Patients in the early phases of schizophrenia and schizoaffective disorders effectively treated with risperidone long-acting injectable

2005 ◽  
Vol 19 (5_suppl) ◽  
pp. 5-14 ◽  
Author(s):  
E. Parellada ◽  
R. Andrezina ◽  
V. Milanova ◽  
P. Glue ◽  
M. Masiak ◽  
...  
Keyword(s):  
Symptom Improvement ◽  
Treatment Change ◽  
Open Label ◽  
Schizoaffective Disorders ◽  
Direct Initiation ◽  
Syndrome Scale ◽  
Previous Medication ◽  
Long Acting ◽  
Negative Syndrome ◽  
Early Phases

The efficacy and safety of risperidone long-acting injectable (RLAI) was investigated in patients in the early phases of schizophrenia and schizoaffective disorders (≤ 3 years). Patients who required a treatment change received RLAI (2-weekly gluteal injections of 25, 37.5 or 50mg, per clinical judgement), without an oral risperidone run-in phase. A total of 382 patients were included in this 6-month open-label study; 73% of patients completed the study. A total of 84% had schizophrenia with a median duration of 1.0 year since diagnosis. Previous medications were mainly atypical antipsychotics (70%) and depot neuroleptics (24%). The main reasons for treatment change were non-compliance (42%) and insufficient efficacy (31%) of previous medication. The total Positive and Negative Syndrome Scale (PANSS) and all its subscale scores improved significantly (p ≤ 0.0001), with 40% of patients showing a 20% improvement on total PANSS. Global Assessment of Functioning, quality of life, patient satisfaction and movement disorders also improved significantly. Tolerability of RLAI was generally good and no unexpected adverse events were reported. The ensured delivery of medication with RLAI resulted in significant symptom improvement in this patient population. Direct initiation of RLAI is well accepted by patients. RLAI might represent a novel option for patients in the early phases of psychosis.

scholarly journals Risperidone Long-acting Injectable in Stable Patients with Schizophrenia from Related Disorders Switched from Oral Olanzapine

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1
Author(s):  
F. Rosa ◽  
P. Thomas ◽  
A. Schreiner ◽  
T. Sherif
Keyword(s):  
Psychotic Disorders ◽  
Functional Improvement ◽  
Efficacy Evaluation ◽  
Treatment Change ◽  
Open Label ◽  
Oral Olanzapine ◽  
Syndrome Scale ◽  
Secondary Endpoints ◽  
Long Acting ◽  
Lost To Follow Up

Objective:To explore the efficacy of risperidone long-acting injectable (RLAI) in patients previously treated with oral olanzapine requiring therapy change.Methods:This 6-month, multicenter, prospective, open-label trial evaluated adult patients with psychotic disorders treated with a stable dose of olanzapine, who required a treatment change due to lack of efficacy and/or tolerability. Three weeks after RLAI initiation, olanzapine use was tapered over 1 or 3 weeks at the discretion of the investigator. Primary efficacy evaluation was Positive and Negative Syndrome Scale (PANSS) total score change. Secondary endpoints included PANSS subscales, Clinical Global Impression-Severity (CGI-S), and Global Assessment of Functioning (GAF). Safety was evaluated by recording treatment-emergent adverse events (TEAEs).Results:96 patients were enrolled (53 tapered olanzapine within 1-week and 43 over 3-weeks). Mean olanzapine baseline dose was 19.2±11.8 and 29.9±17.5 mg/day in 1-week tapering and 3-week tapering groups, respectively. 40.6% of patients were initiated on 25 mg RLAI every-two-weeks. Treatment was completed by 79 patients (82.3%). Treatment discontinuation was mainly due to withdrawal of consent (n=4), AE (n=3), injection refusal (n=2), or lost to follow-up (n=2). Improvements in PANSS total and subscale scores, CGI-S and GAF were significant from baseline to endpoint (p< 0.0001). 74 TEAEs were reported in 42 patients (42.9%). TEAEs reported in ≥2% of patients were agitation (3.6%), insomnia (3.6%), and schizophrenia (9.1%). Serious AEs occurred in 10 patients.Conclusions:Switching treatment from oral olanzapine to RLAI led to clinically-relevant symptomatic and functional improvement in more than half of all patients. RLAI treatment was generally well-tolerated.

Patients with schizophrenia previously stabilized on conventional depot antipsychotics experience significant clinical improvements following treatment with long-acting risperidone

2004 ◽  
Vol 19 (4) ◽  
pp. 219-225 ◽  
Author(s):  
Robert A. Lasser ◽  
Cynthia A. Bossie ◽  
Georges M. Gharabawi ◽  
Martin Turner
Keyword(s):  
Open Label ◽  
Open Label Study ◽  
Safety And Efficacy ◽  
Partial Compliance ◽  
Syndrome Scale ◽  
Depot Antipsychotic ◽  
Long Acting ◽  
Negative Syndrome ◽  
To Receive ◽  
Depot Antipsychotics

AbstractBackgroundConventional depot antipsychotics can provide constant pharmacologic treatment, eliminating partial compliance and reducing relapse risk. Atypical antipsychotics, have improved clinical profiles but require daily dosing, compromising their overall effectiveness. As oral risperidone provides safety and efficacy benefits over oral haloperidol, improvements may be realized by replacing conventional with atypical agents in long-acting therapy. This report examines 50-weeks of long-acting risperidone therapy in patients previously stabilized with conventional depot antipsychotics.MethodsA multi-center, open-label study enrolled 725 patients with schizophrenia or schizoaffective disorder, judged clinically stable and maintained on stable antipsychotic doses for ≥4 weeks. Assignment by clinician judgment to receive 25–75 mg of long-acting risperidone every 2 weeks for 50 weeks followed, with performance of standard safety and efficacy assessments. Data are presented on patients receiving conventional depot antipsychotic monotherapy at study entry.ResultsIn the 188 (25.9%) patients receiving conventional depot antipsychotic monotherapy at entry, mild-to-moderate mean (±S.D.) Positive and Negative Syndrome Scale (PANSS)-total scores improved significantly after receiving long-acting risperidone (64.2 ± 18.9 to 58.2 ± 20.3; P < 0.001). Clinical improvement of ≥20%, 40%, or 60% reduction in PANSS-total score, occurred in 52%, 34%, and 16% of patients, respectively. ESRS subjective ratings and objective physician ratings (Parkinsonism) decreased significantly (P < 0.001).ConclusionStable patients with mild, residual symptomatology treated with conventional depot antipsychotics experienced significant improvement in psychiatric and movement disorder symptomatology following 1-year of treatment with long-acting risperidone.

Long-term safety and tolerability of iloperidone: results from a 25-week, open-label extension trial

CNS Spectrums ◽  
2013 ◽  
Vol 18 (1) ◽  
pp. 43-54 ◽  
Author(s):  
Andrew J. Cutler ◽  
Amir H. Kalali ◽  
Greg W. Mattingly ◽  
Jelena Kunovac ◽  
Xiangyi Meng
Keyword(s):  
Serum Glucose ◽  
Favorable Effect ◽  
Controlled Clinical Trial ◽  
Open Label ◽  
Once Daily ◽  
Syndrome Scale ◽  
Open Label Extension ◽  
Negative Syndrome ◽  
Extension Trial

Introduction/ObjectiveLong-term use of the atypical antipsychotic iloperidone has not been investigated at doses above 16 mg/d. This article describes safety and tolerability results from the 25-week open-label extension of a 4-week placebo- and ziprasidone-controlled clinical trial of iloperidone.MethodsPatients received a dose of 24 mg/d (given as 12 mg twice daily; mean dose = 21.6 mg) that could be reduced to 12 mg/d (given once daily at bedtime) any time after day 35 at the investigator's discretion.ResultsA total of 72/173 patients (41.6%) completed the open-label extension. Treatment-emergent adverse events (TEAEs), most mild to moderate in severity, included headache (13.9%), weight increase (9.2%), dizziness (6.9%), nausea (6.4%), sedation (6.4%), and insomnia (5.2%). The only notable dose-related TEAEs were increased weight and headache. Levels of serum glucose, lipids, and prolactin were essentially unchanged or decreased during treatment. In general, akathisia and extrapyramidal symptoms (EPS) improved or were unchanged during treatment. There was no signal of worsening of efficacy based on changes from baseline in the Positive and Negative Syndrome Scale-Total.Discussion/ConclusionThis study further supports the long-term safety and tolerability of iloperidone for the treatment of schizophrenia, including iloperidone's favorable effect on metabolic laboratory parameters and low propensity to cause akathisia or EPS.

Blonanserin augmentation in patients with schizophrenia – who is benefited from blonanserin augmentation?: An open-label, prospective, multicenter study

2016 ◽  
Vol 33 (S1) ◽  
pp. s226-s226
Author(s):  
Y.S. Woo ◽  
J.E. Park ◽  
D.H. Kim ◽  
I.K. Sohn ◽  
T.Y. Hwang ◽  
...  
Keyword(s):  
Multicenter Study ◽  
Atypical Antipsychotics ◽  
Therapeutic Strategy ◽  
Psychiatric Symptoms ◽  
Open Label ◽  
Prospective Multicenter Study ◽  
Syndrome Scale ◽  
Schizophrenic Patients ◽  
Competing Interest ◽  
Negative Syndrome

IntroductionEvidences for antipsychotics augmentation for schizophrenic patients with suboptimal efficacy have been lacking although it has been widespread therapeutic strategy in clinical practice.ObjectivesThe purpose of this study was to investigate the efficacy and tolerability of blonanserin augmentation with an atypical antipsychotics (AAPs) in schizophrenic patients.MethodsA total of 100 patients with schizophrenia partially or completely unresponsive to treatment with an AAP recruited in this 12-week, open-label, non-comparative, multicenter study. Blonanserin was added to existing AAPs which were maintained during the study period. Efficacy was primarily evaluated using Positive and Negative Syndrome Scale (PANSS) at baseline, week 2, 4, 8, and 12. Predictors for PANSS response (≥ 20% reduction) was investigated.ResultsThe PANSS total score was significantly decreased at 12 weeks after blonanserin augmentation (–21.0 ± 18.1, F = 105.849, P < 0.001). Response rate on PANSS at week 12 was 51.0%. Premature discontinuation was occurred in 17 patients (17.0%) and 4 patients among them discontinued the study due to adverse events. Nine patients experienced significant weight gain during the study. Response to blonanserin augmentation was associated with severe (PANSS > 85) baseline symptom (OR = 10.298, P = 0.007) and higher dose (> 600 mg/day of chlorpromazine equivalent dose) of existing AAPs (OR = 4.594, P = 0.014).ConclusionsBlonanserin augmentation improved psychiatric symptoms of schizophrenic patients in cases of partial or non-responsive to an AAP treatment with favorable tolerability. Patients with severe symptom despite treatment with higher dose of AAP were benefited from this augmentation. These results suggested that blonanserin augmentation could be an effective strategy for specific patients with schizophrenia.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Effect of aripiprazole lauroxil in patients with acute schizophrenia as assessed by the Positive and Negative Syndrome Scale—supportive analyses from a Phase 3 study

CNS Spectrums ◽  
2017 ◽  
Vol 23 (4) ◽  
pp. 284-290 ◽  
Author(s):  
Leslie Citrome ◽  
Robert Risinger ◽  
Andrew J. Cutler ◽  
Yangchun Du ◽  
Jacqueline Zummo ◽  
...  
Keyword(s):  
Scale Score ◽  
Clinical Global Impression ◽  
Response Rates ◽  
Fixed Dose ◽  
Phase 3 ◽  
General Psychopathology ◽  
Syndrome Scale ◽  
Long Acting ◽  
Post Hoc ◽  
Negative Syndrome

ObjectiveAripiprazole lauroxil (AL) is a long-acting injectable atypical antipsychotic that was evaluated for the treatment of schizophrenia in a randomized, placebo-controlled, Phase 3 study. Here, we present exploratory analyses of supportive efficacy endpoints.MethodsPatients experiencing an acute exacerbation of schizophrenia received AL 441 mg intramuscularly (IM), AL 882 mg IM, or matching placebo IM monthly. Supportive endpoints included changes from baseline at subsequent time points in Clinical Global Impression-Severity (CGI-S) scale score; Positive and Negative Syndrome Scale (PANSS) Total score; PANSS Positive, Negative, and General Psychopathology subscale scores; PANSS Marder factors (post hoc); and PANSS responder rate. Overall response rate, based on PANSS Total score and Clinical Global Impression–Improvement (CGI-I) scale score, was also analyzed.ResultsOf 622 patients who were randomized, 596 had ≥1 post-baseline PANSS score. Patients were markedly ill at baseline (mean PANSS Total scores 92–94). Compared with placebo, CGI-S scores; PANSS Positive, Negative, and General Psychopathology subscale scores; and PANSS Marder factors were all significantly (p<0.001) improved by Day 85 with both AL doses, with significantly lower scores starting from Day 8 in most instances. Treatment response rates were significantly (p<0.001) greater with both doses of AL vs placebo.ConclusionAL demonstrated robust efficacy on CGI-S score, PANSS subscale scores, PANSS Marder factors, and response rates. Study limitations included use of a fixed dose for initial oral aripiprazole and fixed monthly AL doses without the option to individualize the oral initiation dosing or injection frequency for efficacy, tolerability, or safety.

scholarly journals Relationships between pharmacotherapy-induced metabolic changes and improved psychopathology in schizophrenia: data from a mirtazapine and first-generation antipsychotics combination trial

2013 ◽  
Vol 16 (7) ◽  
pp. 1661-1666 ◽  
Author(s):  
Viacheslav Terevnikov ◽  
Jan-Henry Stenberg ◽  
Jari Tiihonen ◽  
Evgeni Chukhin ◽  
Marina Joffe ◽  
...  
Keyword(s):  
Body Weight ◽  
Weight Gain ◽  
Side Effects ◽  
First Generation ◽  
Metabolic Effects ◽  
Open Label ◽  
Double Blind ◽  
Cholesterol Levels ◽  
Syndrome Scale ◽  
Negative Syndrome

Abstract Clinical efficacy and metabolic side-effects of antipsychotics seem to correlate with each other. In this study, interrelationship of similar metabolic effects of mirtazapine and its earlier reported desirable effects on psychopathology in first-generation antipsychotics (FGAs)-treated schizophrenia were explored. Symptomatic FGAs-treated patients with schizophrenia received a 6-wk double-blind treatment with add-on mirtazapine (n = 20) or placebo (n = 16), followed by a 6-wk open-label mirtazapine treatment. Mirtazapine (but not placebo) induced an increase in body weight and cholesterol levels. The latter was associated with a clinical improvement in all (sub)scales of the Positive and Negative Syndrome Scale [PANSS; an increase of cholesterol by 1 mmol/l predicted 7 points reduction on the PANSS total score (r = 0.85, p = 0.001)]. In schizophrenia, mirtazapine-induced weight gain and increase of total cholesterol are associated with the improved efficacy of mirtazapine-FGAs combination – a novel observation with possible clinical and theoretical implications.

Tolerability and treatment response in patients with recently diagnosed vs. chronic schizophrenia treated with paliperidone ER

2011 ◽  
Vol 26 (S2) ◽  
pp. 1502-1502
Author(s):  
A. Schreiner ◽  
D. Hoeben ◽  
C. Tessier ◽  
M. Lahaye ◽  
J. Turczynski ◽  
...  
Keyword(s):  
Treatment Response ◽  
Chronic Schizophrenia ◽  
Psychotic Symptoms ◽  
Chronic Patients ◽  
Open Label ◽  
Patient Functioning ◽  
Syndrome Scale ◽  
Negative Syndrome ◽  
Mean Time ◽  
Time Since Diagnosis

ObjectiveTo explore tolerability and treatment response in adult patients with recently diagnosed (<5 years) and chronic (>5 years) schizophrenia treated with flexible doses of paliperidone ER.MethodsInternational prospective open-label 6-month study. Endpoints were the Positive and Negative Syndrome Scale (PANSS), patient functioning and treatment-emergent adverse events (TEAEs).ResultsOf 713 recently diagnosed patients, most were male (60.9%), mean age was 33.6 ± 11.2 years and mean time since diagnosis was 2.3 ± 1.7 years. Chronic patients (n = 1003) were predominantly male (59.2%) with a mean age of 43.8 ± 11.4 and mean time since diagnosis of 15.6 ± 9.2 years. 70.4% and 71.7% of patients completed the study, respectively. Mean mode doses of paliperidone ER were similar between recently diagnosed and chronic patients (7.0 ± 2.9 mg/day and 7.2 ± 2.9 mg/day). 63.1% of recently diagnosed and 60.8% of chronic patients switching due to lack of efficacy with their previous antipsychotic had a >20% improvement in PANSS total score at endpoint, and improvement with other switching reasons was consistently numerically higher in recently diagnosed patients. The rate of patients with mild or no functional impairment increased from 17.7% to 39.8% in recently diagnosed and from 14.4% to 32.9% in chronic patients. TEAEs reported in >5% were insomnia (10.7% and 8.1%), anxiety (8.6% and 6.0%) and somnolence (5.8% and 3.4%), respectively.ConclusionThese data suggest that both recently diagnosed and chronic patients previously unsuccessfully treated with other oral antipsychotics may benefit from paliperidone ER, with a tendency for recently diagnosed patients showing some higher treatment response in psychotic symptoms and patient functioning.

Long-Term Improvement in Efficacy and Safety After Switching to Ziprasidone in Stable Outpatients with Schizophrenia

CNS Spectrums ◽  
2008 ◽  
Vol 13 (10) ◽  
pp. 898-905 ◽  
Author(s):  
George M. Simpson ◽  
Cedric J. O'Gorman ◽  
Antony Loebel ◽  
Ruoyong Yang
Keyword(s):  
Clinical Global Impression ◽  
Open Label ◽  
Conventional Antipsychotics ◽  
Syndrome Scale ◽  
Number Of Patients ◽  
Severity Scores ◽  
Intent To Treat ◽  
Study Designs ◽  
Negative Syndrome

ABSTRACTIntroduction:The long-term efficacy and tolerability of treatment with ziprasidone following a switch from prior antipsychotics was evaluated in outpatients with schizophrenia or schizoaffective disorder in three open-label, flexible-dose, 1-year extension studies.Methods:These studies enrolled completers of 6-week trials in which subjects were switched to ziprasidone from conventional antipsychotics, olanzapine, or risperidone. Identical study designs and the small number of patients entering the extensions supported pooling of the data.Results:Of 185 pooled subjects entering the extension studies, 72 completed 58 weeks of treatment. Median treatment duration was 34.6 weeks; median dose was 120 mg/day at endpoint. The intent-to-treat population showed significant improvement in Positive and Negative Syndrome Scale (PANSS) total scores (−4.3 [P≤.01]), PANSS negative scores (−2.4 [P≤.0001]), and Clinical Global Impression of severity score (−0.3 [P≤.001]). Completers showed significant improvement in mean PANSS total scores (−10.2 [P<.0001]), PANSS positive scores (−2.7 [P<.0001]), PANSS negative scores (−2.7 [P<.001]), and Clinical Global Impression of severity scores (−0.6 [P<.0001]).Conclusion:Ziprasidone was well tolerated, and patients demonstrated significant improvement in metabolic parameters and in all movement disorder assessments. Insomnia and somnolence were the only adverse events with an incidence >10% in pooled subjects. No subject had a corrected QT interval ≥500 msec.

P.3.c.008 Open-label over effectiveness of long-acting risperidone as maintenance therapy of bipolar and schizoaffective disorders

2008 ◽  
Vol 18 ◽  
pp. S409
Author(s):  
P. Castro-Loli ◽  
A. Benabarre ◽  
A. Martinez-Aran ◽  
J. Sanchez-Moreno ◽  
M. Salamero ◽  
...  
Keyword(s):  
Maintenance Therapy ◽  
Open Label ◽  
Schizoaffective Disorders ◽  
Long Acting

Tolerability and treatment response in patients with recently diagnosed vs. chronic schizophrenia treated with paliperidone ER

2011 ◽  
Vol 26 (S2) ◽  
pp. 1503-1503
Author(s):  
A. Schreiner ◽  
D. Hoeben ◽  
C. Tessier ◽  
M. Lahaye ◽  
J. Turczynski ◽  
...  
Keyword(s):  
Treatment Response ◽  
Chronic Schizophrenia ◽  
Psychotic Symptoms ◽  
Chronic Patients ◽  
Open Label ◽  
Patient Functioning ◽  
Syndrome Scale ◽  
Negative Syndrome ◽  
Mean Time ◽  
Time Since Diagnosis

ObjectiveTo explore tolerability and treatment response in adult patients with recently diagnosed (≤5 years) and chronic (>5 years) schizophrenia treated with flexible doses of paliperidone ER.MethodsInternational prospective open-label 6-month study. Endpoints were the Positive and Negative Syndrome Scale (PANSS), patient functioning and treatment-emergent adverse events (TEAEs).ResultsOf 713 recently diagnosed patients, most were male (60.9%), mean age was 33.6 ± 11.2 years and mean time since diagnosis was 2.3 ± 1.7 years. Chronic patients (n = 1003) were predominantly male (59.2%) with a mean age of 43.8 ± 11.4 and mean time since diagnosis of 15.6 ± 9.2 years. 70.4% and 71.7% of patients completed the study, respectively. Mean mode doses of paliperidone ER were similar between recently diagnosed and chronic patients (7.0 ± 2.9 mg/day and 7.2 ± 2.9 mg/day). 63.1% of recently diagnosed and 60.8% of chronic patients switching due to lack of efficacy with their previous antipsychotic had a ≥20% improvement in PANSS total score at endpoint, and improvement with other switching reasons was consistently numerically higher in recently diagnosed patients. The rate of patients with mild or no functional impairment increased from 17.7% to 39.8% in recently diagnosed and from 14.4% to 32.9% in chronic patients. TEAEs reported in ≥5% were insomnia (10.7% and 8.1%), anxiety (8.6% and 6.0%) and somnolence (5.8% and 3.4%), respectively.ConclusionThese data suggest that both recently diagnosed and chronic patients previously unsuccessfully treated with other oral antipsychotics may benefit from paliperidone ER, with a tendency for recently diagnosed patients showing some higher treatment response in psychotic symptoms and patient functioning.

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