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

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.

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Long-term safety and seizure outcome in Japanese patients with Lennox–Gastaut syndrome receiving adjunctive rufinamide therapy: An open-label study following a randomized clinical trial

Epilepsy Research ◽

10.1016/j.eplepsyres.2016.01.002 ◽

2016 ◽

Vol 121 ◽

pp. 1-7 ◽

Cited By ~ 13

Author(s):

Yoko Ohtsuka ◽

Harumi Yoshinaga ◽

Yukiyoshi Shirasaka ◽

Rumiko Takayama ◽

Hiroki Takano ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Japanese Patients ◽

Seizure Outcome ◽

Open Label ◽

Open Label Study ◽

Label Study

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

European Psychiatry ◽

10.1016/s0924-9338(09)71254-4 ◽

2009 ◽

Vol 24 (S1) ◽

pp. 1-1 ◽

Cited By ~ 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.

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Long‐term efficacy and safety of erenumab in migraine prevention: results from a 5‐year, open‐label treatment phase of a randomized clinical trial

European Journal of Neurology ◽

10.1111/ene.14715 ◽

2021 ◽

Author(s):

Messoud Ashina ◽

Peter J Goadsby ◽

Uwe Reuter ◽

Stephen Silberstein ◽

David W Dodick ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Treatment Phase ◽

Migraine Prevention ◽

Efficacy And Safety ◽

Open Label ◽

Term Efficacy

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VITRECTOMY WITH SILICONE OIL OR LONG-ACTING GAS IN EYES WITH GIANT RETINAL TEARS: Long-term Follow-up of a Randomized Clinical Trial

Retina ◽

10.1097/00006982-199903000-00002 ◽

1999 ◽

Vol 19 (3) ◽

pp. 188-192 ◽

Cited By ~ 4

Author(s):

COŞAR BATMAN ◽

OSMAN ÇEKiÇ

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Silicone Oil ◽

Retinal Tears ◽

Long Term Follow Up ◽

Long Acting

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

European Psychiatry ◽

10.1016/s0924-9338(09)71256-8 ◽

2009 ◽

Vol 24 (S1) ◽

pp. 1-1 ◽

Cited By ~ 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.

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