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Olanzapine vs. Risperidone in Treating Aggressive Behaviours in Adults with Intellectual Disability: A Single Blind Study

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Title: Olanzapine vs. Risperidone in Treating Aggressive Behaviours in Adults with Intellectual Disability: A Single Blind Study
Language: English
Authors: Amore, M., Bertelli, M., Villani, D., Tamborini, S., Rossi, M.
Source: Journal of Intellectual Disability Research. Feb 2011 55(2):210-218.
Availability: Wiley-Blackwell. 350 Main Street, Malden, MA 02148. Tel: 800-835-6770; Tel: 781-388-8598; Fax: 781-388-8232; e-mail: cs-journals@wiley.com; Web site: http://www.wiley.com/WileyCDA/
Peer Reviewed: Y
Page Count: 9
Publication Date: 2011
Document Type: Journal Articles
Reports - Research
Descriptors: Mental Retardation, Measures (Individuals), Program Effectiveness, Statistical Analysis, Drug Therapy, Aggression, Behavior Modification, Adults, Symptoms (Individual Disorders), Outcomes of Treatment
DOI: 10.1111/j.1365-2788.2010.01352.x
ISSN: 0964-2633
Abstract: Background: Aggressive behaviour represents a frequent symptom in people with intellectual disability (PWID). Despite uncertain evidence of effectiveness, the use of antipsychotics (APs) drugs to treat aggressive behaviour is very common. Antipsychotic medication of aggressivity in PWID has recently become one of the most debated issues in mental health and the need of further research is persistently stressed by most researchers. Aim: The present study was firstly aimed at evaluating the effectiveness (efficacy on target behaviour, safety and persistence on treatment) of new generation APs, in particular, olanzapine and risperidone in treating aggressive behaviour in PWID for who previous medication with first generation APs (FGAs) were not effective. Methods: 62 subjects with intellectual disability underwent to a 2-arm, parallel group pragmatic trial of olanzapine and risperidone with balanced randomisation and blind assessment of outcome at 4, 8, 12, 16, 20 and 24 weeks after a switch (cross-tapering) from a 24-week treatment with FGAs. Aggressive behaviours were assessed by Overt Aggression Scale (OAS) and clinical outcome by Clinical Global Impression Scale. Side effects were assessed with Dosage Record and Treatment Emergent Symptoms Scale, other symptom-specific scales, laboratory and instrumental tests. Results: Both risperidone and olanzapine resulted to be more effective than FGAs in reducing aggressive behaviour. Repeated-measures analysis of covariance revealed that treatment groups differed for cumulative number of aggressive episodes during the FGAs treatment, which was higher for olanzapine. Conclusion: Our findings seem to confirm that olanzapine and risperidone can be effective in reducing aggressive behaviour in PWID. Both compounds resulted to be well tolerated, with side effects similar to those encountered in other patient populations.
Abstractor: As Provided
Number of References: 35
Entry Date: 2011
Accession Number: EJ927747
Database: ERIC
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  Value: <anid>AN0057367125;eul01feb.11;2019Jun04.10:45;v2.2.500</anid> <title id="AN0057367125-1">Olanzapine vs. risperidone in treating aggressive behaviours in adults with intellectual disability: a single blind study. </title> <p>Background  Aggressive behaviour represents a frequent symptom in people with intellectual disability (PWID). Despite uncertain evidence of effectiveness, the use of antipsychotics (APs) drugs to treat aggressive behaviour is very common. Antipsychotic medication of aggressivity in PWID has recently become one of the most debated issues in mental health and the need of further research is persistently stressed by most researchers. Aim  The present study was firstly aimed at evaluating the effectiveness (efficacy on target behaviour, safety and persistence on treatment) of new generation APs, in particular, olanzapine and risperidone in treating aggressive behaviour in PWID for who previous medication with first generation APs (FGAs) were not effective. Methods  62 subjects with intellectual disability underwent to a 2‐arm, parallel group pragmatic trial of olanzapine and risperidone with balanced randomisation and blind assessment of outcome at 4, 8, 12, 16, 20 and 24 weeks after a switch (cross‐tapering) from a 24‐week treatment with FGAs. Aggressive behaviours were assessed by Overt Aggression Scale (OAS) and clinical outcome by Clinical Global Impression Scale. Side effects were assessed with Dosage Record and Treatment Emergent Symptoms Scale, other symptom‐specific scales, laboratory and instrumental tests. Results  Both risperidone and olanzapine resulted to be more effective than FGAs in reducing aggressive behaviour. Repeated‐measures analysis of covariance revealed that treatment groups differed for cumulative number of aggressive episodes during the FGAs treatment, which was higher for olanzapine. Conclusion  Our findings seem to confirm that olanzapine and risperidone can be effective in reducing aggressive behaviour in PWID. Both compounds resulted to be well tolerated, with side effects similar to those encountered in other patient populations.</p> <p>Keywords: antipsychotics; atypical; intellectual disability; olanzapine; risperidone; aggressive behaviour</p> <hd id="AN0057367125-2">Aggressive behaviours in people with intellectual disability (PWID)</hd> <p>Behavioural problems (BPs) represent the most frequent issue in multidisciplinary staff's everyday practice on people with intellectual disability (PWID). The literature reports a prevalence varying from 5% to 60% in dependence on the definition of BPs ([<reflink idref="bib26" id="ref1">26</reflink>]). Among BPs, aggressive behaviour seems to be the most important one, because it shows a high prevalence and can be quite dangerous for the person itself or the social environment. It is well considered in the literature and generally classified by object of orientation: verbal or physical (towards other persons), destructive (towards objects) and self‐injury.</p> <p>The presentation of BPs is determined by a complexity of factors. The pathogenic contribution of organic conditions, psychiatric disorders, environmental influences or a combination of these, has to be carefully established for every single case. A coordinated effort of a multidisciplinary team also affords the most comprehensive and efficacious method of planning and managing treatment of BPs and associated psychiatric pathology in individuals across the range of ID ([<reflink idref="bib12" id="ref2">12</reflink>]).</p> <hd id="AN0057367125-3">Antipsychotics drugs for the treatment of aggressive behaviour in PWID</hd> <p>Despite uncertain evidence of effectiveness, the use of antipsychotics (APs) drugs to treat aggressive behaviour is very common. Some studies show that around 20% of PWID in community settings ([<reflink idref="bib7" id="ref3">7</reflink>]; [<reflink idref="bib15" id="ref4">15</reflink>]) and 40% of those in hospital ([<reflink idref="bib19" id="ref5">19</reflink>]) receive at least one AP. [<reflink idref="bib31" id="ref6">31</reflink>]) have recently reported that placebo can work better than haloperidol or risperidone in controlling pervasivity and intensity of aggressive behaviours in adults with ID. On the other hand, many authors found that new generation antipsychotics (NGAs) can be effectively utilised across the lifespan, from childhood ([<reflink idref="bib2" id="ref7">2</reflink>]; [<reflink idref="bib27" id="ref8">27</reflink>]; [<reflink idref="bib30" id="ref9">30</reflink>]) to adolescence ([<reflink idref="bib9" id="ref10">9</reflink>]), and adulthood ([<reflink idref="bib14" id="ref11">14</reflink>]; [<reflink idref="bib21" id="ref12">21</reflink>]; [<reflink idref="bib35" id="ref13">35</reflink>]; [<reflink idref="bib20" id="ref14">20</reflink>]; [<reflink idref="bib6" id="ref15">6</reflink>]; [<reflink idref="bib16" id="ref16">16</reflink>]). Among NGAs, clozapine, risperidone and olanzapine resulted to be the most used and studied ([<reflink idref="bib18" id="ref17">18</reflink>]). In respect to haloperidol and other first generation antipsychotics (FGAs), NGAs have different receptors profile with a quite lower negative impact on those systems that are more vulnerable in PWID, such as neuro‐motor or cognitive ones. Antipsychotic medication of aggressive behaviour in PWID has recently become one of the most debated issues in mental health and the need of further research is persistently stressed by most researchers.</p> <hd id="AN0057367125-4">Aims</hd> <p>The present study was firstly aimed at evaluating the effectiveness (efficacy on target behaviour, safety and persistence on treatment) of olanzapine vs. risperidone in treating aggressive behaviours in PWID for whom previous medication with FGAs was not effective.</p> <p>As far as we could find in the literature, this is the third study on the comparison of these two NGAs. The previous ones were conducted by [<reflink idref="bib33" id="ref18">33</reflink>]) and followed on by [<reflink idref="bib6" id="ref19">6</reflink>]).</p> <hd id="AN0057367125-5">Methods</hd> <p></p> <hd id="AN0057367125-6">Study design</hd> <p>The study was a two‐arm, parallel group pragmatic trial of olanzapine and risperidone with balanced randomisation and blind assessment of outcome at 4, 8, 12, 16, 20 and 24 weeks after a switch (cross‐tapering) from a 24‐week treatment with FGAs.</p> <hd id="AN0057367125-7">Sample</hd> <p>Participants in the study were consecutive patients attending a specialist mental health service for PWID (Istituto Ospedaliero 'Fondazione Sospiro' di Sospiro – Cremona) covering an area of 154 677 inhabitants of the North Italy. A total of 62 adults (mean age of 48 ± 12.45 years), of which 17 were female (27.4%) and 45 male (72.6%), were recruited to the study between November 2005 and December 2006 from a catchment area of approximately 800 users. Subjects in the study were in residential care, with Diagnostic and Statistic Manual‐IV Edition Text Revision (DSM‐IV TR) ([<reflink idref="bib3" id="ref20">3</reflink>]) diagnosis of Severe Mental Retardation (Wechsler‐Bellevue for IQ; [<reflink idref="bib32" id="ref21">32</reflink>]) and aggressive behaviours, which had not changed with previous FGAs treatments. All of them had a Clinical Global Impression‐Severity (CGI‐S) score of 5 (markedly ill).</p> <p>At the beginning of the study, all patients were receiving a FGAs and after a period of 24 weeks, 31 (50%) were randomised to olanzapine and 31 (50%) to risperidone.</p> <p>Baseline characteristics (age, gender, level of ID and number of years of previous therapy) were collected at the beginning of the study (see Table 1).</p> <p>1 Baseline characteristics of the sample</p> <p> <ephtml> <table><thead valign="bottom"><tr><th><bold>Characteristics</bold></th></tr></thead><tbody valign="top"><tr><td>Age (years)</td><td /></tr><tr><td> Mean</td><td>48</td></tr><tr><td> SD</td><td>12.45</td></tr><tr><td>Gender, <italic>n</italic> (%)</td><td /></tr><tr><td> Male</td><td>45 (72.6)</td></tr><tr><td> Female</td><td>17 (27.4)</td></tr><tr><td>Level of intellectual disability, <italic>n</italic> (%)</td><td /></tr><tr><td> Mild</td><td>0 (0)</td></tr><tr><td> Moderate</td><td>0 (0)</td></tr><tr><td> Severe</td><td>62 (100)</td></tr><tr><td>Previous years of therapy, <italic>n</italic> (%)</td><td /></tr><tr><td> <5</td><td>5 (8)</td></tr><tr><td> 5–20</td><td>20 (32.3)</td></tr><tr><td> >20</td><td>37 (59.7)</td></tr></tbody></table> </ephtml> </p> <p>Before the observational period on FGAs, all subjects were not receiving any antipsychotic or mood stabiliser.</p> <hd id="AN0057367125-8">Procedure</hd> <p>For all cases medication was started after previous non‐pharmacological interventions had failed. Every subject underwent to a psychiatric diagnostic assessment through the application of the DSM‐IV TR criteria. DSM‐IV TR diagnoses were conducted by an experienced psychiatrist, who had a good knowledge of the basic behaviour and functioning level of each participant. For all participants a formal written consent was compiled. For those who were unable to do it by themselves, it was given by their guardians. The ethics committee agreed to the study. Participants were evaluated during a period of 1 year: 24 weeks before the switch (patients treated with FGAs) and 24 weeks after the switch (patients treated with NGAs: olanzapine or risperidone). The cross‐tapering switch from FGAs to NGAs was conducted by a specialist on 2 weeks (T0–T2), achieving the dosages of 20 mg for olanzapine and 6 mg for risperidone. The switch procedure was gradual as indicated by the literature ([<reflink idref="bib8" id="ref22">8</reflink>]). At T0, subjects received the entire dose of FGA and 5 mg of olanzapine or 2 mg of risperidone. At T1, they received half dose of FGA and 10 mg of olanzapine or 4 mg of risperidone.</p> <hd id="AN0057367125-9">Assessments</hd> <p>Aggressive behaviours were assessed by the Overt Aggression Scale (OAS; [<reflink idref="bib34" id="ref23">34</reflink>]). The OAS is a standardised behavioural checklist, which rates episodes of aggression in four main categories representing escalating violent behaviour: verbal aggression, physical aggression against objects, physical aggression against self and physical aggression against others. Each category consists of four factors ranging in severity from least to most severe.</p> <p>Clinical outcome was measured by the improvement subscale of the CGI 1976. The CGI is a 3‐item observer‐rated scale that measures illness severity (CGI‐S), global improvement or change (CGI‐C) and therapeutic response. The CGI‐S is rated on a 7‐point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI‐C scores range from 1 (very much improved) through to 7 (very much worse). Treatment response ratings should take account of both therapeutic efficacy and treatment‐related adverse events and range from 0 (marked improvement and no side effects) and 4 (unchanged or worse and side effects outweigh the therapeutic effects).</p> <p>Clinical neuroleptic‐induced Parkinsonism symptoms were assessed by Simpson Angus Scale (SAS 1970).</p> <p>Neuroleptic‐induced akathisia and tardive dyskinesia were rated by Abnormal Involuntary Movement Scale (AIMS 1976) and Tardive Dyskinesia Rating Scale (TDRS 1979).</p> <p>Side effects were assessed with Dosage Record and Treatment Emergent Symptoms Scale (DOTES 1976).</p> <p>Clinical laboratory tests including fasting glucose, prolactin, serum creatinine (to value renal function), alanine aminotransaminase (ALT/SGPT), aspartate transaminase (AST/SGOT), gamma‐glutamyl transferase (GGT) (to value hepatic function), HDL cholesterol, direct LDL cholesterol and triglycerides (to value lipid profile) and weight measure were performed at baseline and at the end of the study.</p> <p>The presence of cardiac abnormalities was assessed by 12‐lead electrocardiogram (ECG) at baseline and each 3 weeks throughout the study period.</p> <p>The different effectiveness of olanzapine and risperidone was evaluated by comparing different efficacy on aggressive behaviours (OAS and CGI), safety (DOTES) and persistence on treatment (interruption before the end of study).</p> <hd id="AN0057367125-10">Statistical analysis</hd> <p>Data were analysed with spss version 12.0 for Windows. Statistical tests for comparison between the two groups on their characteristics included 2‐sample <emph>t</emph>‐tests for continuous variables and chi‐square test for categorical variables. Multivariate analyses of continuous outcomes were by regression, with adjustment for baseline value of the response variable. Repeated‐measures analysis of covariance (ANOVA) was used to examine the OAS scores ante and post switch to the two treatment groups (olanzapine and risperidone).</p> <hd id="AN0057367125-11">Results</hd> <p>Cumulative numbers of episodes of verbal aggression (collected by OAS during the first period before the switch) were different into the two groups: 258 (mean = 8.32 ± 6.45) episodes for olanzapine and 198 (mean = 6.39 ± 4.46) for risperidone. OAS scores 24 weeks after the switch showed a decrease of verbal aggression episodes: 57 (mean = 1.84 ± 2.10) episodes for olanzapine and 55 (mean = 1.77 ± 1.91) for risperidone. The incidence of verbal aggression episodes in the treatment group with olanzapine was greater than the treatment group with risperidone (<emph>P</emph> = 0.0029), suggesting for olanzapine more efficacy on reducing verbal aggression episodes. However, both olanzapine and risperidone had shown statistically significant reduction on episodes of verbal aggression (<emph>P</emph> < 0.0001).</p> <p>Cumulative numbers of episodes of aggression against objects (collected by OAS during the first period before the switch) were similar into the two groups: 132 (mean = 4.26 ± 3.90) for olanzapine and 129 (mean = 4.16 ± 3.93) for risperidone. The decrease observed during the second period of the study showed similar efficacy for the two treatment groups. OAS scores 24 weeks after the switch showed a significant decrease of episodes: 40 (mean = 1.29 ± 1.32) for olanzapine and 35 (mean = 1.13 ± 1.23) for risperidone. Both olanzapine and risperidone had shown statistically significant reduction on episodes of aggression against objects (<emph>P</emph> < 0.0001).</p> <p>Cumulative numbers of episodes of physical aggression against self (collected by OAS during the first period before the switch) were quite similar into the two groups: 227 (mean = 7.32 ± 4.28) for olanzapine and 193 (mean = 6.23 ± 4.97) for risperidone. OAS scores 24 weeks after the switch showed a decrease of this type of aggression: the number of episodes was 54 (mean = 1.74 ± 1.32) for olanzapine and 57 (mean = 1.84 ± 1.83) for risperidone. Both olanzapine and risperidone had shown statistically significant reduction on episodes of physical aggression against self (<emph>P</emph> < 0.0001).</p> <p>Cumulative numbers of episodes of physical aggression against others (collected by OAS during the first period before the switch) were quite similar into the two groups: 89 (mean = 2.87 ± 3.72) for olanzapine and 63 (mean = 2.03 ± 2.33) for risperidone. OAS scores 24 weeks after the switch showed a significant decrease of episodes: 37 (mean = 1.19 ± 1.14) for olanzapine and 22 (mean = 0.71 ± 0.90) for risperidone. Both olanzapine and risperidone had shown statistically significant reduction on episodes of physical aggression against others (<emph>P</emph> < 0.0001).</p> <p>In all cases the episodes of aggression were controlled for age, gender and previous years of therapy. No differences between the two groups were found.</p> <p>Cumulative number of aggressive episodes throughout the study is shown in Fig. 1.</p> <p>Graph: 1 Cumulative number of aggressive episodes by time.</p> <p>Outcome, as measured by the CGI‐C scale, was rated as 'very much improved' in nine patients treated with olanzapine and 19 patients treated with risperidone, as 'much improved' in 12 patients treated with olanzapine and 10 patients treated with risperidone and as 'minimally improved' in 10 patients treated with olanzapine and two patients treated with risperidone (see Table 2). The efficacy index showed that the therapeutic effect was rated as moderate for seven patients treated with olanzapine and five patients treated with risperidone (decided improvement with partial remission of symptoms, but presence of sedation's side effect that significantly interferes with patient's functioning), as moderate for two patients treated with risperidone (decided improvement with partial remission of symptoms, but presence of extrapyramidal side effects (EPSEs) that significantly interferes with patient's functioning), as minimal for 10 patients treated with olanzapine and two patients treated with risperidone (slight improvement which does not alter status of care of patient and presence of side effects that do not significantly interfere with patient's functioning) and as moderate for all others patients (decided improvement with partial remission of symptoms and presence of side effects that do not significantly interfere with patient's functioning). These results are summarised in Table 3.</p> <p>2 Clinical global impression (CGI) improvement by treatment</p> <p> <ephtml> <table><thead valign="bottom"><tr><th><bold>CGI improvement</bold></th><th><bold>Olanzapine</bold></th><th><bold>Risperidone</bold></th></tr><tr><th><bold><italic>n</italic> (%)</bold></th><th><bold><italic>n</italic> (%)</bold></th></tr></thead><tbody valign="top"><tr><td>Very much improved</td><td>9 (29)</td><td>19 (61.3)</td></tr><tr><td>Much improved</td><td>12 (38.8)</td><td>10 (32.2)</td></tr><tr><td>Minimally improved</td><td>10 (32.2)</td><td>2 (6.5)</td></tr><tr><td>Total</td><td>31 (100)</td><td>31 (100)</td></tr></tbody></table> </ephtml> </p> <p>3 Efficacy index by treatment</p> <p> <ephtml> <table><thead valign="bottom"><tr><th><bold>Efficacy index</bold></th><th><bold>Olanzapine</bold></th><th><bold>Risperidone</bold></th></tr><tr><th><bold><italic>n</italic> (%)</bold></th><th><bold><italic>n</italic> (%)</bold></th></tr></thead><tbody valign="top"><tr><td>Moderate therapeutic effect</td><td>14 (45.2)</td><td>22 (71)</td></tr><tr><td> Decided improvement with partial remission of symptoms and presence of side effects that do not significantly interfere with patient's functioning</td><td /><td /></tr><tr><td>Moderate therapeutic effect</td><td>7 (22.6)</td><td>5 (16.1)</td></tr><tr><td> Decided improvement with partial remission of symptoms, but presence of sedation's side effect that significantly interferes with patient' functioning</td><td /><td /></tr><tr><td>Moderate therapeutic effect</td><td>–</td><td>2 (6.5)</td></tr><tr><td> Decided improvement with partial remission of symptoms, but presence of extrapiramidal side effects (EPSEs) that significantly interferes with patient' functioning</td><td /><td /></tr><tr><td>Minimal therapeutic effect</td><td>10 (32.2)</td><td>2 (6.5)</td></tr><tr><td> Slight improvement which does not alter status of care of patient and presence of side effects that do not significantly interfere with patient's functioning</td><td /><td /></tr><tr><td>Total</td><td>31 (100)</td><td>31 (100)</td></tr></tbody></table> </ephtml> </p> <p>Neurological side effect experienced by participants during the trial was sedation, more present in the olanzapine group (<emph>n</emph> = 7, 11.3%) respect to risperidone group (<emph>n</emph> = 5, 8.1%). EPSEs were shown only in two patients treated with risperidone (<emph>n</emph> = 2, 3.2%).</p> <p>Abnormalities at the ECG were showed only in the risperidone group (<emph>n</emph> = 2, 3.2%).</p> <p>Weight measure, fasting glucose value, lipid profile, renal function and hepatic function were similar into the two treatment groups, whereas the presence of high prolactin's value (<emph>n</emph> = 22, 35.5% vs. <emph>n</emph> = 30, 48.4%; <emph>P</emph> = 0.005) showed statistically significant differences between olanzapine and risperidone group.</p> <p>Side effects are summarised in Table 4.</p> <p>4 Type and number of side effects by treatment</p> <p> <ephtml> <table><thead valign="bottom"><tr><th><bold>Side effects</bold></th><th><bold>Olanzapine (20 mg/day)</bold></th><th><bold>Risperidone (6 mg/day)</bold></th><th><bold>Total</bold></th></tr><tr><th><bold><italic>n</italic> (%)</bold></th><th><bold><italic>n</italic> (%)</bold></th><th><bold><italic>n</italic> (%)</bold></th></tr></thead><tbody valign="top"><tr><td>Sedation</td><td>7 (22.6)</td><td>5 (16.1)</td><td>12 (19.4)</td></tr><tr><td>Weight gain</td><td>7 (22.6)</td><td>3 (9.7)</td><td>10 (16.1)</td></tr><tr><td> No change</td><td>18 (58.1)</td><td>22 (71)</td><td>40 (64.6)</td></tr><tr><td> Reduction</td><td>6 (19.3)</td><td>6 (19.3)</td><td>12 (19.3)</td></tr><tr><td>Extrapyramidal side effect (EPSEs)</td><td>–</td><td>2 (6.4)</td><td>2 (3.2)</td></tr><tr><td>Hyperprolactinemia</td><td>22 (71)</td><td>30 (83.9)</td><td>52 (83.9)</td></tr><tr><td>Abnormalities laboratory test of hepatic function</td><td>4 (12.9)</td><td>6 (19.3)</td><td>10 (16.1)</td></tr><tr><td>Abnormalities lipid profile</td><td>5 (16.1)</td><td>5 (16.1)</td><td>10 (16.1)</td></tr><tr><td>Hyperglicemia</td><td>1 (3.2)</td><td>–</td><td>1 (1.6)</td></tr><tr><td>Electrocardiogram abnormalities</td><td>–</td><td>2 (6.4)</td><td>2 (3.2)</td></tr></tbody></table> </ephtml> </p> <hd id="AN0057367125-12">Discussion</hd> <p>Aggressiveness is a very frequent reported BP for persons with ID ([<reflink idref="bib5" id="ref24">5</reflink>]) and the most common cause for psychiatric admission ([<reflink idref="bib22" id="ref25">22</reflink>]).</p> <p>Antipsychotics are among the most widely used psychotropic drugs in PWID ([<reflink idref="bib17" id="ref26">17</reflink>]; [<reflink idref="bib24" id="ref27">24</reflink>]). There are two main reasons for the use of these drugs in this population. Firstly, APs are used specifically to treat concurrent psychiatric disorders (e.g. psychosis and affective disorders). Secondly, and perhaps more controversially, APs are used in a more non‐specific way to control aberrant or challenging behaviours, including aggression and self‐injury ([<reflink idref="bib4" id="ref28">4</reflink>]).</p> <p>It has been shown that APs can be efficacious in the treatment of aggressive behaviour in PWID ([<reflink idref="bib25" id="ref29">25</reflink>]; [<reflink idref="bib18" id="ref30">18</reflink>]; [<reflink idref="bib13" id="ref31">13</reflink>]; [<reflink idref="bib11" id="ref32">11</reflink>]).</p> <p>Among the typical ones the most frequently studied and prescribed are haloperidol, thioridazine and chlorpromazine ([<reflink idref="bib18" id="ref33">18</reflink>]).</p> <p>Even though their efficacy, a few studies about the safety of antipsychotic medications in PWID, show the onset of even severe side effects (tardive dyskinesia, neuroleptic malignant syndrome, sedation, dystonia and extrapyramidal signs) related to the use of traditional APs. This is the reason why the use of these compounds should be very rarely considered and limited to specific conditions ([<reflink idref="bib1" id="ref34">1</reflink>]) at precise dosage.</p> <p>More recently, the newer atypical APs have been introduced into clinical practice.</p> <p>Atypicals appear better tolerated than the older ([<reflink idref="bib10" id="ref35">10</reflink>]). In fact, new APs show a high safety level; side effects most frequently reported result to be weight gain followed by sedation and more rarely extrapyramidal signs and among the most severe agranulocytosis (for Clozapine) ([<reflink idref="bib1" id="ref36">1</reflink>]).</p> <p>Considering the NGAs, risperidone is the molecule most often studied. In studies concerning the control of anger and aggressiveness, risperidone proved to be more effective than traditional APs with low incidence of extrapyramidal symptoms. For these reasons it is considered the first‐choice drug for such disorders ([<reflink idref="bib18" id="ref37">18</reflink>]).</p> <p>Olanzapine too shows more effectiveness than traditional ones in patients with ID.</p> <p>[<reflink idref="bib16" id="ref38">16</reflink>]) found that the addition of olanzapine in intellectually disabled adults who were receiving conventional antipsychotic drugs was associated with a decrease in aggressive, self‐injurious and disruptive behaviours and it allowed to decrease the dosage of typical APs or the cessation of their administration. So, also olanzapine seems to have some positive effects in reducing challenging behaviours (self‐injurious behaviour and aggressiveness) showing general well tolerability ([<reflink idref="bib18" id="ref39">18</reflink>]).</p> <p>As far as regards clozapine, the second more studied atypical, there are some evidences of good clinical efficacy, especially in patients who did not respond to other medications ([<reflink idref="bib18" id="ref40">18</reflink>]).</p> <p>Only a few studies compare head to head the clinical effectiveness of these different drugs.</p> <p>Two of these are open prospective naturalistic studies that compare risperidone with olanzapine ([<reflink idref="bib33" id="ref41">33</reflink>]; [<reflink idref="bib6" id="ref42">6</reflink>]). All patients attending a specialist mental health service for people with ID and commenced on either risperidone or olanzapine within a period of one or two years were included in these studies. In both of them it comes out that olanzapine tends to be prescribed mostly for psychotic disorders and shows good rates of response, whereas risperidone is prescribed mostly for people with behavioural disturbance associated with a psychiatric diagnosis and it also has a good effectiveness.</p> <p>The main limitation of these studies is the method of valuation used to measure clinical outcome which was in both of them the CGI scale, which can value aggressive bahaviour in an indirect way.</p> <p>In our study the evaluation head to head of clinical effectiveness of risperidone and olanzapine was made with the OAS, which is a standardised behavioural checklist that allow to rate episodes of aggression in four main categories representing escalating violent behaviour.</p> <p>Both risperidone and olanzapine appeared to be more effective than FGAs in reduction of aggressive behaviours (see Fig. 2), but when compared for cumulative number of aggressive episodes from T‐24 to T0, patients on olanzapine resulted to be more aggressive than patients on risperidone. This suggests that olanzapine was associated with a major decreased incidence of verbal aggressive behaviour and physical aggression against self, and to a lesser extent with a decrease incidence of aggression against objects and physical aggression against others, than risperidone. The combined dopamine D2 and serotonin 5HT2 receptor blockade (different from risperidone receptors profile and more similar to clozapine), could explain minor differences of incisiveness on reducing aggressivity ([<reflink idref="bib23" id="ref43">23</reflink>]; [<reflink idref="bib28" id="ref44">28</reflink>]; [<reflink idref="bib29" id="ref45">29</reflink>]).</p> <p>Graph: 2 Variation of number of aggressive episodes between first generation antipsychotic and new generation antipsychotic phases.</p> <p>The degree of improvement in our sample was very high, not only for OAS scores, but also scores on CGI scale. Clinical outcome using the CGI scale suggested that both atypical APs have demonstrated a considerable degree of effectiveness against the aggressive behaviours. Nevertheless, risperidone appeared to be more effective than olanzapine on CGI improvement and on efficacy index.</p> <p>Both drugs were well tolerated, with only two neurological side effects reported by patients (the group treated with olanzapine reported more sedation than risperidone group, but the difference was not statistically significant and only two patients treated with risperidone reported EPSEs). We have found ECG abnormalities only in the risperidone group and statistically significant differences on prolactin value. Hyperprolactinemia was significantly more frequent in patients treated with risperidone compared with patients treated with olanzapine (<emph>P</emph> = 0.005).</p> <p>In conclusion, our findings suggest that in PWID olanzapine and risperidone can be effective against aggressive behaviours and well tolerated, with side effects similar to those encountered in other patient populations.</p> <p>Although NGAs have repeatedly shown greater efficacy and safety than FGAs, there is still a need for controlled trial and more methodically researches to confirm their benefit on PWID. The confirmation by further research of at least equivalent efficacy of NGAs in comparison to FGAs on BPs in PWID, could have important repercussion on daily practice in consideration of the different impact that the two pharmacologic classes have on new person‐centred outcome measures, such as Quality of Life.</p> <ref id="AN0057367125-13"> <title> References </title> <blist> <bibl id="bib1" idref="ref34" type="bt">1</bibl> <bibtext> Advokat C. D., Mayville E. A. & Matson J. L. (2000) Side effect profiles of atypical antipsychotics, typical antipsychotics, or no psychotropic medications in persons with mental retardation. Research in Developmental Disabilities 21, 75 – 84.</bibtext> </blist> <blist> <bibl id="bib2" idref="ref7" type="bt">2</bibl> <bibtext> Aman M. G., De Smedt G., Derivan A., Lyons B., Findling R. 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(2008) Risperidone, haloperidol, and placebo in the treatment of aggressive challenging behaviour in patients with intellectual disability: a randomised controlled trial. The Lancet 371, 57 – 63.</bibtext> </blist> <blist> <bibtext> Wechsler D. (1944) The Measurement of Adult Intelligence. Williams and Wilkins, Baltimore, MD.</bibtext> </blist> <blist> <bibtext> Williams H., Clarke R., Bouras N. Martin J. & Holt G. (2000) Use of the atypical antipsychotics olanzapine and risperidone in adults with intellectual disability. Journal of Intellectual Disability Research 44, 164 – 9.</bibtext> </blist> <blist> <bibtext> Yudofsky S. C., Silver J. M., Jackson W., Endicott J. & Williams D. (1986) The Overt Aggression Scale for the objective rating of verbal and physical aggression. American Journal of Psychiatry 143, 35 – 9.</bibtext> </blist> <blist> <bibtext> Zarcone J. R., Hellings J. A., Crandall K., Reese R. M., Marquis J., Fleming K. et al. (2001) Effects of risperidone on aberrant behavior of persons with developmental disabilities: 1. A double‐blind crossover study using multiple measures. American Journal on Mental Retardation 106, 525 – 38.</bibtext> </blist> </ref> <aug> <p>By M. Amore; M. Bertelli; D. Villani; S. Tamborini and M. 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  Data: Olanzapine vs. Risperidone in Treating Aggressive Behaviours in Adults with Intellectual Disability: A Single Blind Study
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  Data: <searchLink fieldCode="AR" term="%22Amore%2C+M%2E%22">Amore, M.</searchLink><br /><searchLink fieldCode="AR" term="%22Bertelli%2C+M%2E%22">Bertelli, M.</searchLink><br /><searchLink fieldCode="AR" term="%22Villani%2C+D%2E%22">Villani, D.</searchLink><br /><searchLink fieldCode="AR" term="%22Tamborini%2C+S%2E%22">Tamborini, S.</searchLink><br /><searchLink fieldCode="AR" term="%22Rossi%2C+M%2E%22">Rossi, M.</searchLink>
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  Data: <searchLink fieldCode="SO" term="%22Journal+of+Intellectual+Disability+Research%22"><i>Journal of Intellectual Disability Research</i></searchLink>. Feb 2011 55(2):210-218.
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  Data: Wiley-Blackwell. 350 Main Street, Malden, MA 02148. Tel: 800-835-6770; Tel: 781-388-8598; Fax: 781-388-8232; e-mail: cs-journals@wiley.com; Web site: http://www.wiley.com/WileyCDA/
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  Data: Journal Articles<br />Reports - Research
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  Data: <searchLink fieldCode="DE" term="%22Mental+Retardation%22">Mental Retardation</searchLink><br /><searchLink fieldCode="DE" term="%22Measures+%28Individuals%29%22">Measures (Individuals)</searchLink><br /><searchLink fieldCode="DE" term="%22Program+Effectiveness%22">Program Effectiveness</searchLink><br /><searchLink fieldCode="DE" term="%22Statistical+Analysis%22">Statistical Analysis</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+Therapy%22">Drug Therapy</searchLink><br /><searchLink fieldCode="DE" term="%22Aggression%22">Aggression</searchLink><br /><searchLink fieldCode="DE" term="%22Behavior+Modification%22">Behavior Modification</searchLink><br /><searchLink fieldCode="DE" term="%22Adults%22">Adults</searchLink><br /><searchLink fieldCode="DE" term="%22Symptoms+%28Individual+Disorders%29%22">Symptoms (Individual Disorders)</searchLink><br /><searchLink fieldCode="DE" term="%22Outcomes+of+Treatment%22">Outcomes of Treatment</searchLink>
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  Label: DOI
  Group: ID
  Data: 10.1111/j.1365-2788.2010.01352.x
– Name: ISSN
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  Group: ISSN
  Data: 0964-2633
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Background: Aggressive behaviour represents a frequent symptom in people with intellectual disability (PWID). Despite uncertain evidence of effectiveness, the use of antipsychotics (APs) drugs to treat aggressive behaviour is very common. Antipsychotic medication of aggressivity in PWID has recently become one of the most debated issues in mental health and the need of further research is persistently stressed by most researchers. Aim: The present study was firstly aimed at evaluating the effectiveness (efficacy on target behaviour, safety and persistence on treatment) of new generation APs, in particular, olanzapine and risperidone in treating aggressive behaviour in PWID for who previous medication with first generation APs (FGAs) were not effective. Methods: 62 subjects with intellectual disability underwent to a 2-arm, parallel group pragmatic trial of olanzapine and risperidone with balanced randomisation and blind assessment of outcome at 4, 8, 12, 16, 20 and 24 weeks after a switch (cross-tapering) from a 24-week treatment with FGAs. Aggressive behaviours were assessed by Overt Aggression Scale (OAS) and clinical outcome by Clinical Global Impression Scale. Side effects were assessed with Dosage Record and Treatment Emergent Symptoms Scale, other symptom-specific scales, laboratory and instrumental tests. Results: Both risperidone and olanzapine resulted to be more effective than FGAs in reducing aggressive behaviour. Repeated-measures analysis of covariance revealed that treatment groups differed for cumulative number of aggressive episodes during the FGAs treatment, which was higher for olanzapine. Conclusion: Our findings seem to confirm that olanzapine and risperidone can be effective in reducing aggressive behaviour in PWID. Both compounds resulted to be well tolerated, with side effects similar to those encountered in other patient populations.
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  Data: 2011
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  Data: EJ927747
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        Value: 10.1111/j.1365-2788.2010.01352.x
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      – Text: English
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      Pagination:
        PageCount: 9
        StartPage: 210
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      – SubjectFull: Mental Retardation
        Type: general
      – SubjectFull: Measures (Individuals)
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      – SubjectFull: Outcomes of Treatment
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      – TitleFull: Olanzapine vs. Risperidone in Treating Aggressive Behaviours in Adults with Intellectual Disability: A Single Blind Study
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