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Safety and pharmacokinetics following a single oral dose of amisulpride administered in healthy elderly
BIOL. PSYCHIATRY
Poster session ill
1997;42:15-2975
IiSt8Ill confusion. The patient underwent a thorough laboratory Investigation wtlic:h revealed the presence of autoantibodieS (antinuclear, anti-DNA) and serum immunoglobulin abnonnalities (decreased levels of serum IgA). These i'\'lITlUIlOIOIical abnonnalities persisted during follow-up. Condullon: It Is suggested that an underlying Immunological disturbance mtiI'f be related to the clinical manifestations of NMS or that both abnormalities are • oonsequence of exposure to neuroleptic drugs.
[65-98]
Effects of clozaplne on avolition-apathy and anhedonla-asoclality In schizophrenic patients
E. zanaJda. G. Brunetti, M. Scotia, M. Mazzucco, F. Bogetto, L. Ravlzza. Departm8fIf of Neuroscience, Psychiatric Clinic. University of Turin. Italy In treatment resistant patients clozaplne has been shown to exert a useful elIect In abOUt 50"10. It Is a significant Improvement which may contribute to a bell8f quality of life. whether in Institution or in society in short and long tenn
c:inIC8I stUdies. Clozapine has a definitive advantage over traditional neu•
ItlIeptiC In regard to acute and chronic extrapyramidal side effects. Clozapine mtiI'f or may not Improve cognitive functions and primary negative symptoms. The58 are controVersial Issues which are under examination and debate. QI purpose was to evaluate the effects of clozapine on negative symptoms d JChiZOPhrenic patients with prominent negative symptomatology. lMthodl: Fourteen neuroleptic resistant schizophrenic patients with ptlITlInerll negative symptoms were treated for one year with clozaplne. SIX out of them were females and 8 males; mean age was about 32 years with 17 to 49 as range. According to the DSM-IV patients were distributed ~ 1h8 folIoWlng schizophrenia subtypes: 11 undifferentiated and 3 residual. A mean doS8 of c10zaplne was 250 mg daily. All patients were assessed by IlafldaIdized clinical evaluation. ResUltS: Global score reduction on the Scale for the Assessment of NegatiVe symptoms (SANS) was observed alter at least six months of treat• ment. bUt It was not statistically significant. Analyzing the single SANS items . . obseI'Ved that avolition-apathy and anhedonia-asoclality significantly 1m• poved. Improvement In such symptoms could be reflected in other areas l::onsidef'ed as outcome measures In schizophrenia long tenn treatment. Our hypOtheSis Is that Improvement In avolltion-apathy and anhedonla-asociality is due to a direct effect of clozaplne. All patients showed a good tolerability
to treatmenL (65-9~ safety and pharmacokinetics following a single oral dose of amlsulprlde administered In healthy elderly
B Ha/TlOIl'"Vllcot 2, S. Chaufour 1 , C. Deschamps " M. Canal 1 , p.' Chretien'. F. Pielte 2. P. Rosenzweig '. 1 Synthe/abo Recherche,
s,pux. France. 2 H6pital Charles Foix. Ivry. France, 3 Cemax. Rouen.
Frara
ArniIUIpr!d8 Is a substituted benzamide neuroleptic which binds selectively 10 the dc)p8ITline 02 and 03 receptors, mainly in the limbic and hippocampal
~ of neuroleptlcs In the elderly may be necessary. Therefore the . of this .tudY was to detennlne the safety and the phannacokinetic (PK) 01 50 mg of amlsulprlde administered orally as a single dose to the
::-1Ie
ISIS
I male sexual functions at masturbation
165-100 The Impact of neuroleptic maintenance therapy on P.B. Kores, B. zalar. University Psychiatric Clinic. StucJenec 48 1260 Ljubljana-Polje, Slovenia ' ~en, who receive neuroleptic therapy often complain about sexual dysfunc• liOns. In this work sexual functions and dysfunctions at masturbation are p~esented bot~ in males who received long tenn neuroleptic treatment either With fluphenazine, haloperidol or zuclopenthlxol depot, and In healthy males. Methods: We assessed sexual functions and dysfunctions at masturbation In the group of 59 patients before and during neuroleptic maintenance treatment and In the group of 25 healthy men. Questioners adjusted for this survey were used, as w~II as MMPlfor assessing the validity of answers. Data have been calculated With parametrical Kruskal-Wallis and/or Mann-Whitney statistical techniques. Results: The frequency of masturbation was higher before the treatment (89"10) and In.l!Je healthy controls (97%). During long term therapy there were more .dlfflcultl.es (p < 0.05) in obtaining erection, there were more orgasms Without ejaculation (p < 0.05), painfUl ejaculations (p < 0.05) and white urine-retrograde ejaculations (p < 0.05) than in the time before maintenance neuroleptic treatment and In control group. Partnership or the lack ~f partnership was without any influence on sexual functions at masturbatlo~. We could not prove the influence either of neuroleptic type or of neuroleptiC dosage on sexual function at masturbation. The presence of sexual dysfunctions is also Influenced by the criticalness of selfassessment In both groups and by the absence of objective methods of assessing sexual functions.
I
165-101 A pharmacological, psychotherapeutic and psychosocial approach In psychosis: A long term study with risperldone
M.e. Ma~ri, .A. Arduini, E. Critel~i,. R. Rosselli, V. Lalnl, M. Mondino, G. InvemlZZI. Department of Clinical Psychiatry. IRCCS Ospedale Maggiore di Milano, Clinical Neuropsychopharrnacology Unit Milan Italy. USSL 36. centro Psicosociale, Milan. Italy •• • The eff~eness of treatment of psychotic patients with risperidone (RSP) together With psychosocial and psychotherapeutic support has been evalu• ated. Methods: 18 outpatients with average 41.8 ± 12.16 SO affected by Undll• ferentiad Schizophrenia (OSM IV) with a prevalence of negative symptoms a~or behavioural abnonnalities and aggressiveness wene studied. Th~ pa~lents have been treated with RSP at a dosage ranging from 2 to 6 mg dally (mean 4.17 mg ± 1.19 SO) for 9 months. At the and of the study plasma levels of the d~g and Its active metabolite hydroxl-risperidone wer~ perlonned. T~e~her With the phannacologlcal therapy, psychotherapeutic and/or re.h~dltetive tre~tment was administered. Patients were evaluated from a clinical perspective and side effects on the SPRS, PANSS EPSE ACS scales. ' , Results: Patients showed a significant decrease In the scores of the evaluations scales, showing a good tollerance to the drug. The joint ap• proach, phannacotherapy-psych?the~peutic and/or psychosocial support tumed out to be effectIVe, especially In those pathologies characterized by autistic withdrawal and behavioral abnonnallties.
IIlderlY subjectS. TwentY healtl1Y volunters aged 65-79 years (10 men and 10 women) free d mediC8tlon have participated to this open study. Adverse event recording, wllaI signS. ECG and blood samples were perlonned up to 72 hours after drug ;rtake.
The overall clinical and cardiovascular safety were satisfactory. Pariculariy, xtraPYf8nIldai symptoms were observed. The PK parameters were in the ~ 01 thOS8 obtained In healthy young volunteers (reference population). 1",.. Cmax 1,/2 (h) (ng ml-1) (h)
AUC (0-00) Dose excreted un(ng ml-1 h) changed In urine (%ol
2.
64.1:1: 8.7 15.8:1: 1.3 667:1: 51
12.2:1: 1. t
~popuIlItion 3·
58.0:1:4.1 11.7:1:0.5603:1:25
21.0:1:1.1
8lI6ed popuI8ti011 .... 54)
•. . - - vaJulI· Ih8 baSis of these data, no dosage adjustment seems to be necessary fer~Ipride In short tenn treatments In elderly with nonnal nenal function.
165-1021 Long-term study of amisuipride In the treatment of schizophrenia L Col~nna 1 , E. Guerault 2, S. Tu~anski 2. 1 C.H.S. du Rouvray. Soltev1lIe-/es-Rouen, France, 2 Synlhelabo. Le Plessis-Robinson. France Amisulp.ride (AMI), a substiMed benzamlde, is an atypical antipsychotic with a sel~lve high affinity f~r .the dopamine 02 and 03 receptors, preferentially in limbiC areas. The pnellmlnary nesults of an Intemational open randomised, 12-months stu?y will ~ p~esented: 197 patients aged 18 to 65 years, presenting schizophrenia With acute exacerbation (DSM III-R criteria) were randomised (196 were exposed to the study drug: 3AMU1 HAL). 147 patients were treated with AMI: 200 to 800 mgld (max: 1200 mgld), and 49 with HAL: 5 to 20 m.g1d (max:: 30 mgld). 70"10 of the patients were male and 920/0 had a chronic disease With a mean duration of the Illness of12 ± 8.2 years. 39% of the. AMI, and 36% in the HAL patients completed the study. The number of patients with at least one emergent adverse event was similar in both groups' 60% in the AMI and 65% in the HAL group. The most frequently reported adverse events were extrapyramidal symptoms (EPS). In the HAL group,
Poster session ill
1997;42:15-2975
IiSt8Ill confusion. The patient underwent a thorough laboratory Investigation wtlic:h revealed the presence of autoantibodieS (antinuclear, anti-DNA) and serum immunoglobulin abnonnalities (decreased levels of serum IgA). These i'\'lITlUIlOIOIical abnonnalities persisted during follow-up. Condullon: It Is suggested that an underlying Immunological disturbance mtiI'f be related to the clinical manifestations of NMS or that both abnormalities are • oonsequence of exposure to neuroleptic drugs.
[65-98]
Effects of clozaplne on avolition-apathy and anhedonla-asoclality In schizophrenic patients
E. zanaJda. G. Brunetti, M. Scotia, M. Mazzucco, F. Bogetto, L. Ravlzza. Departm8fIf of Neuroscience, Psychiatric Clinic. University of Turin. Italy In treatment resistant patients clozaplne has been shown to exert a useful elIect In abOUt 50"10. It Is a significant Improvement which may contribute to a bell8f quality of life. whether in Institution or in society in short and long tenn
c:inIC8I stUdies. Clozapine has a definitive advantage over traditional neu•
ItlIeptiC In regard to acute and chronic extrapyramidal side effects. Clozapine mtiI'f or may not Improve cognitive functions and primary negative symptoms. The58 are controVersial Issues which are under examination and debate. QI purpose was to evaluate the effects of clozapine on negative symptoms d JChiZOPhrenic patients with prominent negative symptomatology. lMthodl: Fourteen neuroleptic resistant schizophrenic patients with ptlITlInerll negative symptoms were treated for one year with clozaplne. SIX out of them were females and 8 males; mean age was about 32 years with 17 to 49 as range. According to the DSM-IV patients were distributed ~ 1h8 folIoWlng schizophrenia subtypes: 11 undifferentiated and 3 residual. A mean doS8 of c10zaplne was 250 mg daily. All patients were assessed by IlafldaIdized clinical evaluation. ResUltS: Global score reduction on the Scale for the Assessment of NegatiVe symptoms (SANS) was observed alter at least six months of treat• ment. bUt It was not statistically significant. Analyzing the single SANS items . . obseI'Ved that avolition-apathy and anhedonia-asoclality significantly 1m• poved. Improvement In such symptoms could be reflected in other areas l::onsidef'ed as outcome measures In schizophrenia long tenn treatment. Our hypOtheSis Is that Improvement In avolltion-apathy and anhedonla-asociality is due to a direct effect of clozaplne. All patients showed a good tolerability
to treatmenL (65-9~ safety and pharmacokinetics following a single oral dose of amlsulprlde administered In healthy elderly
B Ha/TlOIl'"Vllcot 2, S. Chaufour 1 , C. Deschamps " M. Canal 1 , p.' Chretien'. F. Pielte 2. P. Rosenzweig '. 1 Synthe/abo Recherche,
s,pux. France. 2 H6pital Charles Foix. Ivry. France, 3 Cemax. Rouen.
Frara
ArniIUIpr!d8 Is a substituted benzamide neuroleptic which binds selectively 10 the dc)p8ITline 02 and 03 receptors, mainly in the limbic and hippocampal
~ of neuroleptlcs In the elderly may be necessary. Therefore the . of this .tudY was to detennlne the safety and the phannacokinetic (PK) 01 50 mg of amlsulprlde administered orally as a single dose to the
::-1Ie
ISIS
I male sexual functions at masturbation
165-100 The Impact of neuroleptic maintenance therapy on P.B. Kores, B. zalar. University Psychiatric Clinic. StucJenec 48 1260 Ljubljana-Polje, Slovenia ' ~en, who receive neuroleptic therapy often complain about sexual dysfunc• liOns. In this work sexual functions and dysfunctions at masturbation are p~esented bot~ in males who received long tenn neuroleptic treatment either With fluphenazine, haloperidol or zuclopenthlxol depot, and In healthy males. Methods: We assessed sexual functions and dysfunctions at masturbation In the group of 59 patients before and during neuroleptic maintenance treatment and In the group of 25 healthy men. Questioners adjusted for this survey were used, as w~II as MMPlfor assessing the validity of answers. Data have been calculated With parametrical Kruskal-Wallis and/or Mann-Whitney statistical techniques. Results: The frequency of masturbation was higher before the treatment (89"10) and In.l!Je healthy controls (97%). During long term therapy there were more .dlfflcultl.es (p < 0.05) in obtaining erection, there were more orgasms Without ejaculation (p < 0.05), painfUl ejaculations (p < 0.05) and white urine-retrograde ejaculations (p < 0.05) than in the time before maintenance neuroleptic treatment and In control group. Partnership or the lack ~f partnership was without any influence on sexual functions at masturbatlo~. We could not prove the influence either of neuroleptic type or of neuroleptiC dosage on sexual function at masturbation. The presence of sexual dysfunctions is also Influenced by the criticalness of selfassessment In both groups and by the absence of objective methods of assessing sexual functions.
I
165-101 A pharmacological, psychotherapeutic and psychosocial approach In psychosis: A long term study with risperldone
M.e. Ma~ri, .A. Arduini, E. Critel~i,. R. Rosselli, V. Lalnl, M. Mondino, G. InvemlZZI. Department of Clinical Psychiatry. IRCCS Ospedale Maggiore di Milano, Clinical Neuropsychopharrnacology Unit Milan Italy. USSL 36. centro Psicosociale, Milan. Italy •• • The eff~eness of treatment of psychotic patients with risperidone (RSP) together With psychosocial and psychotherapeutic support has been evalu• ated. Methods: 18 outpatients with average 41.8 ± 12.16 SO affected by Undll• ferentiad Schizophrenia (OSM IV) with a prevalence of negative symptoms a~or behavioural abnonnalities and aggressiveness wene studied. Th~ pa~lents have been treated with RSP at a dosage ranging from 2 to 6 mg dally (mean 4.17 mg ± 1.19 SO) for 9 months. At the and of the study plasma levels of the d~g and Its active metabolite hydroxl-risperidone wer~ perlonned. T~e~her With the phannacologlcal therapy, psychotherapeutic and/or re.h~dltetive tre~tment was administered. Patients were evaluated from a clinical perspective and side effects on the SPRS, PANSS EPSE ACS scales. ' , Results: Patients showed a significant decrease In the scores of the evaluations scales, showing a good tollerance to the drug. The joint ap• proach, phannacotherapy-psych?the~peutic and/or psychosocial support tumed out to be effectIVe, especially In those pathologies characterized by autistic withdrawal and behavioral abnonnallties.
IIlderlY subjectS. TwentY healtl1Y volunters aged 65-79 years (10 men and 10 women) free d mediC8tlon have participated to this open study. Adverse event recording, wllaI signS. ECG and blood samples were perlonned up to 72 hours after drug ;rtake.
The overall clinical and cardiovascular safety were satisfactory. Pariculariy, xtraPYf8nIldai symptoms were observed. The PK parameters were in the ~ 01 thOS8 obtained In healthy young volunteers (reference population). 1",.. Cmax 1,/2 (h) (ng ml-1) (h)
AUC (0-00) Dose excreted un(ng ml-1 h) changed In urine (%ol
2.
64.1:1: 8.7 15.8:1: 1.3 667:1: 51
12.2:1: 1. t
~popuIlItion 3·
58.0:1:4.1 11.7:1:0.5603:1:25
21.0:1:1.1
8lI6ed popuI8ti011 .... 54)
•. . - - vaJulI· Ih8 baSis of these data, no dosage adjustment seems to be necessary fer~Ipride In short tenn treatments In elderly with nonnal nenal function.
165-1021 Long-term study of amisuipride In the treatment of schizophrenia L Col~nna 1 , E. Guerault 2, S. Tu~anski 2. 1 C.H.S. du Rouvray. Soltev1lIe-/es-Rouen, France, 2 Synlhelabo. Le Plessis-Robinson. France Amisulp.ride (AMI), a substiMed benzamlde, is an atypical antipsychotic with a sel~lve high affinity f~r .the dopamine 02 and 03 receptors, preferentially in limbiC areas. The pnellmlnary nesults of an Intemational open randomised, 12-months stu?y will ~ p~esented: 197 patients aged 18 to 65 years, presenting schizophrenia With acute exacerbation (DSM III-R criteria) were randomised (196 were exposed to the study drug: 3AMU1 HAL). 147 patients were treated with AMI: 200 to 800 mgld (max: 1200 mgld), and 49 with HAL: 5 to 20 m.g1d (max:: 30 mgld). 70"10 of the patients were male and 920/0 had a chronic disease With a mean duration of the Illness of12 ± 8.2 years. 39% of the. AMI, and 36% in the HAL patients completed the study. The number of patients with at least one emergent adverse event was similar in both groups' 60% in the AMI and 65% in the HAL group. The most frequently reported adverse events were extrapyramidal symptoms (EPS). In the HAL group,