Descriptive Analyses of the Aripiprazole Arm in the Risperidone Long-acting Injectable Versus Quetiapine Relapse Prevention Trial (constatre)

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1
Author(s):  
R. de Arce ◽  
E. Eding ◽  
J. Marques-Teixeira ◽  
V. Milanova ◽  
E. Rancans ◽  
...  
Keyword(s):  
Schizoaffective Disorder ◽  
Relapse Prevention ◽  
Descriptive Analysis ◽  
Prevention Trial ◽  
Open Label ◽  
Treatment Groups ◽  
Full Remission ◽  
Kaplan Meier ◽  
Long Acting ◽  
Time To Relapse

Objective:A recent randomized, open-label, relapse prevention trial (ConstaTRE) of risperidone long-acting injectable (RLAI) versus quetiapine and the oral atypical antipsychotic aripiprazole was carried out. Here we report the descriptive analysis of the aripiprazole arm.Methods:Clinically stable adults with schizophrenia or schizoaffective disorder previously treated with oral risperidone, olanzapine, or oral conventional antipsychotic were randomized to treatment with RLAI, quetiapine, or aripiprazole (in some countries). Efficacy and tolerability were monitored for up to 24 months of treatment.Results:A total of 45 patients were treated with aripiprazole (10-30 mg/day) and 329 patients with RLAI. Relapse occurred in 27.3% aripiprazole and 16.5% RLAI-treated patients. Kaplan-Meier estimates of mean relapse-free period were 314 versus 607 days for aripiprazole and RLAI patients, respectively. Full-remission, as defined by Andreasen et al, (2005), was achieved by 34% aripiprazole and 51% RLAI patients and was maintained until the end of the trial by 30% aripiprazole and 44% RLAI patients. According to Clinical Global Impression-Severity, there were 61% aripiprazole and 62% RLAI patients moderately ill or worse at baseline, and 59% aripiprazole and 45% RLAI at endpoint, respectively. Tolerability was generally similar between aripiprazole and RLAI treatment groups. However, weight gain, extrapyramidal adverse events (AEs), and possibly prolactin-related AEs were more common with RLAI treatment. Gastrointestinal disorders were more common in aripiprazole-treated patients.Conclusions:Time-to-relapse in stable patients with schizophrenia or schizoaffective disorder tended to be longer in RLAI-treated patients when compared with aripiprazole-treated patients. both RLAI and aripiprazole treatments were generally well tolerated.

scholarly journals Long-term Remission in Schizophrenia and Schizoaffective Disorder: Results from the Risperidone Long-acting Injectable Versus Quetiapine Relapse Prevention Trial (constatre)

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1 ◽  
Author(s):  
E. Smeraldi ◽  
R. Cavallaro ◽  
V. Folnegovic Smalc ◽  
L. Bidzan ◽  
E. Ceylan ◽  
...  
Keyword(s):  
Adverse Events ◽  
Schizoaffective Disorder ◽  
Relapse Prevention ◽  
Package Insert ◽  
Prevention Trial ◽  
Treatment Groups ◽  
Conventional Antipsychotics ◽  
Full Remission ◽  
Long Acting

Objective:To report the long-term remission results from the relapse prevention trial (ConstaTRE) in stable patients treated either with risperidone long-acting injectable (RLAI) or the oral atypical antipsychotic quetiapine.Methods:Clinically stable adults with schizophrenia or schizoaffective disorder treated with oral risperidone, olanzapine, or oral conventional antipsychotics were randomized to treatment with RLAI or oral quetiapine. Dosing was according to package-insert recommendation. Efficacy and tolerability were recorded for up to 24 months of treatment. Remission was defined as achieving and maintaining mild or less symptoms of schizophrenia over a 6-month period as defined by Andreasen et al, (2005).Results:710 patients were randomized (n=355 per group) to either RLAI or quetiapine. Demographics were similar between treatment groups. Relapse occurred in 54 RLAI (16.5%) and 102 quetiapine (31.3%) patients (p< 0.001). Full remission was achieved by 51% RLAI and 39% of quetiapine-treated patients (p=0.003) and was maintained until the end of the trial by 44% of RLAI and 31% of quetiapine patients. Mean duration of full remission was 540.8±181.4 and 508.1±188.0 days for RLAI and quetiapine groups, respectively (p=0.1325). Tolerability was similar between treatment groups. Most adverse events (AEs) were transient. Six RLAI and 10 quetiapine patients discontinued study treatment due to AEs.Conclusions:Among stable patients with schizophrenia or schizoaffective disorder, remission was more likely to occur in patients switching to RLAI when compared with quetiapine. both RLAI and quetiapine treatments were well tolerated.

scholarly journals Functional Recovery in Schizophrenia and Schizoaffective Disorder: Results from the Risperidone Long-acting Injectable Versus Quetiapine Relapse Prevention Trial (constatre)

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1 ◽  
Author(s):  
F. Rouillon ◽  
L. Eriksson ◽  
B. Burba ◽  
J. Raboch ◽  
G. Kaprinis ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Functional Recovery ◽  
Schizoaffective Disorder ◽  
Relapse Prevention ◽  
Short Form ◽  
Prevention Trial ◽  
Open Label ◽  
Quality Of Life Scale ◽  
Long Acting

Objective:To report the functional recovery results from an open-label, randomized-controlled, relapse prevention trial (ConstaTRE) in stable patients with schizophrenia or schizoaffective disorder treated with risperidone long-acting injectable (RLAI) or the oral atypical antipsychotic quetiapine.Methods:Clinically stable adults with schizophrenia or schizoaffective disorder previously treated with oral risperidone, olanzapine, or oral conventional antipsychotics were randomized to treatment with either RLAI (25 mg every-two-weeks) or quetiapine (300-400 mg/day) for 24 months. Functional recovery was assessed using the Social and Occupational Functioning Assessment Scale (SOFAS) and two quality-of-life (QoL) measures (Short -Form 12 [SF-12] and Schizophrenia Quality-of-Life Scale Revision 4 [SQLS-R4]).Results:710 subjects were randomized to treatment with RLAI or quetiapine (n=355 patients/group). Baseline demographics were similar between treatment groups. Relapse occurred in 16.5% RLAI and 31.3% quetiapine patients. A total of 105 RLAI and 107 quetiapine patients dropped out of the study for other reasons than relapse, most commonly due to withdrawal of consent. A significant improvement in SOFAS, SF-12, and SQLS-R4 scores was observed from baseline to month-24 with both RLAI and quetiapine. at months 6, 12, and endpoint, SOFAS had significantly increased more for RLAI than quetiapine (p< 0.05).Conclusions:Among stable patients with schizophrenia or schizoaffective disorder, the likelihood of functional recovery appears to be higher in those switching to RLAI. Improvement in functional status and QoL from baseline was observed with both RLAI and quetiapine.

scholarly journals Relapse Prevention in Schizophrenia and Schizoaffective Disorder with Risperidone Long-Acting Injectable vs Quetiapine: Results of a Long-Term, Open-Label, Randomized Clinical Trial

2010 ◽  
Vol 35 (12) ◽  
pp. 2367-2377 ◽  
Author(s):  
Wolfgang Gaebel ◽  
Andreas Schreiner ◽  
Paul Bergmans ◽  
Rosario de Arce ◽  
Frédéric Rouillon ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Schizoaffective Disorder ◽  
Relapse Prevention ◽  
Open Label ◽  
Long Acting

Functional recovery results from the risperidone long-acting injectable versus quetiapine relapse prevention trial (ConstaTRE)

2013 ◽  
Vol 25 (5) ◽  
pp. 297-306 ◽  
Author(s):  
Frédéric Rouillon ◽  
Lars Eriksson ◽  
Benjaminas Burba ◽  
Jiri Raboch ◽  
Georgios Kaprinis ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Functional Recovery ◽  
Schizoaffective Disorder ◽  
Relapse Prevention ◽  
Short Form ◽  
Prevention Trial ◽  
Antipsychotic Treatment ◽  
Quality Of Life Scale ◽  
Long Acting

ObjectiveConstaTRE is an open-label, randomised, controlled, relapse prevention trial in patients with stable schizophrenia or schizoaffective disorder switched to risperidone long-acting injectable (RLAI) or oral quetiapine, and was designed to test the hypothesis that injectable antipsychotic treatment with risperidone would be more effective than oral therapy with quetiapine. Here we report the functional recovery results from the ConstaTRE trial.MethodsClinically stable adults previously treated with oral risperidone, olanzapine, or oral first-generation antipsychotics were randomised to RLAI or quetiapine for 24 months. Functional recovery was assessed using the Social and Occupational Functioning Assessment Scale (SOFAS) and two quality-of-life (QoL) measures [Medical Outcomes Survey Short Form-12 (SF-12) and Schizophrenia Quality-of-Life Scale Revision 4 (SQLS-R4)].ResultsA total of 666 patients were randomised and treated with RLAI (n = 329) or quetiapine (n = 337). Relapse occurred in 16.5% RLAI and 31.3% quetiapine patients. Significant improvements in SOFAS, SF-12, and SQLS-R4 scores were observed from baseline to month 24 with both RLAI and quetiapine. At months 6, and 12, and endpoint, improvement in SOFAS score was significantly greater for RLAI than quetiapine (p < 0.05).ConclusionsAmong patients with stable schizophrenia or schizoaffective disorder, the likelihood of functional recovery appears to be higher in those switching to RLAI than to quetiapine, although improvements in functional status and QoL were observed with both treatments.

Relapse Prevention in Schizophrenia and Schizoaffective Disorder with Risperidone Long-acting Injectable Versus Quetiapine: Randomized, Long-term, Open-label, Clinical Trial Results (constatre)

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1 ◽  
Author(s):  
W. Gaebel ◽  
P. Bergmans ◽  
R. de Arce ◽  
F. Rouillon ◽  
J. Cordes ◽  
...  
Keyword(s):  
Rating Scale ◽  
Treated Group ◽  
Duration Of Treatment ◽  
Open Label ◽  
Related Disorder ◽  
Kaplan Meier ◽  
Efficacy Measure ◽  
Long Acting ◽  
Time To Relapse

Objective:The ConstaTRE study was designed to compare long-term relapse in stable patients treated with risperidone long-acting injectable (RLAI) or the oral atypical antipsychotic quetiapine.Methods:This was a randomized, open-label, prospective, active-controlled, multicenter, 2-year trial in symptomatically stable patients with schizophrenia or related disorder who were switched from stable treatment with oral risperidone, olanzapine, or oral conventional antipsychotic to RLAI or quetiapine. Primary efficacy measure was time-to-relapse. Positive and Negative Syndrome Scale (PANSS) scores and safety (adverse events [AEs] and Extrapyramidal Symptom Rating Scale [ESRS]) evaluations were reported.Results:710 patients were randomized (n=355 per group), with 666 patients (n=329 RLAI and n=337 quetiapine) being evaluable. Mean doses were 32.8±8.0 mg every-two-weeks for RLAI and 396.8±141.9 mg/day for quetiapine. Kaplan-Meier analysis indicated a significantly longer relapse-free period with RLAI treatment (log rank: p< 0.0001). Relapse occurred in 16.5% of RLAI and 31.3% of quetiapine patients. Mean duration of treatment was 483.8±277.8 and 400.7±290.6 days for RLAI and quetiapine, respectively. Total PANSS scores improved significantly from baseline to endpoint for the RLAI-treated group (p< 0.001). the endpoint difference favors RLAI over quetiapine (p< 0.001). Treatment-emergent AEs were similar between groups. ESRS total scores decreased for both groups. Possibly prolactin-related AEs occurred more often with RLAI than quetiapine (4.6% versus 1.5%, respectively). Somnolence was reported less often with RLAI than quetiapine (1.8% versus 11.3%, respectively).Conclusions:Time-to-relapse was significantly longer and relapse rates were significantly lower for RLAI compared with quetiapine. both treatments were well tolerated.

scholarly journals Long-term remission in schizophrenia and schizoaffective disorder: results from the risperidone long-acting injectable versus quetiapine relapse prevention trial (ConstaTRE)

2013 ◽  
Vol 3 (4) ◽  
pp. 191-199 ◽  
Author(s):  
Enrico Smeraldi ◽  
Roberto Cavallaro ◽  
Vera Folnegović-Šmalc ◽  
Leszek Bidzan ◽  
Mehmet Emin Ceylan ◽  
...  
Keyword(s):  
Schizoaffective Disorder ◽  
Relapse Prevention ◽  
Prevention Trial ◽  
Long Acting

Long-term cariprazine treatment for the prevention of relapse in patients with schizophrenia: A randomized, double-blind, placebo-controlled trial

2020 ◽  
pp. 27-37
Author(s):  
Suresh Durgam ◽  
Willie Earley ◽  
Rui Li ◽  
Dayong Li ◽  
Kaifeng Lu ◽  
...  
Keyword(s):  
Safety Profile ◽  
Relapse Prevention ◽  
Controlled Trial ◽  
Fixed Dose ◽  
Open Label ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Randomized Controlled ◽  
Time To Relapse

Cariprazine, a dopamine D3/D2 receptor partial agonist with preference for D3 receptors, has demonstrated efficacy in randomized controlled trials in schizophrenia. This multinational, randomized, double-blind, placebo-controlled, parallel-group study evaluated the efficacy, safety, and tolerability of cariprazine for relapse prevention in adults with schizophrenia; total study duration was up to 97 weeks. Schizophrenia symptoms were treated/stabilized with cariprazine 3—9 mg/d during 20-week open-label treatment consisting of an 8-week, flexible-dose run-in phase and a 12-week fixed-dose stabilization phase. Stable patients who completed open-label treatment could be randomized to continued cariprazine (3, 6, or 9 mg/d) or placebo for double-blind treatment (up to 72 weeks). The primary efficacy parameter was time to relapse (worsening of symptom scores, psychiatric hospitalization, aggressive/violent behavior, or suicidal risk); clinical measures were implemented to ensure safety in case of impending relapse. A total of 264/765 patients completed open-label treatment; 200 eligible patients were randomized to double-blind placebo (n = 99) or cariprazine (n = 101). Time to relapse was significantly longer in cariprazine — versus placebo-treated patients (P = .0010, log-rank test). Relapse occurred in 24.8% of cariprazine- and 47.5% of placebo-treated patients (hazard ratio [95% CI] = 0.45 [0.28, 0.73]). Akathisia (19.2%), insomnia (14.4%), and headache (12.0%) were reported in ≥ 10% of patients during open-label treatment; there were no cariprazine adverse events ≥ 10% during double-blind treatment. Long-term cariprazine treatment was significantly more effective than placebo for relapse prevention in patients with schizophrenia. The long-term safety profile in this study was consistent with the safety profile observed in previous cariprazine clinical trials. ClincalTrials.gov identifier: NCT01412060. Key words: schizophrenia; cariprazine; long-term treatment; relapse prevention; randomized controlled trial; oral antipsychotics

scholarly journals First-generation versus second-generation long-acting injectable antipsychotic drugs and time to relapse

2018 ◽  
Vol 8 (12) ◽  
pp. 333-336 ◽  
Author(s):  
James M. Stone ◽  
Simon Roux ◽  
David Taylor ◽  
Paul D. Morrison
Keyword(s):  
First Generation ◽  
Antipsychotic Drugs ◽  
Second Generation ◽  
Patient Acceptability ◽  
Inpatient Ward ◽  
Medication Discontinuation ◽  
Kaplan Meier ◽  
The Difference ◽  
Long Acting ◽  
Time To Relapse

Background: The development of long-acting injectable formulations (LAIs) of second-generation antipsychotic drugs (SGAs) has been suggested as having advantage over first-generation antipsychotic (FGA) LAIs. In this study, we investigated the hypothesis that there was a longer time to relapse in patients with schizophrenia started on SGA LAI versus FGA LAI. Methods: Patients with a diagnosis of schizophrenia or schizoaffective disorder who were started on an SGA LAI while on an inpatient ward were identified through searching of the anonymised historical medical records at the South London and Maudsley NHS Foundation Trust. Patients starting FGA LAIs matched for diagnosis, age and date of hospital admission were identified. Time to readmission, discontinuation of LAI or death were identified. Kaplan–Meier plots were generated for each group, and the difference between groups analysed using log-rank methods. Results: There were 157 patients identified in each group. There was no difference in time to readmission, medication discontinuation or death in patients on SGA LAI versus FGA LAI. Conclusions: We found no evidence of advantage in terms of maintaining response in SGA LAI versus FGA LAI. Prescriber choice should be guided by other factors such as side-effect profile, patient acceptability and price.

Sign in / Sign up

Export Citation Format

Share Document