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Papers by Paul Bergmans
Progress in neuro-psychopharmacology & biological psychiatry, Jan 3, 2015
In this prospective multicentre, open-label, 6-month study (Paliperidone Palmitate Flexible Dosin... more In this prospective multicentre, open-label, 6-month study (Paliperidone Palmitate Flexible Dosing in Schizophrenia [PALMFlexS]), tolerability, safety and treatment response with paliperidone palmitate (PP) were explored in patients with acute symptoms of schizophrenia following switching from previously unsuccessful treatment with oral antipsychotics. This pragmatic study was conducted in a large, more representative sample of the general schizophrenia population compared to randomized controlled pivotal trials, to specifically mimic real-world clinical situations. After initiation on Day 1 and Day 8, patients received PP once monthly at flexible doses (50-150mgeq.) intramuscularly. The primary efficacy outcome was defined as the percentage of patients achieving ≥30% improvement in PANSS total score from baseline (BL) to last-observation-carried-forward (LOCF) endpoint (EP). Safety and tolerability assessments included Extrapyramidal Symptom Rating Scale (ESRS) total score and trea...
Journal of Psychopharmacology
PALMFlexS, a prospective multicentre, open-label, 6-month, phase IIIb interventional study, explo... more PALMFlexS, a prospective multicentre, open-label, 6-month, phase IIIb interventional study, explored tolerability, safety and treatment response in adults (n = 231) with non-acute but symptomatic schizophrenia switching to flexibly dosed paliperidone palmitate (PP) after unsuccessful treatment with risperidone long-acting injectable therapy (RLAT) or conventional depot antipsychotics (APs). Treatment response was measured by change in Positive and Negative Syndrome Scale (PANSS) total score from baseline (BL) to last-observation-carried-forward (LOCF) endpoint (EP). Safety and tolerability assessments included Extrapyramidal Symptom Rating Scale (ESRS) total score and treatment-emergent adverse events. Significant reductions in mean PANSS total score were observed for all groups (-7.5 to -10.6; p ⩽ 0.01 [BL to LOCF EP]). After switching to PP, more than 50% of all patients achieved ⩾20% and one-third of RLAT-treated patients even achieved ⩾50% improvement in PANSS total score. Across groups, there were significant improvements (p < 0.05) in symptom severity as measured by Clinical Global Impression-Severity (CGI-S; trend for improvement with RLAT; p = 0.0568), subjective well-being, medication satisfaction, and patient functioning with PP. PP was generally well tolerated. Clinically relevant benefits were observed in non-acute patients with schizophrenia switched from RLAT or conventional depot APs to PP.
EPA-1550 - Paliperidone palmitate in acute patients with schizophrenia: treatment response, safety and tolerability ? a prospective flexible-dose study in patients previously unsuccessfully treated with oral antipsychotics
European Psychiatry, 2014
ABSTRACT Introduction This study explores tolerability, safety and treatment response of flexible... more ABSTRACT Introduction This study explores tolerability, safety and treatment response of flexible doses of the atypical long-acting antipsychotic paliperidone palmitate (PP) in adult patients with an acute exacerbation of schizophrenia previously unsuccessfully treated with oral antipsychotics. Methods International prospective open-label 6-month study. Outcome parameters were change in Positive and Negative Syndrome Scale (PANSS) total score, Clinical Global Impression-Severity Scale (CGI-S), treatment-emergent adverse events (TEAEs) and weight change. Results 212 acute patients, 59.0% male, mean age 36.4 ±12.1 years, 85.4% paranoid schizophrenia were enrolled. 70.3% of patients completed the study. Most frequent reasons for early discontinuation were subject choice (9.4%), or an adverse event (9.0%). Recommended initiation regimen of PP (150 mg eq on day 1 and 100 mg eq on day 8) was administered in 92.9% of subjects. Mean baseline PANSS total score decreased from 98.5±20.1 as of day 8 of treatment to 67.4±24.0 at endpoint (mean change -31.0±28.97; 95% confidence interval [CI]-35.0;-27.1; p<0.0001). 66.7% of patients improved ≥30% in PANSS total score and percentage of patients rated markedly ill or worse in CGI-S decreased from 75.1% at baseline to 20.5% at endpoint. TEAEs reported in ≥5% were injection site pain (13.7%), insomnia (10.8%), psychotic disorder (10.4%), headache (6.1%) and anxiety (6.1%). Mean weight change at endpoint was 2.6±5.6 kg (95%CI 1.8; 3.4). Conclusions These data support results from previous randomized controlled studies that flexibly dosed paliperidone palmitate is well tolerated and associated with an early and clinically relevant treatment response in acute schizophrenia patients previously unsuccessfully treated with oral antipsychotics.
Progress in neuro-psychopharmacology & biological psychiatry, Jan 3, 2015
In this prospective multicentre, open-label, 6-month study (Paliperidone Palmitate Flexible Dosin... more In this prospective multicentre, open-label, 6-month study (Paliperidone Palmitate Flexible Dosing in Schizophrenia [PALMFlexS]), tolerability, safety and treatment response with paliperidone palmitate (PP) were explored in patients with acute symptoms of schizophrenia following switching from previously unsuccessful treatment with oral antipsychotics. This pragmatic study was conducted in a large, more representative sample of the general schizophrenia population compared to randomized controlled pivotal trials, to specifically mimic real-world clinical situations. After initiation on Day 1 and Day 8, patients received PP once monthly at flexible doses (50-150mgeq.) intramuscularly. The primary efficacy outcome was defined as the percentage of patients achieving ≥30% improvement in PANSS total score from baseline (BL) to last-observation-carried-forward (LOCF) endpoint (EP). Safety and tolerability assessments included Extrapyramidal Symptom Rating Scale (ESRS) total score and trea...
Flexibly Dosed Paliperidone Palmitate in Non-Acute but Symptomatic Patients with Schizophrenia Previously Unsuccessfully Treated with Long-Acting Injectable Risperidone
To explore tolerability, safety and treatment response of flexibly dosed paliperidone palmitate (... more To explore tolerability, safety and treatment response of flexibly dosed paliperidone palmitate (PP) in adult non-acute patients with schizophrenia previously unsuccessfully treated with the decanoate of haloperidol (Hal), flupentixol (Fpt), fluphenazine (Flu) or zuclopenthixol (Zuc).
Poster #S248 FLEXIBLY DOSED PALIPERIDONE PALMITATE IN NON-ACUTE PATIENTS WITH SCHIZOPHRENIA PREVIOUSLY UNSUCCESSFULLY TREATED WITH CONVENTIONAL DEPOT ANTIPSYCHOTICS
Schizophrenia Research, 2014
Poster #T210 PALIPERIDONE PALMITATE IN ACUTE PATIENTS WITH SCHIZOPHRENIA – TREATMENT RESPONSE, SAFETY AND TOLERABILITY: A PROSPECTIVE FLEXIBLE DOSE STUDY IN PATIENTS PREVIOUSLY UNSUCCESSFULLY TREATED WITH ORAL ANTIPSYCHOTICS
Schizophrenia Research, 2014
Poster #T209 FLEXIBLY DOSED PALIPERIDONE PALMITATE IN NON-ACUTE BUT SYMPTOMATIC PATIENTS WITH SCHIZOPHRENIA PREVIOUSLY UNSUCCESSFULLY TREATED WITH LONG-ACTING INJECTABLE RISPERIDONE
Schizophrenia Research, 2014
Neuropsychopharmacology, 2011
An open-label, randomized, active-controlled, 2-year trial evaluated 710 patients with schizophre... more An open-label, randomized, active-controlled, 2-year trial evaluated 710 patients with schizophrenia or related disorders who were switched from stable treatment with oral risperidone, olanzapine, or conventional neuroleptics to risperidone long-acting injectable (RLAI) or oral quetiapine. Primary effectiveness evaluation was time-to-relapse. Safety evaluations included adverse events (AEs) reported for the duration of the study, Extrapyramidal Symptom Rating Scale (ESRS), clinical laboratory tests, and vital signs.
Palmitate de palipéridone à doses flexibles – Réponse thérapeutique, tolérance et sécurité d’emploi: une étude prospective chez des patients en période d’exacerbation aiguë d’un trouble schizophrénique après échec d’un traitement par antipsychotiques oraux
European Psychiatry, 2013
Réponse thérapeutique, tolérance et sécurité d’emploi du palmitate de palipéridone à dose flexible : une étude prospective chez des patients adultes non-aigus atteints de schizophrénie, après échec d’un traitement par antipsychotiques oraux
European Psychiatry, 2013
P03-129 - A prospective randomized controlled trial of paliperidone ER versus oral olanzapine in patients with schizophrenia
European Psychiatry, 2010
Paliperidone Palmitate – Effect On Negative, Depression/anxiety, Patient Functioning and Extrapyramidal Symptoms in Non-acute Schizophrenia Patients Previously Unsuccessfully Treated with Oral Aripiprazole
European Psychiatry
PALMFlexS, a prospective multicentre, open-label, 6-month, phase IIIb interventional study, explo... more PALMFlexS, a prospective multicentre, open-label, 6-month, phase IIIb interventional study, explored tolerability, safety and treatment response in
adults (n = 231) with non-acute but symptomatic schizophrenia switching to flexibly dosed paliperidone palmitate (PP) after unsuccessful treatment
with risperidone long-acting injectable therapy (RLAT) or conventional depot antipsychotics (APs). Treatment response was measured by change
in Positive and Negative Syndrome Scale (PANSS) total score from baseline (BL) to last-observation-carried-forward (LOCF) endpoint (EP). Safety
and tolerability assessments included Extrapyramidal Symptom Rating Scale (ESRS) total score and treatment-emergent adverse events. Significant
reductions in mean PANSS total score were observed for all groups (–7.5 to –10.6; p ⩽ 0.01 [BL to LOCF EP]). After switching to PP, more than 50%
of all patients achieved ⩾20% and one-third of RLAT-treated patients even achieved ⩾50% improvement in PANSS total score. Across groups, there
were significant improvements (p < 0.05) in symptom severity as measured by Clinical Global Impression-Severity (CGI-S; trend for improvement with
RLAT; p = 0.0568), subjective well-being, medication satisfaction, and patient functioning with PP. PP was generally well tolerated. Clinically relevant
benefits were observed in non-acute patients with schizophrenia switched from RLAT or conventional depot APs to PP.
EPA-1545 - Functional outcomes with once-monthly paliperidone palmitate in acute and in non-acute patients with schizophrenia previously unsuccessfully treated with oral antipsychotics
European Psychiatry, 2014
ABSTRACT Introduction Effective antipsychotic treatment of schizophrenia should, beyond symptom c... more ABSTRACT Introduction Effective antipsychotic treatment of schizophrenia should, beyond symptom control, translate into meaningful functional improvements. This study explored functional outcomes in patients with schizophrenia switched from previous unsuccessful treatment with oral antipsychotics to flexible doses of paliperidone palmitate (PP). Methods Two groups of acute (N=212) and non-acute (N=593) patients from an international prospective open-label 6-month study. Outcomes were change in Positive and Negative Syndrome Scale (PANSS) total score, Personal and Psychosocial Performance scale (PSP) and Mini International Classification of Functionality, Disability and Health Rating for Activity and Participation Disorders in Psychological Illnesses (Mini-ICF-APP). Results Both groups significantly improved from baseline to endpoint in mean PANSS total score from 98.5±20.1 to 67.4±24.0 (mean change -31.0±29.0) in acute and from 71.5±14.6 to 59.7±18.1 (mean change -11.7±15.9) in non-acute patients (all p<0.0001). Patient functioning in PSP total score increased from 43.9±15.0 at baseline to 62.9±17.1 at endpoint (mean change 19.0±18.7; 95% confidence interval [CI] 16.4;21.6) in the acute and from 58.1±13.4 at baseline to 66.1±15.7 at endpoint (mean change 8.0±14.0; 95%CI 6.8;9.1) in the non-acute group (both groups p<0.0001). Illness-related disabilities of activity and participation within groups improved significantly in Mini-ICF-APP global score decreasing from 26.8±8.5 to 18.5±9.8 (mean change -8.0±10.4; 95%CI -9.5;-6.5) in acute and from 19.8±7.9 to 15.9±8.8 (mean change: -4.0±7.5; 95%CI - 4.6;-3.3) from baseline to endpoint in non-acute patients (both groups p<0.0001). Conclusions Symptom reduction in acute and non-acute patients with schizophrenia treated with PP after previous unsuccessful treatment with oral antipsychotics was associated with clinically meaningful functional improvements.
EPA-1546 - Paliperidone palmitate in non-acute but symptomatic patients with schizophrenia previously unsuccessfully treated with oral aripiprazole
European Psychiatry, 2014
ABSTRACT Introduction To explore tolerability, safety and treatment response of flexibly dosed on... more ABSTRACT Introduction To explore tolerability, safety and treatment response of flexibly dosed once-monthly paliperidone palmitate (PP) in adult nonacute patients with schizophrenia previously unsuccessfully treated with oral aripiprazole. Methods International prospective open-label 6-month study. Outcomes were change in Positive and Negative Syndrome Scale (PANSS), patient functioning (Personal and Social Performance Scale; PSP), disease severity (CGI-S and CGI-C), Extrapyramidal Symptom Rating Scale (ESRS) and treatment-emergent adverse events (TEAEs). Results 46 patients (73.9% male, mean age 34.4±9.4 years, 78.3% paranoid schizophrenia) were analyzed. The mean prior oral aripiprazole dose was 22.7±10.7 mg/day. 67.4% of patients completed the study. Mean PANSS total score decreased from 74.7±14.9 at baseline to 62.6±16.5 at LOCF endpoint (mean change -12.2±16.7; 95% confidence interval -17.1;-7.2; p<0.0001). 52.2% of patients showed a ≥20% improvement in PANSS total score, the percentage of patients rated mildly ill or less in CGI-S increased from 23.9% to 56.5% and 75.5% of patients were rated improved in CGI-C. Patient functioning in PSP improved from 58.9±13.4 to 62.9±15.2 (p=0.041). TEAEs reported in ≥5% were anxiety (n=6), injection site pain, bronchitis, insomnia and akathisia (n=4 each), and weight increase, depression and pain in extremities (n=3 each). Extrapyramidal symptoms measured by ESRS total scores improved significantly in completers from baseline to month 6 by -1.4±2.7 (p<0.007) and by -0.6±3.4 from baseline to LOCF endpoint (p=0.046). Conclusions Flexibly dosed paliperidone palmitate was well tolerated and associated with a clinically relevant symptomatic treatment response, improved functioning and less EPS in non-acute patients with schizophrenia previously unsuccessfully treated with oral aripiprazole.
EPA-1548 - Flexibly dosed paliperidone palmitate in non-acute patients with schizophrenia switched from previously unsuccessful monotherapy with oral atypical antipsychotics
European Psychiatry, 2014
ABSTRACT Introduction To explore tolerability, safety and treatment response of flexibly dosed pa... more ABSTRACT Introduction To explore tolerability, safety and treatment response of flexibly dosed paliperidone palmitate (PP) in adult non-acute schizophrenia patients previously unsuccessfully treated with oral antipsychotic monotherapy of risperidone (RIS), paliperidone ER (Pali ER), olanzapine (OLA), quetiapine (QUE) or aripiprazole (ARI). Methods International, prospective 6-month open-label study. Outcomes were response (≥20% improvement in Positive and Negative Syndrome Scale (PANSS) total score at endpoint), patient functioning (Personal and Social Performance scale (PSP)), treatment-emergent adverse events (TEAEs) and Extrapyramidal Symptom Rating Scale (ESRS). Results Intent-to-treat population: n=191 (RIS), n=104 (Pali ER), n=87 (OLA), n=46 (ARI), n=44 (QUE). Patients presented some differences in baseline demographics, e.g. in age, years since diagnosis and BMI. Baseline mean PANSS total scores ranged from 74.7±14.9 (ARI) to 70.8±13.1 (QUE) and 70.8±15.1 (RIS). Between 67.4% (ARI) and 83.2% (RIS) of patients completed the study. At endpoint, 74% (RIS), 58% (Pali ER), 61% (OLA), 66% (QUE) and 52% (ARI) of patients had improved ≥20% in PANSS total score. Mean PSP improvement at endpoint was: 10.4±13.8 (RIS), 7.0±13.8 (Pali ER), 4.5±15.9 (OLA), 7.9±12.4 (QUE) and 3.9±13.2 (ARI); all p<0.05. TEAEs reported at least once in all subgroups were injection site pain, insomnia and psychotic disorder. Mean change in ESRS from baseline to endpoint was -1.2±3.5 (RIS), - 0.7±4.1 (Pali ER), -1.3±4.4 (OLA), -0.3±3.2 (QUE) and -0.6±3.4 (ARI; p<0.05 for all except QUE). Conclusion
EPA-1550 - Paliperidone palmitate in acute patients with schizophrenia: treatment response, safety and tolerability ? a prospective flexible-dose study in patients previously unsuccessfully treated with oral antipsychotics
European Psychiatry, 2014
ABSTRACT Introduction This study explores tolerability, safety and treatment response of flexible... more ABSTRACT Introduction This study explores tolerability, safety and treatment response of flexible doses of the atypical long-acting antipsychotic paliperidone palmitate (PP) in adult patients with an acute exacerbation of schizophrenia previously unsuccessfully treated with oral antipsychotics. Methods International prospective open-label 6-month study. Outcome parameters were change in Positive and Negative Syndrome Scale (PANSS) total score, Clinical Global Impression-Severity Scale (CGI-S), treatment-emergent adverse events (TEAEs) and weight change. Results 212 acute patients, 59.0% male, mean age 36.4 ±12.1 years, 85.4% paranoid schizophrenia were enrolled. 70.3% of patients completed the study. Most frequent reasons for early discontinuation were subject choice (9.4%), or an adverse event (9.0%). Recommended initiation regimen of PP (150 mg eq on day 1 and 100 mg eq on day 8) was administered in 92.9% of subjects. Mean baseline PANSS total score decreased from 98.5±20.1 as of day 8 of treatment to 67.4±24.0 at endpoint (mean change -31.0±28.97; 95% confidence interval [CI]-35.0;-27.1; p<0.0001). 66.7% of patients improved ≥30% in PANSS total score and percentage of patients rated markedly ill or worse in CGI-S decreased from 75.1% at baseline to 20.5% at endpoint. TEAEs reported in ≥5% were injection site pain (13.7%), insomnia (10.8%), psychotic disorder (10.4%), headache (6.1%) and anxiety (6.1%). Mean weight change at endpoint was 2.6±5.6 kg (95%CI 1.8; 3.4). Conclusions These data support results from previous randomized controlled studies that flexibly dosed paliperidone palmitate is well tolerated and associated with an early and clinically relevant treatment response in acute schizophrenia patients previously unsuccessfully treated with oral antipsychotics.
European Psychiatry, 2014
Introduction: Negative, disorganized and depressive symptoms are among the major unmet needs in t... more Introduction: Negative, disorganized and depressive symptoms are among the major unmet needs in the treatment of patients with schizophrenia. The objective of this analysis was to explore the impact of flexibly dosed paliperidone palmitate (PP) on negative and depressive symptoms, disorganized thoughts, subjective well-being and treatment satisfaction in adult non-acute but symptomatic patients with schizophrenia previously unsuccessfully treated with oral antipsychotics.
Progress in neuro-psychopharmacology & biological psychiatry, Jan 3, 2015
In this prospective multicentre, open-label, 6-month study (Paliperidone Palmitate Flexible Dosin... more In this prospective multicentre, open-label, 6-month study (Paliperidone Palmitate Flexible Dosing in Schizophrenia [PALMFlexS]), tolerability, safety and treatment response with paliperidone palmitate (PP) were explored in patients with acute symptoms of schizophrenia following switching from previously unsuccessful treatment with oral antipsychotics. This pragmatic study was conducted in a large, more representative sample of the general schizophrenia population compared to randomized controlled pivotal trials, to specifically mimic real-world clinical situations. After initiation on Day 1 and Day 8, patients received PP once monthly at flexible doses (50-150mgeq.) intramuscularly. The primary efficacy outcome was defined as the percentage of patients achieving ≥30% improvement in PANSS total score from baseline (BL) to last-observation-carried-forward (LOCF) endpoint (EP). Safety and tolerability assessments included Extrapyramidal Symptom Rating Scale (ESRS) total score and trea...
Journal of Psychopharmacology
PALMFlexS, a prospective multicentre, open-label, 6-month, phase IIIb interventional study, explo... more PALMFlexS, a prospective multicentre, open-label, 6-month, phase IIIb interventional study, explored tolerability, safety and treatment response in adults (n = 231) with non-acute but symptomatic schizophrenia switching to flexibly dosed paliperidone palmitate (PP) after unsuccessful treatment with risperidone long-acting injectable therapy (RLAT) or conventional depot antipsychotics (APs). Treatment response was measured by change in Positive and Negative Syndrome Scale (PANSS) total score from baseline (BL) to last-observation-carried-forward (LOCF) endpoint (EP). Safety and tolerability assessments included Extrapyramidal Symptom Rating Scale (ESRS) total score and treatment-emergent adverse events. Significant reductions in mean PANSS total score were observed for all groups (-7.5 to -10.6; p ⩽ 0.01 [BL to LOCF EP]). After switching to PP, more than 50% of all patients achieved ⩾20% and one-third of RLAT-treated patients even achieved ⩾50% improvement in PANSS total score. Across groups, there were significant improvements (p < 0.05) in symptom severity as measured by Clinical Global Impression-Severity (CGI-S; trend for improvement with RLAT; p = 0.0568), subjective well-being, medication satisfaction, and patient functioning with PP. PP was generally well tolerated. Clinically relevant benefits were observed in non-acute patients with schizophrenia switched from RLAT or conventional depot APs to PP.
EPA-1550 - Paliperidone palmitate in acute patients with schizophrenia: treatment response, safety and tolerability ? a prospective flexible-dose study in patients previously unsuccessfully treated with oral antipsychotics
European Psychiatry, 2014
ABSTRACT Introduction This study explores tolerability, safety and treatment response of flexible... more ABSTRACT Introduction This study explores tolerability, safety and treatment response of flexible doses of the atypical long-acting antipsychotic paliperidone palmitate (PP) in adult patients with an acute exacerbation of schizophrenia previously unsuccessfully treated with oral antipsychotics. Methods International prospective open-label 6-month study. Outcome parameters were change in Positive and Negative Syndrome Scale (PANSS) total score, Clinical Global Impression-Severity Scale (CGI-S), treatment-emergent adverse events (TEAEs) and weight change. Results 212 acute patients, 59.0% male, mean age 36.4 ±12.1 years, 85.4% paranoid schizophrenia were enrolled. 70.3% of patients completed the study. Most frequent reasons for early discontinuation were subject choice (9.4%), or an adverse event (9.0%). Recommended initiation regimen of PP (150 mg eq on day 1 and 100 mg eq on day 8) was administered in 92.9% of subjects. Mean baseline PANSS total score decreased from 98.5±20.1 as of day 8 of treatment to 67.4±24.0 at endpoint (mean change -31.0±28.97; 95% confidence interval [CI]-35.0;-27.1; p<0.0001). 66.7% of patients improved ≥30% in PANSS total score and percentage of patients rated markedly ill or worse in CGI-S decreased from 75.1% at baseline to 20.5% at endpoint. TEAEs reported in ≥5% were injection site pain (13.7%), insomnia (10.8%), psychotic disorder (10.4%), headache (6.1%) and anxiety (6.1%). Mean weight change at endpoint was 2.6±5.6 kg (95%CI 1.8; 3.4). Conclusions These data support results from previous randomized controlled studies that flexibly dosed paliperidone palmitate is well tolerated and associated with an early and clinically relevant treatment response in acute schizophrenia patients previously unsuccessfully treated with oral antipsychotics.
Progress in neuro-psychopharmacology & biological psychiatry, Jan 3, 2015
In this prospective multicentre, open-label, 6-month study (Paliperidone Palmitate Flexible Dosin... more In this prospective multicentre, open-label, 6-month study (Paliperidone Palmitate Flexible Dosing in Schizophrenia [PALMFlexS]), tolerability, safety and treatment response with paliperidone palmitate (PP) were explored in patients with acute symptoms of schizophrenia following switching from previously unsuccessful treatment with oral antipsychotics. This pragmatic study was conducted in a large, more representative sample of the general schizophrenia population compared to randomized controlled pivotal trials, to specifically mimic real-world clinical situations. After initiation on Day 1 and Day 8, patients received PP once monthly at flexible doses (50-150mgeq.) intramuscularly. The primary efficacy outcome was defined as the percentage of patients achieving ≥30% improvement in PANSS total score from baseline (BL) to last-observation-carried-forward (LOCF) endpoint (EP). Safety and tolerability assessments included Extrapyramidal Symptom Rating Scale (ESRS) total score and trea...
Flexibly Dosed Paliperidone Palmitate in Non-Acute but Symptomatic Patients with Schizophrenia Previously Unsuccessfully Treated with Long-Acting Injectable Risperidone
To explore tolerability, safety and treatment response of flexibly dosed paliperidone palmitate (... more To explore tolerability, safety and treatment response of flexibly dosed paliperidone palmitate (PP) in adult non-acute patients with schizophrenia previously unsuccessfully treated with the decanoate of haloperidol (Hal), flupentixol (Fpt), fluphenazine (Flu) or zuclopenthixol (Zuc).
Poster #S248 FLEXIBLY DOSED PALIPERIDONE PALMITATE IN NON-ACUTE PATIENTS WITH SCHIZOPHRENIA PREVIOUSLY UNSUCCESSFULLY TREATED WITH CONVENTIONAL DEPOT ANTIPSYCHOTICS
Schizophrenia Research, 2014
Poster #T210 PALIPERIDONE PALMITATE IN ACUTE PATIENTS WITH SCHIZOPHRENIA – TREATMENT RESPONSE, SAFETY AND TOLERABILITY: A PROSPECTIVE FLEXIBLE DOSE STUDY IN PATIENTS PREVIOUSLY UNSUCCESSFULLY TREATED WITH ORAL ANTIPSYCHOTICS
Schizophrenia Research, 2014
Poster #T209 FLEXIBLY DOSED PALIPERIDONE PALMITATE IN NON-ACUTE BUT SYMPTOMATIC PATIENTS WITH SCHIZOPHRENIA PREVIOUSLY UNSUCCESSFULLY TREATED WITH LONG-ACTING INJECTABLE RISPERIDONE
Schizophrenia Research, 2014
Neuropsychopharmacology, 2011
An open-label, randomized, active-controlled, 2-year trial evaluated 710 patients with schizophre... more An open-label, randomized, active-controlled, 2-year trial evaluated 710 patients with schizophrenia or related disorders who were switched from stable treatment with oral risperidone, olanzapine, or conventional neuroleptics to risperidone long-acting injectable (RLAI) or oral quetiapine. Primary effectiveness evaluation was time-to-relapse. Safety evaluations included adverse events (AEs) reported for the duration of the study, Extrapyramidal Symptom Rating Scale (ESRS), clinical laboratory tests, and vital signs.
Palmitate de palipéridone à doses flexibles – Réponse thérapeutique, tolérance et sécurité d’emploi: une étude prospective chez des patients en période d’exacerbation aiguë d’un trouble schizophrénique après échec d’un traitement par antipsychotiques oraux
European Psychiatry, 2013
Réponse thérapeutique, tolérance et sécurité d’emploi du palmitate de palipéridone à dose flexible : une étude prospective chez des patients adultes non-aigus atteints de schizophrénie, après échec d’un traitement par antipsychotiques oraux
European Psychiatry, 2013
P03-129 - A prospective randomized controlled trial of paliperidone ER versus oral olanzapine in patients with schizophrenia
European Psychiatry, 2010
Paliperidone Palmitate – Effect On Negative, Depression/anxiety, Patient Functioning and Extrapyramidal Symptoms in Non-acute Schizophrenia Patients Previously Unsuccessfully Treated with Oral Aripiprazole
European Psychiatry
PALMFlexS, a prospective multicentre, open-label, 6-month, phase IIIb interventional study, explo... more PALMFlexS, a prospective multicentre, open-label, 6-month, phase IIIb interventional study, explored tolerability, safety and treatment response in
adults (n = 231) with non-acute but symptomatic schizophrenia switching to flexibly dosed paliperidone palmitate (PP) after unsuccessful treatment
with risperidone long-acting injectable therapy (RLAT) or conventional depot antipsychotics (APs). Treatment response was measured by change
in Positive and Negative Syndrome Scale (PANSS) total score from baseline (BL) to last-observation-carried-forward (LOCF) endpoint (EP). Safety
and tolerability assessments included Extrapyramidal Symptom Rating Scale (ESRS) total score and treatment-emergent adverse events. Significant
reductions in mean PANSS total score were observed for all groups (–7.5 to –10.6; p ⩽ 0.01 [BL to LOCF EP]). After switching to PP, more than 50%
of all patients achieved ⩾20% and one-third of RLAT-treated patients even achieved ⩾50% improvement in PANSS total score. Across groups, there
were significant improvements (p < 0.05) in symptom severity as measured by Clinical Global Impression-Severity (CGI-S; trend for improvement with
RLAT; p = 0.0568), subjective well-being, medication satisfaction, and patient functioning with PP. PP was generally well tolerated. Clinically relevant
benefits were observed in non-acute patients with schizophrenia switched from RLAT or conventional depot APs to PP.
EPA-1545 - Functional outcomes with once-monthly paliperidone palmitate in acute and in non-acute patients with schizophrenia previously unsuccessfully treated with oral antipsychotics
European Psychiatry, 2014
ABSTRACT Introduction Effective antipsychotic treatment of schizophrenia should, beyond symptom c... more ABSTRACT Introduction Effective antipsychotic treatment of schizophrenia should, beyond symptom control, translate into meaningful functional improvements. This study explored functional outcomes in patients with schizophrenia switched from previous unsuccessful treatment with oral antipsychotics to flexible doses of paliperidone palmitate (PP). Methods Two groups of acute (N=212) and non-acute (N=593) patients from an international prospective open-label 6-month study. Outcomes were change in Positive and Negative Syndrome Scale (PANSS) total score, Personal and Psychosocial Performance scale (PSP) and Mini International Classification of Functionality, Disability and Health Rating for Activity and Participation Disorders in Psychological Illnesses (Mini-ICF-APP). Results Both groups significantly improved from baseline to endpoint in mean PANSS total score from 98.5±20.1 to 67.4±24.0 (mean change -31.0±29.0) in acute and from 71.5±14.6 to 59.7±18.1 (mean change -11.7±15.9) in non-acute patients (all p<0.0001). Patient functioning in PSP total score increased from 43.9±15.0 at baseline to 62.9±17.1 at endpoint (mean change 19.0±18.7; 95% confidence interval [CI] 16.4;21.6) in the acute and from 58.1±13.4 at baseline to 66.1±15.7 at endpoint (mean change 8.0±14.0; 95%CI 6.8;9.1) in the non-acute group (both groups p<0.0001). Illness-related disabilities of activity and participation within groups improved significantly in Mini-ICF-APP global score decreasing from 26.8±8.5 to 18.5±9.8 (mean change -8.0±10.4; 95%CI -9.5;-6.5) in acute and from 19.8±7.9 to 15.9±8.8 (mean change: -4.0±7.5; 95%CI - 4.6;-3.3) from baseline to endpoint in non-acute patients (both groups p<0.0001). Conclusions Symptom reduction in acute and non-acute patients with schizophrenia treated with PP after previous unsuccessful treatment with oral antipsychotics was associated with clinically meaningful functional improvements.
EPA-1546 - Paliperidone palmitate in non-acute but symptomatic patients with schizophrenia previously unsuccessfully treated with oral aripiprazole
European Psychiatry, 2014
ABSTRACT Introduction To explore tolerability, safety and treatment response of flexibly dosed on... more ABSTRACT Introduction To explore tolerability, safety and treatment response of flexibly dosed once-monthly paliperidone palmitate (PP) in adult nonacute patients with schizophrenia previously unsuccessfully treated with oral aripiprazole. Methods International prospective open-label 6-month study. Outcomes were change in Positive and Negative Syndrome Scale (PANSS), patient functioning (Personal and Social Performance Scale; PSP), disease severity (CGI-S and CGI-C), Extrapyramidal Symptom Rating Scale (ESRS) and treatment-emergent adverse events (TEAEs). Results 46 patients (73.9% male, mean age 34.4±9.4 years, 78.3% paranoid schizophrenia) were analyzed. The mean prior oral aripiprazole dose was 22.7±10.7 mg/day. 67.4% of patients completed the study. Mean PANSS total score decreased from 74.7±14.9 at baseline to 62.6±16.5 at LOCF endpoint (mean change -12.2±16.7; 95% confidence interval -17.1;-7.2; p<0.0001). 52.2% of patients showed a ≥20% improvement in PANSS total score, the percentage of patients rated mildly ill or less in CGI-S increased from 23.9% to 56.5% and 75.5% of patients were rated improved in CGI-C. Patient functioning in PSP improved from 58.9±13.4 to 62.9±15.2 (p=0.041). TEAEs reported in ≥5% were anxiety (n=6), injection site pain, bronchitis, insomnia and akathisia (n=4 each), and weight increase, depression and pain in extremities (n=3 each). Extrapyramidal symptoms measured by ESRS total scores improved significantly in completers from baseline to month 6 by -1.4±2.7 (p<0.007) and by -0.6±3.4 from baseline to LOCF endpoint (p=0.046). Conclusions Flexibly dosed paliperidone palmitate was well tolerated and associated with a clinically relevant symptomatic treatment response, improved functioning and less EPS in non-acute patients with schizophrenia previously unsuccessfully treated with oral aripiprazole.
EPA-1548 - Flexibly dosed paliperidone palmitate in non-acute patients with schizophrenia switched from previously unsuccessful monotherapy with oral atypical antipsychotics
European Psychiatry, 2014
ABSTRACT Introduction To explore tolerability, safety and treatment response of flexibly dosed pa... more ABSTRACT Introduction To explore tolerability, safety and treatment response of flexibly dosed paliperidone palmitate (PP) in adult non-acute schizophrenia patients previously unsuccessfully treated with oral antipsychotic monotherapy of risperidone (RIS), paliperidone ER (Pali ER), olanzapine (OLA), quetiapine (QUE) or aripiprazole (ARI). Methods International, prospective 6-month open-label study. Outcomes were response (≥20% improvement in Positive and Negative Syndrome Scale (PANSS) total score at endpoint), patient functioning (Personal and Social Performance scale (PSP)), treatment-emergent adverse events (TEAEs) and Extrapyramidal Symptom Rating Scale (ESRS). Results Intent-to-treat population: n=191 (RIS), n=104 (Pali ER), n=87 (OLA), n=46 (ARI), n=44 (QUE). Patients presented some differences in baseline demographics, e.g. in age, years since diagnosis and BMI. Baseline mean PANSS total scores ranged from 74.7±14.9 (ARI) to 70.8±13.1 (QUE) and 70.8±15.1 (RIS). Between 67.4% (ARI) and 83.2% (RIS) of patients completed the study. At endpoint, 74% (RIS), 58% (Pali ER), 61% (OLA), 66% (QUE) and 52% (ARI) of patients had improved ≥20% in PANSS total score. Mean PSP improvement at endpoint was: 10.4±13.8 (RIS), 7.0±13.8 (Pali ER), 4.5±15.9 (OLA), 7.9±12.4 (QUE) and 3.9±13.2 (ARI); all p<0.05. TEAEs reported at least once in all subgroups were injection site pain, insomnia and psychotic disorder. Mean change in ESRS from baseline to endpoint was -1.2±3.5 (RIS), - 0.7±4.1 (Pali ER), -1.3±4.4 (OLA), -0.3±3.2 (QUE) and -0.6±3.4 (ARI; p<0.05 for all except QUE). Conclusion
EPA-1550 - Paliperidone palmitate in acute patients with schizophrenia: treatment response, safety and tolerability ? a prospective flexible-dose study in patients previously unsuccessfully treated with oral antipsychotics
European Psychiatry, 2014
ABSTRACT Introduction This study explores tolerability, safety and treatment response of flexible... more ABSTRACT Introduction This study explores tolerability, safety and treatment response of flexible doses of the atypical long-acting antipsychotic paliperidone palmitate (PP) in adult patients with an acute exacerbation of schizophrenia previously unsuccessfully treated with oral antipsychotics. Methods International prospective open-label 6-month study. Outcome parameters were change in Positive and Negative Syndrome Scale (PANSS) total score, Clinical Global Impression-Severity Scale (CGI-S), treatment-emergent adverse events (TEAEs) and weight change. Results 212 acute patients, 59.0% male, mean age 36.4 ±12.1 years, 85.4% paranoid schizophrenia were enrolled. 70.3% of patients completed the study. Most frequent reasons for early discontinuation were subject choice (9.4%), or an adverse event (9.0%). Recommended initiation regimen of PP (150 mg eq on day 1 and 100 mg eq on day 8) was administered in 92.9% of subjects. Mean baseline PANSS total score decreased from 98.5±20.1 as of day 8 of treatment to 67.4±24.0 at endpoint (mean change -31.0±28.97; 95% confidence interval [CI]-35.0;-27.1; p<0.0001). 66.7% of patients improved ≥30% in PANSS total score and percentage of patients rated markedly ill or worse in CGI-S decreased from 75.1% at baseline to 20.5% at endpoint. TEAEs reported in ≥5% were injection site pain (13.7%), insomnia (10.8%), psychotic disorder (10.4%), headache (6.1%) and anxiety (6.1%). Mean weight change at endpoint was 2.6±5.6 kg (95%CI 1.8; 3.4). Conclusions These data support results from previous randomized controlled studies that flexibly dosed paliperidone palmitate is well tolerated and associated with an early and clinically relevant treatment response in acute schizophrenia patients previously unsuccessfully treated with oral antipsychotics.
European Psychiatry, 2014
Introduction: Negative, disorganized and depressive symptoms are among the major unmet needs in t... more Introduction: Negative, disorganized and depressive symptoms are among the major unmet needs in the treatment of patients with schizophrenia. The objective of this analysis was to explore the impact of flexibly dosed paliperidone palmitate (PP) on negative and depressive symptoms, disorganized thoughts, subjective well-being and treatment satisfaction in adult non-acute but symptomatic patients with schizophrenia previously unsuccessfully treated with oral antipsychotics.