Safety and efficacy from a 6‐week double‐blind study and a 52‐week open‐label extension of aripiprazole in adolescents with schizophrenia in Japan

Matsumoto, Hideo; Ishigooka, Jun; Ono, Hiroaki; Tadori, Yoshihiro

doi:10.1111/pcn.12681

Cited by 9 publications

(6 citation statements)

References 19 publications

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“…It is possible extended trials of oral Aripiprazole therapy could decrease the chance of non-adherence with the depot formula, as our study showed that those patients who stopped Aripiprazole Depot had taken Aripiprazole PO prior to Depot for a shorter time than those continuing. This might be because side effects continued to emerge weeks after the start of the treatment, [31][32][33] and as indicated by the present findings, patients experiencing side effects after receiving oral Aripiprazole are more likely to suffer from side effects with Aripiprazole Depot.…”

Section: Discussionmentioning

confidence: 67%

Safety and effectiveness of long-acting injectable Aripiprazole in daily practice: A naturalistic retrospective study

Dawood

Smith

Nadeem

et al. 2020

The European Journal of Psychiatry

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Background and objectives: It was postulated that Aripiprazole may cause impulse-control problems.Therefore, real-world data on the effects and side effects of Aripiprazole 400mg depot are needed to review the utility, safety and the clinical effectiveness of Aripriprazole 400mg depot and highlight the occurrence of adverse effects including impulsivity in a naturalistic treatment settings. Methods: A non-interventional, retrospective study was conducted to examine the electronic records of all patients who were receiving or had received Aripiprazole Lauroxil in South West London before May 2017. Disorder symptoms and side effects were compared between pre-and post-Aripiprazole PO and Aripiprazole Depot treatments. Results: Data were considered for 57 patients who switched to Aripiprazole depot due to non-compliance and/or side effects. Most were suffering from chronic schizophrenia (75.4%) and half (50.9%) had comorbid alcohol and/or illicit drug use. Oral Aripiprazole was effective in improving hallucinations, delusions and depressive symptoms (P<0.022); these benefits were maintained or enhanced further with Aripiprazole Depot. Proportions of patients experiencing sexual disinhibition, aggression and deliberate self-ham decreased significantly (P<0.003) after starting oral Aripiprazole with no further change after Aripiprazole Depot. By study end, a quarter of patients had stopped taking Aripiprazole Depot due to ineffectiveness, side effects or patient request. Conclusion: Aripriprazole Lauroxil 400mg depot was safe, effective and well tolerated. Side effects manifestations should prompt full evaluations and dose reduction should be considered.

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Section: Discussionmentioning

confidence: 67%

Safety and effectiveness of long-acting injectable Aripiprazole in daily practice: A naturalistic retrospective study

Dawood

Smith

Nadeem

et al. 2020

The European Journal of Psychiatry

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“…Three of the four studies with mortality rates of 0 were randomized controlled trials conducted in the presence of a physician, with the follow-up periods ≤ 2 years. 32 - 34 In two studies 33 , 34 the sample consisted of adolescents or recently hospitalized individuals. Thus, age of onset, disease severity, better compliance, and an insufficient period of time to observe deaths might explain this situation.…”

Section: Discussionmentioning

confidence: 99%

Long-term effects of antipsychotics on mortality in patients with schizophrenia: a systematic review and meta-analysis

Jia¹,

Li²,

Li³

et al. 2022

Brazilian Journal of Psychiatry

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Objective: To gather current evidence on the impact of antipsychotics on long-term mortality in patients with schizophrenia. Methods: We systematically searched for articles in Embase, PubMed, and PsycINFO reporting the long-term mortality (follow-up > 1 year) of patients with schizophrenia who were using any antipsychotics. We then conducted multiple meta-analyses to determine differences in long-term mortality between different types of antipsychotics. Results: We identified 45 articles that provided unadjusted long-term mortality rates, including 46,171 deaths during 2,394,911 person-years. The pooled mortality rate was 9.9 (95%CI = 7.4-12.7) per 1,000 person-years. The unadjusted crude mortality rate of antipsychotic drug users was lower than that of non-users (risk ratio [RR] = 0.546, 95%CI = 0.480-0.621), first-generation antipsychotics caused higher all-cause mortality than second-generation antipsychotics (RR = 1.485, 95%CI = 1.361-1.620), and polypharmacy had better effects than monotherapy on long-term mortality (RR = 0.796, 95%CI = 0.689-0.921). As for the causes of death, heart disease and cardiovascular disease ranked highest among cause-specific mortality (5.6 per 1,000 person-years). Conclusion: Since antipsychotics had a beneficial effect on long-term mortality in schizophrenia, greater precaution should be taken with patients who do not take them. However, since disease severity, comorbidities, and other confounding factors cannot be fully controlled, further research and verification are needed.

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“…Aripiprazole showed efficacy in the treatment of adolescents with acute schizophrenia in several double-blind placebo-controlled studies, [8][9][10] leading to its approval for 13-to 17-year-old adolescents with schizophrenia. However, the LAI formulation still remains offlabel in youths.…”

Section: Introductionmentioning

confidence: 99%

“…This start regimen has the clear advantage of not requiring oral aripiprazole supplementation, eventually bypassing the potential issue of lack of adherence to oral treatment. Aripiprazole showed efficacy in the treatment of adolescents with acute schizophrenia in several double‐blind placebo‐controlled studies, 8 , 9 , 10 leading to its approval for 13‐ to 17‐year‐old adolescents with schizophrenia. However, the LAI formulation still remains off‐label in youths.…”

Section: Introductionmentioning

confidence: 99%

Aripiprazole LAI two‐injection start in a 16 year‐old adolescent with schizophrenia

Salvi

Appignanesi

Marpepa

et al. 2022

Neuropsychopharm Rep

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Background: Aripiprazole long-acting injection (LAI) is approved for the treatment of schizophrenia in adults. Recently, Europe and Canada approved the use of the twoinjection start regimen: two separate injections of 400-mg long-acting aripiprazole along with a single 20-mg dose of oral aripiprazole. Aripiprazole showed efficacy in the treatment of adolescents with acute schizophrenia in several controlled trials, leading to its approval for 13-to 17-year-old adolescents with schizophrenia by the EMA. However, the LAI formulation still remains off-label in adolescents. Case presentation:The patient was admitted to the General Psychiatry inpatient unit with a Positive and Negative Syndrome Scale (PANSS) total score of 136 and the Clinical Global Impression (CGI) score of 7. Aripiprazole was started and up-titrated to 30 mg/d. After 3 weeks, the positive symptoms were significantly reduced; however, he still showed prominent negative symptoms. Clozapine 100 mg/d was added, and in the following 2 weeks, the patient appeared slightly more communicative and generally more aware of himself and the others. The PANSS total score decreased to 81. Due to poor insight, the patient was at-risk not to take medications upon returning home; therefore, aripiprazole LAI was proposed. Since he urged to be discharged from the hospital, we opted for the two-injection start. The medication was optimally tolerated, with no evidence of akathisia or other side effects. One month later, global functioning and illness insight improved; Positive and Negative Syndrome Scale score was 43 and CGI score 2.Conclusions: Aripiprazole LAI showed good efficacy and tolerability in an adolescent with schizophrenia. The two-injection start regimen was a safe and effective option.

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Safety and efficacy from a 6‐week double‐blind study and a 52‐week open‐label extension of aripiprazole in adolescents with schizophrenia in Japan

Abstract: These study results suggest that aripiprazole would be safe and well tolerated in both short- and long-term treatment for adolescents with SCZ in Japan.

Cited by 9 publications

References 19 publications

Safety and effectiveness of long-acting injectable Aripiprazole in daily practice: A naturalistic retrospective study

Safety and effectiveness of long-acting injectable Aripiprazole in daily practice: A naturalistic retrospective study

Long-term effects of antipsychotics on mortality in patients with schizophrenia: a systematic review and meta-analysis

Aripiprazole LAI two‐injection start in a 16 year‐old adolescent with schizophrenia

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