- Email: [email protected]
P.1.029 The influence of sertraline andmianserine on some bivalent cations in patients with major depression
Sl18
Poster Sessions
seldom - apathy and indifference. By the 14th day of treatment the fatigueability remained only in 3 patients, and apathy and indifference were absent in 66.7 percent of patients. Also by the 14th day of treatment cognitive functions improved, such as attention concentration, thinking mobility. In a number of cases, when the remission was unstable, there were narcotic break-downs, affective disorders became protracted, and the duration of paroxetine treatment rose up to 2 months, until those conditions were eliminated. More pronounced depressive disturbances required heightened doses of paroxetine 30~10 mg a day. The tolerance of the medicine by patients was good. Conclusion: the use of paroxetine proved to be very successful either in anxiety-depressive and dysphoric disorders or in apathic conditions. In general one must consider paroxetine as effective mean for the elimination of affective disorders in heroin addicted patients.
and CLBP groups, p < 0.05. The myasthenia gravis (MG) and progressive muscular dystrophy (PMD) groups had no significant differences with controls. The CTH, CLBP and TC patients groups also scored significantly higher on the 1st, 2nd, 3d, 7th and 8th SMOL scales than the control group, p <0.001. The MG patients group exhibited 1st, 2nd and 3d SMOL scales greater than the control group whereas the SMOL profile of the PMD patients group had no differences with controls. Conclusions: When compared with the healthy controls, the chronic pain and torticollis patients were significantly more likely to report the presence of anxiety and depression. The patients with neuromuscular diseases had no significant emotional stress increase in spite of their high-grade impairment and disability. The results of this study provide support for the hypothesis that brainintact patients with neuromuscular pathology have higher stress tolerance than patients with central neuromediator disturbances.
IP.1.0281 Comparison of anxiety and depression levels in patients with central nervous system disorders and patients with neuromuscular pathology
IP.1.0291 The influence of sertraline and mianserine on some bivalent cations in patients with major depression
V.N. Grigorieva, E.V. Gusanova. Nizhniy Novgorod State Medical Academy, Nizhniy Novgorod, Russia
M. Nechifor 1, C. V~ideanu 2, I. M~ndreci a, I. Palamaru 4, P. Boi~teanu2. 1Department of Pharmacology,
The aim of this study was to examine whether patients with central nervous system disorders and patients with neuromuscular pathology differ in their anxiety and depression levels. Two hundred twenty patients (Mean [M]=39.7, Standard Deviation [SDI=10.4 years) with various neurological diseases (60 patients with chronic tension headache, 72 with chronic low back pain, 51 with myasthenia gravis, 14 with progressive muscular dystrophy, 23 with torticollis and 112 healthy people of control group; M = 38.3, SD = 10.3 years) were investigated with Hospital Anxiety and Depression Scale and the SMOL test, which is a Russian brief version of the Minnesota Multiphasic Personality Inventory. Multiple comparisons were made using Student's t test and Bonferroni adjustments. Results: There were significant differences in both anxiety and depression scores between the control group (M = 6.0, SD = 3.6; M = 4.4, SD = 2.7, respectively) and the chronic tension headache (CTH) group (M = 11.3, SD=4.0; M=8.7, SD=3.7, respectively; p<0.001); between the control group and the chronic low back pain (CLBP) group (M = 8.2, SD = 14; M = 6.8, SD = 3.6, respectively; p <0.001), between the control group and the torticollis (TC) group (M=9.9, SD=4.0; M=6.1, SD=4.0, respectively; p <0.01), just as between the CTH
2Department of Psychiatry, 3Department of Biophysics, University of Medicine and Pharmacy "'Gr. T. Popa ", la~£ 4 Institute of Public Health, lafi, Romania We investigated the influence of the therapy with sertraline (Zoloft®) 100 mg/day and respective mianserine (Mianserin®) 60-80mg/day administered for 4 weeks to 18 and respective 29 patients, adults, both sexes, diagnosed with major depression, with Hamilton Rating score for Depression (HAMD) over 20, hospitalized in the Clinical Hospital of Psychiatry "Socola", Ia~i, in 2003-2004. The plasma concentrations of Cu2+, Znz+, Caz+, Mg 2+, Fe2+, erythrocyte magnesium, before and after 4 weeks of therapy were determined. The patients had no medication containing cations and had a normal diet of 2200 calories/day. Our data indicate that sertraline and mianserine raise the plasma level of zinc (mean 0.67+0.02 mg/1 before treatment and 0.96+0.03mg/1 after sertraline therapy, p <0.05 and respective 0.92+0.024mg/1 after mianserine therapy, p<0.05). The levels of other plasma cations had no significant alterations. Erythrocyte magnesium had a moderate raise, but significant (mean 4.35+0.02 mg% before therapy and 5.52+0.01 mg% after sertraline therapy, p <0.05, respective 5.67+0.03mg% after mianserine therapy, p < 0.05).
Poster Sessions We noticed plasma alterations of zinc and erythrocyte magnesium, after 4 weeks of antidepressant therapy, at the same time with clinical improvement of the depressive symptoms and a decrease of HAM:D score.
•
Double-blind, placebo-controlled, multicenter study evaluating nemifaide, a new pentapeptide antidepressant, when given daily or every other day for three weeks in the treatment of major depressive disorder
J.E Feighner, L. Sverdlov*, J. Hlavka, G. Nicolau, G. Tonelli, J. Freed. Innapharma, Inc., Park Ridge, N J,
USA Purpose: In previous Phase II clinical trials with nemifitide, significant antidepressant effect has been noted when giving 5-10 subcutaneous doses over one to three weeks. Recent preclinical experience with the Flinders Sensitive Line Rat Model (Dr. David Overstreet) demonstrates that every other day dosing is as good as daily dosing in predicting robust behavioral changes, consistent with antidepressants in this model. This new proof of principle study is designed to evaluate the efficacy of nemifitide given either daily or every other day versus placebo over a three-week treatment period in subjects diagnosed with major depressive disorder. Method: Ninety-five subjects, at six different centers (principal investigators: Drs. John Carman, Daniel Grosz, Murray Rosenthal, Raj Rajani, Ward Smith, and Michael Liebowitz) were randomized to one of three treatment groups. All subjects received 15 subcutaneous doses Monday through Friday over three weeks with 160mg of nemifitide (group 1), or placebo (group 2), or 160mg of nemifitide every other day on Monday, Wednesday and Friday with placebo doses on Tuesday and Thursday for a total of nine active doses and six placebo doses (group 3). The follow up period after the end of treatment was three weeks for assessment of clinical response. The main inclusion criteria were diagnosis of major depressive disorder according to DSM-I~, baseline MADRS ) 2 5 and CGI (severity of illness) ) 4 at screening and at baseline (pre-dose). The exclusion criteria were standard for a clinical trial for major depression. The primary efficacy variable was MADRS (change from baseline). The secondary efficacy variables were HAMD-17, Carroll Self-Rating Depression Scale and CGI. The safety profile was based on adverse events, concomitant medication, vital signs, physical exams, ECG, and clinical laboratory evaluations.
Sl19
Results: The study demonstrated the statistical superiority of the 160mg dose of nemifitide given every other day over placebo on multiple ratings scales at multiple time points throughout the study. The 160mg dose of nemifitide given daily Monday through Friday for three weeks was not significant in separating from placebo. Safety results provided no evidence of significant adverse events associated with the administration of nemifitide and the side effects from nemifitide were comparable to those from placebo, There were no dropouts because of significant side effects. Conclusions: Data from this new proof of principle clinical trial provides confirmation that nemifitide has the potential to be a safe and effective antidepressant drug. The results from this study support every other day dosing of 160 mg of nemifitide over three consecutive weeks to be an effective regimen.
IP.1.0311 Use of sibutramine, an inhibitor of the reuptake of serotonin and noradrenaline, in the treatment of binge eating disorder: a placebo.controlled study A. Casella 1, W. Milano 2, C. Petrella2, A. Capasso 1.
1Department of Pharmaceutical Sciences, University of Salerno, ltaly," eMental Health Operations Unit District 44 ASL Napoli 1, Italy Binge-eating disorder (BED) is characterized by uncontrolled eating of large amounts of food. The differentiating characteristic between this disorder and bulimia nervosa is that patients do not follow binge eating with compensatory behaviors such as self-induced vomiting. Binge-eating disorder is common in patients who seek treatment for obesity. Persons with this disorder have higher rates of comorbid psychiatric disorders, especially depression. Treatment goals for patients who suffer from comorbid psychiatric disorder. A new serotonin and norepinephrine reuptake inhibitor, sibutramine, has been shown to be effective in weight reduction and maintenance programs in short- and long-term studies. In the present study we evaluated the efficacy and safety of sibutramine in the treatment of patients with binge-eating disorder. The trial was a randomized, double-blind, placebo-controlled study of patients who met the criteria for binge-eating disorder in the Diagnostic and Statistical Manual of Mental Disorders, 4th ed., and also met the defnition of obesity based on their body mass index. Patients who met the inclusion criteria were randomly assigned to receive sibutramine in a dosage of 10mg per day or placebo for
Poster Sessions
seldom - apathy and indifference. By the 14th day of treatment the fatigueability remained only in 3 patients, and apathy and indifference were absent in 66.7 percent of patients. Also by the 14th day of treatment cognitive functions improved, such as attention concentration, thinking mobility. In a number of cases, when the remission was unstable, there were narcotic break-downs, affective disorders became protracted, and the duration of paroxetine treatment rose up to 2 months, until those conditions were eliminated. More pronounced depressive disturbances required heightened doses of paroxetine 30~10 mg a day. The tolerance of the medicine by patients was good. Conclusion: the use of paroxetine proved to be very successful either in anxiety-depressive and dysphoric disorders or in apathic conditions. In general one must consider paroxetine as effective mean for the elimination of affective disorders in heroin addicted patients.
and CLBP groups, p < 0.05. The myasthenia gravis (MG) and progressive muscular dystrophy (PMD) groups had no significant differences with controls. The CTH, CLBP and TC patients groups also scored significantly higher on the 1st, 2nd, 3d, 7th and 8th SMOL scales than the control group, p <0.001. The MG patients group exhibited 1st, 2nd and 3d SMOL scales greater than the control group whereas the SMOL profile of the PMD patients group had no differences with controls. Conclusions: When compared with the healthy controls, the chronic pain and torticollis patients were significantly more likely to report the presence of anxiety and depression. The patients with neuromuscular diseases had no significant emotional stress increase in spite of their high-grade impairment and disability. The results of this study provide support for the hypothesis that brainintact patients with neuromuscular pathology have higher stress tolerance than patients with central neuromediator disturbances.
IP.1.0281 Comparison of anxiety and depression levels in patients with central nervous system disorders and patients with neuromuscular pathology
IP.1.0291 The influence of sertraline and mianserine on some bivalent cations in patients with major depression
V.N. Grigorieva, E.V. Gusanova. Nizhniy Novgorod State Medical Academy, Nizhniy Novgorod, Russia
M. Nechifor 1, C. V~ideanu 2, I. M~ndreci a, I. Palamaru 4, P. Boi~teanu2. 1Department of Pharmacology,
The aim of this study was to examine whether patients with central nervous system disorders and patients with neuromuscular pathology differ in their anxiety and depression levels. Two hundred twenty patients (Mean [M]=39.7, Standard Deviation [SDI=10.4 years) with various neurological diseases (60 patients with chronic tension headache, 72 with chronic low back pain, 51 with myasthenia gravis, 14 with progressive muscular dystrophy, 23 with torticollis and 112 healthy people of control group; M = 38.3, SD = 10.3 years) were investigated with Hospital Anxiety and Depression Scale and the SMOL test, which is a Russian brief version of the Minnesota Multiphasic Personality Inventory. Multiple comparisons were made using Student's t test and Bonferroni adjustments. Results: There were significant differences in both anxiety and depression scores between the control group (M = 6.0, SD = 3.6; M = 4.4, SD = 2.7, respectively) and the chronic tension headache (CTH) group (M = 11.3, SD=4.0; M=8.7, SD=3.7, respectively; p<0.001); between the control group and the chronic low back pain (CLBP) group (M = 8.2, SD = 14; M = 6.8, SD = 3.6, respectively; p <0.001), between the control group and the torticollis (TC) group (M=9.9, SD=4.0; M=6.1, SD=4.0, respectively; p <0.01), just as between the CTH
2Department of Psychiatry, 3Department of Biophysics, University of Medicine and Pharmacy "'Gr. T. Popa ", la~£ 4 Institute of Public Health, lafi, Romania We investigated the influence of the therapy with sertraline (Zoloft®) 100 mg/day and respective mianserine (Mianserin®) 60-80mg/day administered for 4 weeks to 18 and respective 29 patients, adults, both sexes, diagnosed with major depression, with Hamilton Rating score for Depression (HAMD) over 20, hospitalized in the Clinical Hospital of Psychiatry "Socola", Ia~i, in 2003-2004. The plasma concentrations of Cu2+, Znz+, Caz+, Mg 2+, Fe2+, erythrocyte magnesium, before and after 4 weeks of therapy were determined. The patients had no medication containing cations and had a normal diet of 2200 calories/day. Our data indicate that sertraline and mianserine raise the plasma level of zinc (mean 0.67+0.02 mg/1 before treatment and 0.96+0.03mg/1 after sertraline therapy, p <0.05 and respective 0.92+0.024mg/1 after mianserine therapy, p<0.05). The levels of other plasma cations had no significant alterations. Erythrocyte magnesium had a moderate raise, but significant (mean 4.35+0.02 mg% before therapy and 5.52+0.01 mg% after sertraline therapy, p <0.05, respective 5.67+0.03mg% after mianserine therapy, p < 0.05).
Poster Sessions We noticed plasma alterations of zinc and erythrocyte magnesium, after 4 weeks of antidepressant therapy, at the same time with clinical improvement of the depressive symptoms and a decrease of HAM:D score.
•
Double-blind, placebo-controlled, multicenter study evaluating nemifaide, a new pentapeptide antidepressant, when given daily or every other day for three weeks in the treatment of major depressive disorder
J.E Feighner, L. Sverdlov*, J. Hlavka, G. Nicolau, G. Tonelli, J. Freed. Innapharma, Inc., Park Ridge, N J,
USA Purpose: In previous Phase II clinical trials with nemifitide, significant antidepressant effect has been noted when giving 5-10 subcutaneous doses over one to three weeks. Recent preclinical experience with the Flinders Sensitive Line Rat Model (Dr. David Overstreet) demonstrates that every other day dosing is as good as daily dosing in predicting robust behavioral changes, consistent with antidepressants in this model. This new proof of principle study is designed to evaluate the efficacy of nemifitide given either daily or every other day versus placebo over a three-week treatment period in subjects diagnosed with major depressive disorder. Method: Ninety-five subjects, at six different centers (principal investigators: Drs. John Carman, Daniel Grosz, Murray Rosenthal, Raj Rajani, Ward Smith, and Michael Liebowitz) were randomized to one of three treatment groups. All subjects received 15 subcutaneous doses Monday through Friday over three weeks with 160mg of nemifitide (group 1), or placebo (group 2), or 160mg of nemifitide every other day on Monday, Wednesday and Friday with placebo doses on Tuesday and Thursday for a total of nine active doses and six placebo doses (group 3). The follow up period after the end of treatment was three weeks for assessment of clinical response. The main inclusion criteria were diagnosis of major depressive disorder according to DSM-I~, baseline MADRS ) 2 5 and CGI (severity of illness) ) 4 at screening and at baseline (pre-dose). The exclusion criteria were standard for a clinical trial for major depression. The primary efficacy variable was MADRS (change from baseline). The secondary efficacy variables were HAMD-17, Carroll Self-Rating Depression Scale and CGI. The safety profile was based on adverse events, concomitant medication, vital signs, physical exams, ECG, and clinical laboratory evaluations.
Sl19
Results: The study demonstrated the statistical superiority of the 160mg dose of nemifitide given every other day over placebo on multiple ratings scales at multiple time points throughout the study. The 160mg dose of nemifitide given daily Monday through Friday for three weeks was not significant in separating from placebo. Safety results provided no evidence of significant adverse events associated with the administration of nemifitide and the side effects from nemifitide were comparable to those from placebo, There were no dropouts because of significant side effects. Conclusions: Data from this new proof of principle clinical trial provides confirmation that nemifitide has the potential to be a safe and effective antidepressant drug. The results from this study support every other day dosing of 160 mg of nemifitide over three consecutive weeks to be an effective regimen.
IP.1.0311 Use of sibutramine, an inhibitor of the reuptake of serotonin and noradrenaline, in the treatment of binge eating disorder: a placebo.controlled study A. Casella 1, W. Milano 2, C. Petrella2, A. Capasso 1.
1Department of Pharmaceutical Sciences, University of Salerno, ltaly," eMental Health Operations Unit District 44 ASL Napoli 1, Italy Binge-eating disorder (BED) is characterized by uncontrolled eating of large amounts of food. The differentiating characteristic between this disorder and bulimia nervosa is that patients do not follow binge eating with compensatory behaviors such as self-induced vomiting. Binge-eating disorder is common in patients who seek treatment for obesity. Persons with this disorder have higher rates of comorbid psychiatric disorders, especially depression. Treatment goals for patients who suffer from comorbid psychiatric disorder. A new serotonin and norepinephrine reuptake inhibitor, sibutramine, has been shown to be effective in weight reduction and maintenance programs in short- and long-term studies. In the present study we evaluated the efficacy and safety of sibutramine in the treatment of patients with binge-eating disorder. The trial was a randomized, double-blind, placebo-controlled study of patients who met the criteria for binge-eating disorder in the Diagnostic and Statistical Manual of Mental Disorders, 4th ed., and also met the defnition of obesity based on their body mass index. Patients who met the inclusion criteria were randomly assigned to receive sibutramine in a dosage of 10mg per day or placebo for