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Page 1: Symptom control, functioning, and hospitalization status in French patients changed from oral atypical antipsychotics to risperidone long-acting injectable

ORIGINAL ARTICLE

Symptom control, functioning, and hospitalization status in Frenchpatients changed from oral atypical antipsychotics to risperidonelong-acting injectable

PIERRE-MICHEL LLORCA1, JEAN-PIERRE KAHN2, VERONIQUE MOREAU-MALLET3,

PHILIPPE BOUHOURS3 & the French StoRMi investigators group

1Service Hospitalier Universitaire, Psychiatrie B, Clermont-Ferrand, France, 2Service de Psychiatrie et Psychologie Clinique,

Centre Hospitalier Universitaire de Nancy, Hopital Jeanne d’Arc, Toul, France, and 3Janssen-Cilag SA, Issy-les-Moulineaux,

France

AbstractObjective. To investigate efficacy and tolerability of risperidone long-acting injectable (RLAI) in French patients withschizophrenia or other psychotic disorders, who were all switching from previous treatment with oral atypical antipsychotics.The impact of treatment with RLAI on the hospitalization status of these patients was also examined. Methods. Clinicallystable patients requiring a treatment change received 25 mg RLAI (increased to 37.5 or 50 mg if required) every 2 weeks for6 months. Results. Of 130 patients (68.5% male, mean age 36.2 years), most (83.8%) had DSM-IV schizophrenia (mainlyparanoid). Previous treatments were risperidone (80.8%), olanzapine (10.0%) and amisulpride (10.0%). Out of 66 patientshospitalized at baseline, 51 were outpatients at endpoint. Mean total PANSS, CGI-S and GAF scores were significantlyreduced from baseline to treatment endpoint (p B/0.001). Of those patients reported as moderate to severely ill at thebeginning of the trial (81.3%), fewer had the same classification at endpoint (50.8%). Mean scores for total ESRS andParkinsonism subscales were significantly reduced after only 1 month of treatment (p B/0.001). Conclusion. Treatment withRLAI significantly improved disease symptoms, functioning, hospitalization status, and reduced movement disorders, inpsychotic patients considered clinically stable on oral atypical antipsychotics.

Key Words: Schizophrenia, atypical antipsychotic, long-acting risperidone, tolerability, functioning, hospitalization

Introduction

Schizophrenia is a severe mental illness which is

ranked by the World Health Organization as the

eighth leading cause of long-term disability world-

wide [1]. Strategies for the optimal management of

patients with schizophrenia (and other psychotic

disorders) address not only the symptoms of the

illness, but are increasingly focussed on improving

functioning and quality of life, achieving remission,

and preventing relapse [2,3]. The atypical antipsy-

chotics are known to substantially improve the

positive, negative, affective, and cognitive symptoms

of schizophrenia [3,4]. Furthermore, they may also

be more effective than conventional neuroleptics in

improving quality of life and patient satisfaction with

treatment [5,6], and preventing relapse [7�9].

Prevention of relapse in patients with schizophre-

nia depends in particular on compliance with treat-

ment, and covert non-compliance is a major risk

factor for relapse and therefore rehospitalization

[8,10�12]. Other factors affecting relapse involve

demographics (age and gender) [12], severe residual

psychopathology [8], comorbid alcohol abuse

[11,12], and poor social relationships with family

and care providers [8]. The first episode of psychotic

illness has been identified as a key intervention point

for prevention of relapse [13]. Preliminary results

suggest that treatment with low doses of the oral

atypical antipsychotic risperidone could slow pro-

gression of schizophrenia and reduce relapse rates,

when given at an early stage of psychosis [13�15].

Nevertheless, the use of oral atypical antipsychotics

has not substantially improved the limited compli-

ance typically seen among patients on oral therapy

[16�20].

Injectable depot preparations of conventional

neuroleptics have played a traditional role in mana-

ging patients with schizophrenia. These injectable

preparations ensure delivery of medication, and

Correspondence: Dr. med. Philippe Bouhours, Janssen-Cilag S.A., 1 rue Camille Desmoulins, TSA 91003, 92787 Issy-les-Moulineaux Cedex 9, France. Tel:

�/33 1 5500 4053. E-mail: [email protected]

International Journal of Psychiatry in Clinical Practice, 2006; 10(4): 276�284

(Received 29 November 2005; accepted 6 March 2006)

ISSN 1365-1501 print/ISSN 1471-1788 online # 2006 Taylor & Francis

DOI: 10.1080/13651500600736767

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Page 2: Symptom control, functioning, and hospitalization status in French patients changed from oral atypical antipsychotics to risperidone long-acting injectable

enable the attending physician to monitor the patient

for compliance with treatment. This is an important

first step in preventing relapse. Depot preparations

also reduce the daily fluctuations in drug plasma

concentrations associated with oral preparations.

This maximizes efficacy and tolerability of treatment

[21,22], along with patient satisfaction with their

medication [23]. Indeed, patients receiving depot

preparations are known to have lower rehospitaliza-

tion and relapse rates than those on oral medication

alone [2,24,25]. Compared with the atypical anti-

psychotics, conventional depot neuroleptics have a

lower efficacy with respect to negative symptoms,

generate more movement disorders [18], and induce

adverse events including pain at the injection site

[26,27]. The development of risperidone long-acting

injectable (RLAI) combines the advantages of an

injectable preparation with the clinical benefit of an

atypical antipsychotic [22,28].

Clinical studies have shown RLAI to be effective

for the short-term [29] and long-term [30] treat-

ment of patients with schizophrenia. Improvements

were observed in psychopathology [29,30], in

health-related quality of life [31,32], in symptom

remission [33], and in frequency and duration of

hospitalization [34,35]. This is particularly impor-

tant since hospitalization is a major cost driver in the

treatment of patients with schizophrenia [36]. A

reduction in severity of movement disorders was also

observed among patients on RLAI medication

[37,38].

The Switch to Risperidone Microspheres

(StoRMi) trial investigated the efficacy and safety

of switching patients with schizophrenia or related

psychotic disorders (and who required a change in

their medication) to RLAI, without first administer-

ing an oral risperidone run-in [32]. This paper

reports the findings from a subgroup of French

patients who were changed directly to RLAI from

oral atypical antipsychotics (mainly oral risperi-

done). Some emphasis was placed on investigating

the effect of treatment with RLAI on hospitalization

rate among these patients.

Patients and methods

This analysis formed part of a non-randomized,

single-arm, multicentre European trial of 6 months

duration. Objectives were to evaluate the efficacy,

tolerability and safety of transferring patients with

schizophrenia or other psychotic disorders to RLAI

medication without an oral risperidone run-in. The

trial was conducted in accordance with the

ICH-Good Clinical Practice Guidelines, the De-

claration of Helsinki, and the local laws and

regulations. The study protocol was reviewed and

approved by the appropriate Independent Ethics

Committees.

Patients

Patients enrolled in the trial had a psychiatric history

of schizophrenia or other psychotic disorders defined

by the Diagnostic and Statistical Manual of Mental

Disorders, 4th edition (DSM-IV) [39], and were

considered to require a change in their current

medication by the attending physician.

All patients were at least 18 years old and they (or

their legal representatives) provided written in-

formed consent prior to enrollment. Patients were

required to be symptomatically stable, and on a fixed

dose of one or more antipsychotic drugs for at least 1

month before the screening visit. They could either

be hospitalized or outpatients at the time of enroll-

ment and during the trial.

Patients were excluded from the trial if they were

known to be intolerant or non-responsive to risper-

idone, had received treatment with clozapine during

the previous 3 months, or had participated in

another investigational drug trial within 30 days

prior to enrollment. Those with a serious unstable

medical condition including clinically relevant la-

boratory abnormalities, a history or current symp-

toms of tardive dyskinesia and neuroleptic malignant

syndrome were also excluded from the trial. Preg-

nant or breast-feeding women were excluded, whilst

others of childbearing ability were required to use

adequate contraception and show a negative urine

pregnancy test at the screening visit.

Medication

Risperidone long-acting injectable (RLAI) was given

by intramuscular (gluteal) injection every 2 weeks.

The recommended starting dose was 25 mg, but

patients suffering from persistent symptoms or

known only to respond to higher doses of antipsy-

chotics could be started with doses of either 37.5 or

50 mg. Thereafter, the dosage of RLAI was adjusted

to suit the individual patient’s symptoms and re-

sponse to treatment.

Since RLAI was administered without an oral

risperidone run-in, it was recommended that toler-

ability to risperidone was established in those

patients with no previous history of risperidone

use. These patients received 2�/1 mg oral risper-

idone once daily for 2 days prior to treatment with

RLAI. Patients treated previously with an oral

antipsychotic continued to receive that drug at the

same dose for 21 days following the first injection

with RLAI, after which it was stopped or tapered off

within 3 days. Patients treated previously with

conventional depot neuroleptics were changed to

RLAI according to a procedure described previously

[32].

Patients were allowed to continue receiving other

psychotropic medications prescribed prior to the

trial (e.g., for sleep induction or sedation), provided

the dose remained stable. Oral risperidone supple-

Direct change to risperidone long-acting injectable 277

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Page 3: Symptom control, functioning, and hospitalization status in French patients changed from oral atypical antipsychotics to risperidone long-acting injectable

mentation was used to manage any exacerbation of

psychotic symptoms between study visits which

required an immediate dose adjustment, and also

for up to 3 weeks after an increase in the dose of

RLAI if an immediate clinical effect was needed.

Patients could also receive benzodiazepines as rescue

medication for periods not exceeding ten consecu-

tive days during the trial.

Assessments

Treatment efficacy was assessed at baseline and

thereafter at 1, 3 and 6 months (trial endpoint)

using the Positive and Negative Syndrome Scale

(PANSS). The primary efficacy criterion was the

mean change from baseline in PANSS total score at

endpoint. Secondary efficacy assessments were

made using the following rating scales during the

6-month trial period. Clinical Global Impression-

Disease Severity (CGI-S) evaluated disease severity

at baseline and thereafter at 1, 3 and 6 months. The

CGI-S categorized patients according to whether

they were ‘‘severely ill’’, ‘‘markedly ill’’, ‘‘moderately

ill’’, ‘‘mildly ill’’, ‘‘borderline ill’’, or ‘‘normal’’.

Global Assessment of Functioning (GAF) evaluated

the functional status of patients at baseline and at

endpoint on a scale where 100 represented the best

functioning outcome. The MOS 36-Item Short-

Form Health Survey (SF-36) evaluated the health-

related quality of life of patients at baseline, after

3 months and at endpoint. Patient satisfaction with

treatment was rated at baseline and at endpoint

according to whether it was considered ‘‘very

good’’, ‘‘good’’, ‘‘moderate’’, ‘‘poor’’ or ‘‘very

poor’’.

The severity of movement disorders was evaluated

at baseline and thereafter at 1, 3 and 6 months using

the Extrapyramidal Symptoms Rating Scale (ESRS).

Adverse events, vital signs and body weight were

recorded during the same study visits.

Statistical analyses

Safety analyses were performed using data from the

intention-to-treat (ITT) population, which com-

prised all patients receiving at least one dose of

RLAI. Efficacy analyses were performed using data

from patients in the ITT population who had at least

one post-baseline efficacy assessment. Efficacy data

were analysed using the last-observation-carried-

forward (LOCF) method. Data were presented as

mean9/standard deviation unless otherwise stated.

Changes from baseline to endpoint in PANSS

scores, CGI-S, GAF, SF-36, patient satisfaction

with treatment, and ESRS scores were analysed

using the Wilcoxon signed-rank test (two-tailed) at

the 5% significance level.

Results

Patient demographics

The original trial involved 1876 patients. Of the 202

patients recruited in France, 130 were switched from

oral atypical antipsychotics to RLAI. This subgroup

of patients formed the basis for the present analysis.

Baseline demographic and psychiatric characteristics

of this subgroup entering the trial are shown in Table

I. Most patients were diagnosed with schizophrenia

(83.8%), and 61.5% of these suffered from the

paranoid subtype.

Medication

At trial entry, the atypical antipsychotics given were

risperidone (80.8%), olanzapine (10.0%) and ami-

sulpride (10.0%) (Table II). In addition, some

patients received conventional oral neuroleptics

(2.3%), and/or conventional depot neuroleptics

(6.2%). Most patients were on monotherapy

(86.2%) while those on polytherapy (18 patients)

were switched to RLAI from one antipsychotic (3

patients), or more than one antipsychotic (15

patients) drug in their treatment regimens. Patients

were switched to RLAI for various reasons including

non-compliance (64.6%), insufficient efficacy

(18.5%), side effects (mostly movement disorders,

5.4%), and other reasons (18.5%) all associated with

their previous medication.

Table I. Baseline demographic and psychiatric characteristics of

the French subgroup of patients switched from atypical anti-

psychotics to RLAI.

Number of patients 130

Males/females 89 (68.5%)/

41 (31.5%)

Race:

Caucasian 109 (83.8%)

Oriental 8 (6.2%)

Black 7 (5.4%)

Hispanic 2 (1.5%)

Other 4 (3.1%)

Age (year)a 36.29/11.5

Height (cm)a 171.09/9.4

Weight (kg)a 76.19/14.8

Body Mass Index (kg/m2)a 26.19/5.0

Diagnosis (DSM-IV):

Schizophrenia 109 (83.8%)

Schizoaffective disorder 13 (10.0%)

Schizophreniform disorder 3 (2.3%)

Other 5 (3.8%)

Psychiatric history:

Age at onset of symptoms (years)a 23.59/7.3

Age at diagnosis (years)a 26.09/8.1

Ever hospitalized 127 (97.7%)

Hospitalized at baseline 66 (50.8%)

Hospitalized at endpoint 22 (16.9%)

Previous hospitalizationsa 6.99/7.8

aMean9/SD.

278 P.-M. Llorca et al.

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Page 4: Symptom control, functioning, and hospitalization status in French patients changed from oral atypical antipsychotics to risperidone long-acting injectable

The majority of patients received RLAI at an

initial starting dose of 25 mg (80.8%), and those

remaining received dosages of either 37.5 mg

(12.3%) or 50 mg (6.9%). At trial endpoint, the

proportion of patients receiving the 25 mg dosage

was 44.9%, whereas those receiving dosages of 37.5

and 50 mg were 19.7% and 34.6%, respectively.

During the trial, 17.7% of patients received oral

risperidone supplementation at a mean mode dosage

of 3.39/1.4 mg for a mean duration of 32.79/27.1

days.

Compliance and hospitalizations

The trial had a high completion rate (70.0%), with

only 3.1% discontinuing treatment with RLAI due

to non-compliance. Other reasons for discontinuing

treatment with RLAI included withdrawal of consent

(10.0%), insufficient efficacy (6.2%), loss to follow-

up (5.4%), adverse events (2.3%), and others

(3.1%). Out of 66 patients hospitalized at baseline,

51 were outpatients at endpoint. However, seven of

those patients hospitalized at endpoint had not been

hospitalized at baseline.

Treatment efficacy

Efficacy analysis was performed on data available for

128 patients. There was a significant decrease in

mean total PANSS score from 78.39/24.1 (97.5%

confidence interval 73.5�83.2) at baseline to 67.89/

26.6 (97.5% confidence interval 62.5�73.1) at trial

endpoint (p B/0.001). This corresponded with a shift

from baseline score of �/10.59/22.1. A significant

reduction in patient symptoms was apparent after

only 1 month of treatment with RLAI, and improve-

ment continued until the trial endpoint (Figure 1).

At endpoint, 41.4% of patients displayed a ]/20%

improvement in the total PANSS score compared

with baseline. Significant improvements (p 5/0.001)

from baseline to endpoint were also observed in

scores for the PANSS positive (16.59/7.0 vs. 15.09/

8.1), negative (22.79/8.1 vs. 18.89/7.9) and general

psychopathology subscales (39.29/12.5 vs. 34.19/

13.4).

All Marder factors [40] (except for uncontrolled

hostility/excitement factor) improved significantly

(p B/0.001) from baseline to endpoint (Figure 2).

Other assessments showed significant improve-

ments in the CGI-S (p B/0.001). Of those patients

reported as moderate to severely ill at the beginning

of the trial (81.3%), fewer had the same classifica-

tion at endpoint (50.8%) (Figure 3). Patient func-

tioning determined from the mean GAF score was

also significantly improved (p B/0.001) from baseline

(53.29/15.8) to endpoint (59.89/19.9). Further-

more, the percentage of patients rating their satisfac-

tion with treatment as ‘‘very good’’ increased from

baseline (11.6%) to endpoint (29.5%). Health-

related quality of life (SF-36) improved during the

trial, with significant increases from baseline to

endpoint (p B/0.05) in mean scores for all SF-36

factors except vitality (Figure 4). Clinically signifi-

Table II. Survey of antipsychotic drugs used by the French

subgroup of patients before switching to RLAI.

Antipsychotic drug Number of

patientsa

Mean dose

(mg/day)

Conventional oral neuroleptics 3 (2.3%)

Haloperidal 1 90.0

Levomepromazine 2 125.09/35.4

Conventional depot neuroleptics 8 (6.2%)

Flupentixol decanoate 1 1.4

Fluphenazine decanoate 1 37.5

Haloperidol decanoate 3 7.69/5.5

Pipotiazine palmitate 2 8.09/3.8

Zuclopenthixol decanoate 1 14.3

Atypical antipsychotics 130 (100%)

Amisulpride 13 538.59/352.5

Olanzapine 13 19.29/10.0

Risperidone 105 6.49/3.0

aSome patients were switched from more than one drug.

60

65

70

75

80

Mea

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tal P

AN

SS

sco

re

Mean 78.3 71.9 70.2 64.5 67.8

Standard deviation 24.1 26.4 28.4 25.6 26.6

Number of patients 128 126 115 104 128

Baseline Month 1 Month 3 Month 6 Endpoint

Figure 1. Total PANSS scores at each visit and at trial endpoint (p B/0.001 all shifts versus baseline).

Direct change to risperidone long-acting injectable 279

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Page 5: Symptom control, functioning, and hospitalization status in French patients changed from oral atypical antipsychotics to risperidone long-acting injectable

cant improvements (�/5 points) occurred in physical

functioning, role physical, bodily pain, general

health, social functioning, role emotional, and men-

tal health factors.

Drug safety

Mean scores for total ESRS and Parkinsonism

subscales were both significantly reduced after only

1 month of treatment (p B/0.001), and continued to

improve until endpoint (Figure 5). The remainder of

ESRS subscales (except CGI-S for dystonia), were

also significantly improved from baseline to endpoint

(p B/0.05). Overall, 34.6% of patients used anti-

parkinson medication (not pre-defined in the proto-

col) at any given time after baseline.

Patients displayed no statistically significant

changes in vital signs during the trial period. Treat-

ment emergent adverse events were reported in 82

patients and most frequently included anxiety

(13.1%), weight increase (9.2%), and insomnia

(8.5%). Only small increases in mean body weight

(75.79/14.0 kg at baseline vs. 75.99/14.6 kg at

endpoint) were observed. Treatment emergent im-

potence, diabetes mellitus and pain at the injection

site were also reported by one patient (0.8%) each.

According to the physician’s judgement, there was

no causal link between the death of one patient

during the trial (due to suicide) and treatment with

RLAI.

Discussion

The findings from this analysis support published

results from the StoRMi trial population [32], and

are consistent with other studies where RLAI was

given either with [29�31], or without [41], an oral

risperidone run-in. Even though all patients in the

French subgroup were required to be symptomati-

cally stable before entering the trial, and although

they were receiving oral atypical antipsychotics, they

still showed improvement when changed to RLAI.

The change to RLAI resulted in significant improve-

ments in symptom control (PANSS total score,

Marder factor scores and CGI-S score), in function-

ing capacity (GAF scores), and in health-related

0

2

4

6

8

10

12

14

16

18

20

22

Baseline (128 patients)

Month 1 (126 patients)

Month 3 (115 patients)

Month 6 (104 patients)

Endpoint (128 patients)

Mea

n PA

NS

S s

ubsc

ale

scor

es

for

Mar

der

fact

ors

Positive symptoms factor Negative symptoms factor

Disorganized thoughts factor Uncontrolled hostility/excitement factor

Anxiety/depression factor

Figure 2. PANSS subscale scores for Marder factors at each visit and at trial endpoint (pB/ 0.001 all shifts versus baseline for all factors,

except for uncontrolled hostility/excitement factor).

12.5

39.1

29.7

10.97.8

0

7.8

22.720.3 19.5

21.9

6.3

0

10

20

30

40

Sever

ely ill

Mar

kedly

ill

Mod

erat

ely ill

Mild

ly ill

Borde

rline

ill

Norm

al, n

ot a

t all i

ll

% p

atie

nts

Baseline Endpoint

Figure 3. Clinical Global Impression-Disease Severity (CGI-S) at baseline and trial endpoint (p B/0.001 all shifts versus baseline).

280 P.-M. Llorca et al.

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Page 6: Symptom control, functioning, and hospitalization status in French patients changed from oral atypical antipsychotics to risperidone long-acting injectable

quality of life (SF-36 scores) among these patients.

These improvements may account for the better

health-related quality of life experienced by patients,

and are consistent with the findings from a previous

placebo-controlled study using RLAI to treat schizo-

phrenia [31]. Improvements were achieved without

having to treat the majority of patients with the

highest recommended dose of RLAI (50 mg).

Indeed, 44.9% of patients were being treated with

the lowest available dose of RLAI (25 mg) at trial

endpoint.

The present study had a high completion rate

(70.0%), with only 3.1% of patients discontinuing

their treatment with RLAI due to non-compliance.

This compared favorably, with 64.6% who were

reported to be non-compliant on their previous

treatment despite the fact that all were receiving an

oral atypical antipsychotic. Only 6.2% of patients

discontinued their treatment with RLAI due to

insufficient efficacy, compared with 18.5% who

changed from oral atypical antipsychotics for this

reason. A small percentage of patients (2.3%)

discontinued treatment with RLAI due to adverse

events.

The beneficial effects of RLAI with respect to

adverse events may reflect the more stable drug

plasma levels achieved with RLAI compared with

oral therapy [28]. Some patients (9.2%) reported

weight increases during treatment with RLAI. How-

ever, these increases in mean body weight were small

(0.2 kg) and not significant. Furthermore, move-

ment disorders (total ESRS and Parkinsonism sub-

scale scores) among the French subgroup of patients

were also significantly reduced during treatment

with RLAI.

Patients were generally satisfied with RLAI treat-

ment, and the proportion rating their satisfaction as

‘‘very good’’ increased from 11.6% at the beginning

of the trial to 29.5% at the endpoint. Improvements

in symptom control, health-related quality of life,

and patient satisfaction, probably influenced the

better compliance with treatment seen among pa-

tients on RLAI.

The prevention of relapse in patients with schizo-

phrenia depends on compliance with treatment, and

non-compliance carries a high risk for relapse and

subsequent rehospitalization [8,10�12]. Treatment

with RLAI reduced the hospitalization rate of

patients in the French subgroup (of 66 patients

hospitalized at baseline, 51 were outpatients at

endpoint), and confirmed findings from other stu-

dies where patients were switched to RLAI from

their previous medication [32,34,35,42]. Lower

hospitalization rates would be expected to reduce

overall psychiatric healthcare costs for patients with

schizophrenia and other psychotic disorders [35].

Therefore, the option of treating patients with RLAI

could potentially result in substantial cost saving

benefits in psychiatric healthcare.

Since the present analysis showed RLAI to have

beneficial improvements over oral atypical antipsy-

chotics, we would also expect RLAI to be a success-

0

5

10

15

Physic

al fu

nctio

ning

Role p

hysic

al

Bodily

pain

Gener

al he

alth

Vitality

Social

func

tionin

g

Role e

mot

ional

Men

tal h

ealth

Physic

al co

mpo

nent

Men

tal c

ompo

nent

Mea

n ch

ange

from

bas

elin

e

Figure 4. Health-related quality of life (SF-36) at baseline and

trial endpoint (p B/0.05 shift versus baseline for all scales except

for vitality).

2

3

4

5

6

Mea

n su

bsca

le s

core

Mean total ESRS Mean Parkinsonism

Mean total ESRS 5.8 4.8 4.4 3.0 3.2

Mean Parkinsonism 4.7 3.7 3.3 2.3 2.5

Number of patients 128 127 115 104 128

Baseline Month 1 Month 3 Month 6 Endpoint

Figure 5. Total ESRS and Parkinsonism subscale scores at each study visit and trial endpoint (p B/0.001 all shifts versus baseline).

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Page 7: Symptom control, functioning, and hospitalization status in French patients changed from oral atypical antipsychotics to risperidone long-acting injectable

ful treatment intervention for patients suffering from

early schizophrenia. As patients participating in the

analysis were not in the early stages of schizophrenia,

and most had been previously hospitalized (97.7%)

up to several times (6.99/7.8 hospitalizations per

patient) for psychiatric reasons, we are unable to

elaborate further on this hypothesis.

In conclusion, RLAI is an important addition to

the options available for long-term treatment of

patients requiring antipsychotic therapy. Treatment

with RLAI is well tolerated and associated with a

high efficacy, good health-related quality of life, few

side effects (including movement disorders), and a

high level of patient satisfaction. All of these

attributes could contribute to improvements in

patient compliance with treatment. Moreover, the

ability of RLAI to improve the psychotic condition of

patients already stabilized on oral atypical antipsy-

chotics is particularly important. This was achieved

without having to treat the majority of patients with

the highest recommended dose of RLAI (50 mg). In

addition, the lower hospitalization rates among

patients treated with RLAI would be expected to

confer significant savings in the cost of psychiatric

healthcare.

Key points

. The tolerability and efficacy of risperidone

long-acting injectable (RLAI) was investigated

in French patients with schizophrenia or other

psychotic diseases

. Patients were transitioned directly to RLAI

from their previous treatment with oral atypical

antipsychotics

. RLAI significantly improved disease symptoms,

functioning and hospitalization rate in treated

patients

. Movement disorders were also significantly

reduced after treatment with RLAI

. Treatment using RLAI is a safe and effective

option for patients with schizophrenia and other

psychotic disorders

Acknowledgements

We would like to thank the French StoRMi investi-

gators group:

Dr. Isabelle Chereau, Service Hospitalier Universi-

taire, Clermont-Ferrand; Dr. Serge Schong, CMP

La Faıencerie, Mont Saint Martin; Dr. Catherine

Chassagne, CMP La Faıencerie, Mont Saint Martin;

Dr. Veronique Adnet Markovitch, CMP La Faıenc-

erie, Mont Saint Martin; Dr. Stephane Keller, CMP

La Faıencerie, Mont Saint Martin; Dr. Amal Bad-

dou, Centre Hospitalier Camille Claudel, La Cour-

onne; Dr. Paul Bonnan, Centre Hospitalier Cadillac,

Cadillac; Dr. Thierry Bottai, Centre Hospitalier de

Martigues, Hopital du Vallon, Martigues; Dr. Eric

Pellegrin, Centre Hospitalier de Martigues, Hopital

du Vallon, Martigues; Dr. Veronique Roure, Centre

Hospitalier Specialise Leon Jean Gregory, Thuir;

Dr. Rene Cariou, Centre Hospitalier Specialise Leon

Jean Gregory, Thuir; Dr. Alexandre Christodoulou,

EPS de Perray Vaucluse, Epinay Sur Orge; Dr.

Philippe Coffinet, Centre Hospitalier Specialise

Saint Remy, Saint Remy; Dr. Bruno Richelet,

Centre Hospitalier Specialise Saint Remy, Saint

Remy; Dr. Padrig Cullerre, Clinique Saint Vincent,

Larmor Plage; Prof. Jean-Marie Danion, CHRU

Hopital Civil, Strasbourg; Dr. Marie-Agathe Zim-

mermann, CHRU Hopital Civil, Strasbourg; Dr.

Renaud De Beaurepaire, Etablissement Psychiatri-

que Specialise Paul Guiraud, Villejuif; Dr. Jacques

Debieve, Centre de soins Ulysse Trelat, St Andre lez

Lille; Dr. Laurent Desbancs, CMP Du Bas Land-

reau, Reze; Dr. Dominique Drapier, CHSP Guil-

laume Regnier, Rennes; Dr. Philippe Dumont,

Centre Medico-Psychologique, Roubaix; Dr. Cathe-

rine Van Nedervelde, Centre Medico-Psycho-

logique, Roubaix; Dr. Sylvie Platteau, Centre

Medico-Psychologique, Roubaix; Dr. Xavier Xi-

beras, CH de Mont de Marsan-Site Sainte Anne,

Mont de Marsan; Dr. Philippe Durst, Centre

Hospitalier Ste Marie, Privas; Dr. Bernard Etche-

garay, Centre Hospitalier Specialise Charles Perrens,

Bordeaux; Dr. Andre Gassiot, Centre Hospitalier

Ste Marie, Rodez; Dr. Didier Mergaux, Centre

Hospitalier Ste Marie, Rodez; Dr. Alain Gavaudan,

Centre Hospitalier Specialise Valvert, Marseille; Dr.

Claude Guinard, Centre Hospitalier Specialise Val-

vert, Marseille; Dr. Jean Louis Lebeau, Centre

Hospitalier Specialise Valvert, Marseille; Dr. Nicolas

Lafay, Centre Hospitalier Henri Laborit, Poitiers;

Dr. Marie Benedicte Girard, Centre Hospitalier

Henri Laborit, Poitiers; Dr. Christian Guggiari,

Centre Hospitalier Specialise Beauregard, Bourges;

Dr. Emmanuel Dufumier, Centre Hospitalier Spe-

cialise Ste Marie, Le Puy en Velay; Dr. Rene

Clement, Centre Hospitalier Specialise Ste Marie,

Le Puy en Velay; Dr. Naceur Haddouche, Centre

Hospitalier Specialise Ste Marie, Le Puy en Velay;

Dr. Jean-Lou, Lavaud, Etablissement Psychiatrique

Specialise Paul Guiraud, Villejuif; Dr. Herve Le

Duc, Centre Psychotherapique de Gireugne, Saint

Maur; Dr. Vincent Delaunay, Centre Hospitalier

Universitaire St Jacques, Nantes; Dr. Eric Esposito,

Centre Hospitalier Universitaire St Jacques, Nantes;

Dr. Jean-Christophe Loirat, Centre Hospitalier Uni-

versitaire St Jacques, Nantes; Dr. Emile Roger

Lombertie, Centre Hospitalier Esquirol, Limoges;

Dr. Isabelle Alamome, Centre Hospitalier Esquirol,

Limoges; Dr. Pierre Chenivesse, Institut Marcel

Riviere, Le Mesnil St Denis; Dr. Eric Marcel,

Institut Marcel Riviere, Le Mesnil St Denis; Dr.

Martine Pelicier, Institut Marcel Riviere, Le Mesnil

St Denis; Dr. Jean-Albert Meynard, Hopital Marius

Lacroix, La Rochelle; Dr. Pierre Murry, CHS Saint

282 P.-M. Llorca et al.

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Page 8: Symptom control, functioning, and hospitalization status in French patients changed from oral atypical antipsychotics to risperidone long-acting injectable

Egreve, Saint Egreve; Dr. Pascal Favre, CHS Saint

Egreve, Saint Egreve; Dr. Didier Feray, Centre

Hospitalier General, Dieppe; Dr. Annie Navarre-

Coulaud, Centre Hospitalier General, Dieppe; Dr.

Michel Nguyen Thanh Tong, CHS de la Sarthe,

Allonnes; Dr. Eric Gokalsing, Centre Hospitalier

Specialise Ste Marie, Nice; Dr. Jerome Palazzolo,

Centre Hospitalier Specialise Ste Marie, Nice; Dr.

Mohammed Beyadh, Centre Hospitalier Specialise

Haute Marne, Saint-Dizier; Dr. Catherine Perdrizet

Chevallier, Centre Hospitalier Specialise Hte

Marne, Saint-Dizier; Prof. Charles-Siegfried Peretti,

Hopital Robert Debre, Reims; Dr. Claire Lise

Charrel, Hopital Robert Debre, Reims; Dr. Philippe,

Sastre Garau, Centre de Sante Mentale MGEN,

Lille; Dr. Christian Plumecocq, Centre de Sante

Mentale MGEN, Lille; Prof. Dominique Pringuey,

CHU Nice Hopital Pasteur, Nice; Dr. Michel

Benoit, CHU Nice Hopital Pasteur, Nice; Dr.

Christine Lerouge, CH Intercommunal Toulon-La

Seyne/Mer, Toulon; Dr. Philippe Raymondet, CH

Intercommunal Toulon-La Seyne/Mer, Toulon;

Dr. Dominique Robert, Centre Hospitalier de

Saumur, Saumur; Dr. Christian Amouzou, EPS

Paul Guiraud, Villejuif; Dr. Juliette Gremion, EPS

Paul Guiraud, Villejuif; Dr. Annie Ruat, EPS Paul

Guiraud, Villejuif; Dr. Anne Rauzy, EPS Paul

Guiraud, Villejuif; Dr. Mohamed Saoud, Centre

Hospitalier Specialise Le Vinatier, Bron; Dr. Halima

Zeroug Vial, Centre Hospitalier Specialise Le Vina-

tier, Bron; Dr. Helene Mandran, Centre Hospitalier

Specialise Le Vinatier, Bron; Prof. Laurent Schmitt,

Centre Casselardit, Toulouse; Dr. Virginie Rouch,

Centre Casselardit, Toulouse; Dr. Stephane Torres,

CHRU Hopital La Colombiere, Montpellier; Dr.

Jean-Philippe Boulenger, CHRU Hopital La Co-

lombiere, Montpellier; Dr. Delphine Capdevielle,

CHRU Hopital La Colombiere, Montpellier; Dr.

Yves Tyrode, Centre Hospitalier Specialise, Mont-

favet; Dr. Daniel Choain, Centre Hospitalier Spe-

cialise, Montfavet; Dr. Pierre Vaneecloo, Centre

Psychotherapeutique Duchesnois de St Saulve, St

Saulve; Dr. Annie Viala, Etablissement Psychiatri-

que Specialise Ste Anne, Paris; Dr. Laurent Masclet,

Etablissement Psychiatrique Specialise Ste Anne,

Paris.

Statement of interest

This study was supported by Janssen Cilag Medical

Affairs EMEA, Beerse, Belgium.

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