Lurasidone in the Long-Term Treatment of Bipolar I Depression: A 28-week Open Label Extension Study

Ishigooka, Jun; Kato, Takeshi; Miyajima, Masayasu; Watabe, Kei; Masuda, Takahiro; Hagi, Katsuhiko; Higuchi, Tetsuya

doi:10.1016/j.jad.2020.12.005

Cited by 7 publications

(12 citation statements)

References 25 publications

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“…In the first study (Ketter et al 2016), 16.6% of the sample had an Asian background. In the second study, 28.3% of patients were Japanese (Ishigooka et al 2021).…”

Section: Introductionmentioning

confidence: 89%

“…In one extension study, 24 weeks of open-label lurasidone treatment was well tolerated with minimal effects on weight and metabolic parameters and continued improvements in depressive symptoms (Ketter et al 2016). A second 28 week open-label extension study of lurasidone monotherapy also found minimal changes in body weight and metabolic parameters and further improvements in depressive symptoms (Ishigooka et al 2021). In the first study (Ketter et al 2016), 16.6% of the sample had an Asian background.…”

Section: Introductionmentioning

confidence: 99%

“…Despite the three short-term positive trials of lurasidone as a monotherapy or adjunctive therapy for bipolar depression (Loebel et al 2014a, b;Kato et al 2020), and the two extension trials of 24 and 28 weeks (Ketter et al 2016;Ishigooka et al 2021), the generalizability of the results to a Japanese population and to bipolar patients with a most recent manic, hypomanic, or mixed episode is uncertain. In addition, safety and symptom changes over the course of longer term (beyond 28 weeks) lurasidone treatment for bipolar disorder has not been reported.…”

Section: Introductionmentioning

confidence: 99%

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Lurasidone in the long-term treatment of Japanese patients with bipolar I disorder: a 52 week open label study

Higuchi

Kato

Miyajima

et al. 2021

Int J Bipolar Disord

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Background The current study evaluated the long-term (52 week) safety and impact on symptom measures of lurasidone (with or without lithium or valproate) for the treatment of bipolar I disorder in Japanese patients. Methods Bipolar patients for this open-label flexibly dosed lurasidone (20–120 mg/day) study were recruited from those with a recent/current depressive episode who completed an initial 6 week, double-blind, placebo-controlled, lurasidone study (depressed group), and those with a recent/current manic, hypomanic, or mixed episode (non-depressed group) who agreed to enroll directly into the long-term study. Measures of adverse events and safety included treatment-emergent adverse events, vital signs, body weight, ECG, laboratory tests, and measures of suicidality and extrapyramidal symptoms. Symptom measures included Montgomery Åsberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS). Results The most common adverse events associated with lurasidone were akathisia (30.7%), nasopharyngitis (26.6%), nausea (12.1%), and somnolence (12.1%). Minimal changes in lipids and measures of glycemic control occurred. Mean change in body weight was + 1.0 kg in the non-depressed group and − 0.8 kg in the depressed group. MADRS total scores declined by a mean (SD) of 2.0 (14.7) points from long-term baseline to endpoint in the depressed group who had received placebo in the prior 6 week trial. The depressed group that had received lurasidone during the prior 6 week study maintained their depressive symptom improvements. For the non-depressed group, YMRS total scores decreased over time. Limitations No control group was included, treatment was open-label, and 49.7% of patients completed the 52 week study. Conclusions Long-term treatment with lurasidone 20–120 mg/day for Japanese patients with bipolar disorder maintained improvements in depressive symptoms for depressed patients who were treated in a prior 6 week trial and led to improvements in manic symptoms among a newly recruited subgroup of patients with a recent/current manic, hypomanic, or mixed episode. Few changes in weight or metabolic parameters were evident. Clinical trial registration: JapicCTI-132319, clinicaltrials.gov—NCT01986114.

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“…In the first study (Ketter et al 2016), 16.6% of the sample had an Asian background. In the second study, 28.3% of patients were Japanese (Ishigooka et al 2021).…”

Section: Introductionmentioning

confidence: 89%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Lurasidone in the long-term treatment of Japanese patients with bipolar I disorder: a 52 week open label study

Higuchi

Kato

Miyajima

et al. 2021

Int J Bipolar Disord

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“…A 24-week open-label extension trial (n = 813) for lurasidone’s adjunctive use in bipolar depression showed rates of overall DIMD and akathisia as high as 10.7% and 8.1%, respectively, with these AEs found more commonly in adjunctive therapy rather than monotherapy arms [ 69 ]. Another 28-week open label extension trial (n = 413) showed akathisia and parkinsonism in 18.2% and 7.3%, respectively [ 70 ]. Discontinuation rate of lurasidone due to akathisia was less than 3% in these studies [ 69 70 ].…”

Section: Incidence Of Dimd With Novel Antipsychoticsmentioning

confidence: 99%

Risk of Drug-induced Movement Disorders with Newer Antipsychotic Agents

Kannarkat

Caroff

Morley

2022

Tremor and Other Hyperkinetic Movements

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Background: The last decade has seen development of numerous novel antipsychotic drugs with unique mechanisms including long-acting formulations for clinical use. A comparative assessment of these new drugs with each other and previous antipsychotics have not been performed with regards to risk for drug-induced movement disorders (DIMD). Methods: Medline was searched from January 2010 to February 2022 for primary research articles and review articles in English using the search terms “extrapyramidal” and “tardive” with individual drug names of novel antipsychotics. Results: We identified articles describing the risk of DIMD with 6 novel antipsychotics, 4 novel formulations, and 3 experimental antipsychotics. Both short- and long-term data generally showed comparable to lower risk of DIMD with novel antipsychotics and recent long-acting formulations compared to previously marketed antipsychotics. Discussion: Several novel antipsychotics, particularly lumateperone and pimavanserin, show promise in being able to treat psychosis while reducing the risk of DIMD. Long-acting paliperidone may reduce risk of DIMD while other long-acting injectable formulations of SGA have similar risk of DIMD compared to oral formulations. New drug targets for treating psychosis without dopamine blockade also show promise.

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“…К концу 28-й недели общий средний балл по шкале MADRS снизился как в группе, ранее принимавшей луразидон в течениее 6 недель (на 8,9 баллов), так и в группе, ранее принимавшей плацебо (на 11,3 балла). Среди побочных эффектов отмечались акатизия, головная боль и сонливость [13].…”

Section: применение атипичных антипсихотиков при биполярной депрессии луразидонunclassified

The use of atypical antipsychotics in the therapy of depressive episodes in patients with bipolar disorder

Streltsov

2021

Med. vestn. Ûga Ross.

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This literature review addresses the effi cacy and safety of atypical antipsychotics in patients with bipolar depression. Th e results of randomized studies and systematic meta-analyses of recent years were revised in detail. The effi cacy of the drug intake was reviewed for the following key research points: Clinical General Impression of Condition Severity Scale (CGI-S) and Montgomery-Asberg Depression Rating Scale (MADRS). A systematic literature search was carried out using Scopus, Web of Science, MedLine, elibrary, and other databases.

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Lurasidone in the Long-Term Treatment of Bipolar I Depression: A 28-week Open Label Extension Study

Cited by 7 publications

References 25 publications

Lurasidone in the long-term treatment of Japanese patients with bipolar I disorder: a 52 week open label study

Lurasidone in the long-term treatment of Japanese patients with bipolar I disorder: a 52 week open label study

Risk of Drug-induced Movement Disorders with Newer Antipsychotic Agents

The use of atypical antipsychotics in the therapy of depressive episodes in patients with bipolar disorder

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