziprasidone or haloperidol received treatment for less than equal to 12 weeks. The primary efficacy measure was MRS mean change from baseline to Week 3. Maintenance o f effect was the percent o f Week 3 responders who were Week 12 responders. Results: Ziprasidone was superior to placebo at Week 3 in both LOCF (P <0.01) and OC (P <0.05) analyses o f mean MRS change. Ziprasidone's effect was significant as early as Day 2, and was maintained to endpoint. 92.5% o f Week 3 ziprasidone responders were still responders at Week 12 (equivalent to haloperidol). The ziprasidone group had lower rates o f EPS at Week 12 and overall lower rates o f adverse events versus haloperidol. Conclusion: Ziprasidone effectively treated subjects with bipolar mania and maintained efficacy throughout the 12-week study. Ziprasidone was safe and well tolerated, with lower rates o f adverse events and EPS than seen with haloperidol.
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Admissions during the climacteric period in bipolar female patients
J. Rodriguez Revuelta 1 *, G.A.V. Garcla Arroyo 2, C.G.J. Caballer Garcla 3. ]Hospital Valle del Nal6n, Asturias, Psychiatty, Gij6n,
Spain; 2Hospital fllvarez Buylla, Asturias, Spain, Psychiatty, Spain; 3Mental Health Center of Gij6n, Asturias, Spain, Psychiatty, Spain 1. S t a t e m e n t on the purpose of the study: Unlikely other affective disorders, the bipolar disorder is a pathology that appears with similar incidence in both sexes. Nevertheless, w o m e n develop more frequently bipolar disorder type II, rapid cycling, mixed episodes and switch to mania as a secondary effect o f antidepressant treatment. Based on these data, it comes up the possibility o f existing differences in the course o f bipolar disorder in w o m e n under the influence o f female sexual hormones and their variations during the reproductive cycle. The proposal is to study the possible influence o f climacteric on women, in relation to the evolution o f bipolar disorder, observing mainly the presence or absence o f severe relapse, reflected on the need o f admission in a psychiatric hospital. Admissions during the climacteric will be compared with the number o f admissions among other age groups. As a control reference is used a group o f patients not affected for climacteric, as male are.
$441
2. Methods used: It is studied a randomized sample o f 75 patients o f both sexes with bipolar disorder, inmates in the Psychiatry Unit o f Hospital Central de Asturias, Spain, from January 1984 to September 2004. It is applied the spss 11.0 statistical program. The variables studied are: Total admissions during the period studied, for both sexes. Admissions during the lapse from 45 to 55 years, theoretic period for the climacteric on women. It is also observed in males for future comparisons. Admissions o f other age groups, for both sexes. Results: Statistical differences are searched, relating the variables in twos: Total admissions confronted to admissions during the period between 45 and 55 years (climacteric o f woman) both for m e n and women. Admissions for 45 to 55 years confronted to admissions for other age groups, both for men and women. Differences among total admissions, admissions during the climacteric period and out o f that period, for both sexes. There are no statistical significant diferences among the various variables studied; all o f them showing p > 0.05.4. Conclusion: In this study it has been observed that the gender does not make specific differences on the need o f admission in a psychiatry unit for bipolar disorder. There are no statistical significant differences between men and w o m e n during the climacteric period, neither in number nor in presence or absence o f admission. Climacteric is not a risk factor for the increase o f hospital admissions.
References [1] Butt VK, Rasgon N. Special considerations in treating bipolar disorder in women. Bipolar Disord. 2004 Feb;6(1):2 13. Leibenlufi E. Women with bipolar illness: clinical and research issues. Am J Psychiatry. 1996 Feb; 153(2): 163 73.
~Mood
disorders in long-term care residential facilities
A. Placentino 1 *, E. Papa 1, S. Barreca 1 , S. Milana 1 , L. Milini 1 , C. Giovannini 1, G.B. Tura 1 , F. Madeddu 2, J. Perez 1 . ]IRCCS
Centro S.Giovanni di Dio, Biological Psychiatry Unit, Brescia, Italy; 2University of Milan-Bicocca, Psychology, Italy Purpose: M o o d disorders are leading causes o f disability and their outcomes often are worse than previously thought. Thus, we investigated the features o f affective patients needing residential care (RFs). Method: The sample consisted o f 426 patients admitted to RFs. It was assessed with the Structured Clinical Interview for D S M - I V (SCID-I and II). The severity o f symptoms was assessed by the BPRS, while the overall assessment o f functioning was obtained from the Global Assessment o f Functioning Scale (GAF, DSM-IV's axis V). The severity o f delusional features was evaluated using the Delusional Experience Rating Scale. Descriptive methods were used to examine background characteristics o f all patients. Whether the measurement o f variables was categorical or scaled, group differences were tested using chi-square or t-test. All analyses were performed using SPSS software (SPSS 11.0 for Windows). Statistical significance was determinated using 0.05 level. Results: O f the 426 subjects, 162 (38%), had a principal diagnosis o f M o o d Disorder: 82 (50%) had M D D with (N 23; 28%) or without (N 59; 72%) psychotic features; 58 (36%) had a BD-I with (N 8; 14%) or without (N 50; 86%) psychotic features and 22 (14%) had a Dysthymia. The mean age was 56 years (s.d. 12.4), 54% was female, 49% was married, 74% received less than 8 years
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Ziprasidone efficacy and safety in acute bipolar mania: 12-week study
T.S. Ramey 1 *, S. Murray 2, E. Giller 1 , P. English 1 , R. Riesenberg 3, J. Trivedi 4, V.A. Tochilov 5. ]Pfizer Global
Research and Development, Department of Neuroscience, Groton, CT, USA," ePfizer Inc., Medical, USA," 3Atlanta Center for Medical Research, Bipolar Disorders, USA," 4King George "s Medical College, Department of Psychiatty, India; 5St. Petersburg State Medical Academy, Department of Psychiatty, Russian Federation Purpose: To establish the superior efficacy and tolerability o f ziprasidone versus placebo in the initial treatment o f acute bipolar mania, as well as its long-term maintenance o f effect and tolerability. Methods: 438 bipolar subjects, current episode manic or mixed, were randomized to 3 weeks' flexibly-dosed ziprasidone (40 8 0 m g BID), haloperidol (4 15 m g BID), or placebo. Placebo subjects were reassigned to ziprasidone after Week 3, and were evaluated for safety only. Subjects randomized to ziprasidone or haloperidol received treatment for less than equal to 12 weeks. The primary efficacy measure was MRS mean change from baseline to Week 3. Maintenance o f effect was the percent o f Week 3 responders who were Week 12 responders. Results: Ziprasidone was superior to placebo at Week 3 in both LOCF (P <0.01) and OC (P <0.05) analyses o f mean MRS change. Ziprasidone's effect was significant as early as Day 2, and was maintained to endpoint. 92.5% o f Week 3 ziprasidone responders were still responders at Week 12 (equivalent to haloperidol). The ziprasidone group had lower rates o f EPS at Week 12 and overall lower rates o f adverse events versus haloperidol. Conclusion: Ziprasidone effectively treated subjects with bipolar mania and maintained efficacy throughout the 12-week study. Ziprasidone was safe and well tolerated, with lower rates o f adverse events and EPS than seen with haloperidol.
•
Admissions during the climacteric period in bipolar female patients
J. Rodriguez Revuelta 1 *, G.A.V. Garcla Arroyo 2, C.G.J. Caballer Garcla 3. ]Hospital Valle del Nal6n, Asturias, Psychiatty, Gij6n,
Spain; 2Hospital fllvarez Buylla, Asturias, Spain, Psychiatty, Spain; 3Mental Health Center of Gij6n, Asturias, Spain, Psychiatty, Spain 1. S t a t e m e n t on the purpose of the study: Unlikely other affective disorders, the bipolar disorder is a pathology that appears with similar incidence in both sexes. Nevertheless, w o m e n develop more frequently bipolar disorder type II, rapid cycling, mixed episodes and switch to mania as a secondary effect o f antidepressant treatment. Based on these data, it comes up the possibility o f existing differences in the course o f bipolar disorder in w o m e n under the influence o f female sexual hormones and their variations during the reproductive cycle. The proposal is to study the possible influence o f climacteric on women, in relation to the evolution o f bipolar disorder, observing mainly the presence or absence o f severe relapse, reflected on the need o f admission in a psychiatric hospital. Admissions during the climacteric will be compared with the number o f admissions among other age groups. As a control reference is used a group o f patients not affected for climacteric, as male are.
$441
2. Methods used: It is studied a randomized sample o f 75 patients o f both sexes with bipolar disorder, inmates in the Psychiatry Unit o f Hospital Central de Asturias, Spain, from January 1984 to September 2004. It is applied the spss 11.0 statistical program. The variables studied are: Total admissions during the period studied, for both sexes. Admissions during the lapse from 45 to 55 years, theoretic period for the climacteric on women. It is also observed in males for future comparisons. Admissions o f other age groups, for both sexes. Results: Statistical differences are searched, relating the variables in twos: Total admissions confronted to admissions during the period between 45 and 55 years (climacteric o f woman) both for m e n and women. Admissions for 45 to 55 years confronted to admissions for other age groups, both for men and women. Differences among total admissions, admissions during the climacteric period and out o f that period, for both sexes. There are no statistical significant diferences among the various variables studied; all o f them showing p > 0.05.4. Conclusion: In this study it has been observed that the gender does not make specific differences on the need o f admission in a psychiatry unit for bipolar disorder. There are no statistical significant differences between men and w o m e n during the climacteric period, neither in number nor in presence or absence o f admission. Climacteric is not a risk factor for the increase o f hospital admissions.
References [1] Butt VK, Rasgon N. Special considerations in treating bipolar disorder in women. Bipolar Disord. 2004 Feb;6(1):2 13. Leibenlufi E. Women with bipolar illness: clinical and research issues. Am J Psychiatry. 1996 Feb; 153(2): 163 73.
~Mood
disorders in long-term care residential facilities
A. Placentino 1 *, E. Papa 1, S. Barreca 1 , S. Milana 1 , L. Milini 1 , C. Giovannini 1, G.B. Tura 1 , F. Madeddu 2, J. Perez 1 . ]IRCCS
Centro S.Giovanni di Dio, Biological Psychiatry Unit, Brescia, Italy; 2University of Milan-Bicocca, Psychology, Italy Purpose: M o o d disorders are leading causes o f disability and their outcomes often are worse than previously thought. Thus, we investigated the features o f affective patients needing residential care (RFs). Method: The sample consisted o f 426 patients admitted to RFs. It was assessed with the Structured Clinical Interview for D S M - I V (SCID-I and II). The severity o f symptoms was assessed by the BPRS, while the overall assessment o f functioning was obtained from the Global Assessment o f Functioning Scale (GAF, DSM-IV's axis V). The severity o f delusional features was evaluated using the Delusional Experience Rating Scale. Descriptive methods were used to examine background characteristics o f all patients. Whether the measurement o f variables was categorical or scaled, group differences were tested using chi-square or t-test. All analyses were performed using SPSS software (SPSS 11.0 for Windows). Statistical significance was determinated using 0.05 level. Results: O f the 426 subjects, 162 (38%), had a principal diagnosis o f M o o d Disorder: 82 (50%) had M D D with (N 23; 28%) or without (N 59; 72%) psychotic features; 58 (36%) had a BD-I with (N 8; 14%) or without (N 50; 86%) psychotic features and 22 (14%) had a Dysthymia. The mean age was 56 years (s.d. 12.4), 54% was female, 49% was married, 74% received less than 8 years