Evidence map›Paper›PMID 34342746›Full record

ArticleInternational journal of bipolar disorders2021

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

Teruhiko Higuchi, Tadafumi Kato, Mari Miyajima, Kei Watabe, Takahiro Masuda, Katsuhiko Hagi, Jun Ishigooka

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in International journal of bipolar disorders, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01986114 (A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.9field-weighted citation impact, top 27% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01986114 phase3completednot on this map

A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.

TypeinterventionalSponsorSumitomo Pharma Co., Ltd.Ran2014 to 2018Enrolled495ConditionsBipolar I DisorderArmsSM-13496
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Review
  5. Risk of Drug-induced Movement Disorders with Newer Antipsychotic Agents.Tremor and other hyperkinetic movements (New York, N.Y.) · 2022
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Teruhiko HiguchiJapan Depression Center, Tokyo, Japan.
Tadafumi KatoLaboratory for Molecular Dynamics of Mental Disorders, RIKEN Center for Brain Science, Wako, Saitama, Japan.
Mari MiyajimaSumitomo Dainippon Pharma Co., Ltd, 13-1, Kyobashi 1-Chome, Chuo-ku, Tokyo, 104-8356, Japan.
Kei WatabeSumitomo Dainippon Pharma Co., Ltd, 13-1, Kyobashi 1-Chome, Chuo-ku, Tokyo, 104-8356, Japan.
Takahiro MasudaSumitomo Dainippon Pharma Co., Ltd, 13-1, Kyobashi 1-Chome, Chuo-ku, Tokyo, 104-8356, Japan.
Katsuhiko HagiSumitomo Dainippon Pharma Co., Ltd, 13-1, Kyobashi 1-Chome, Chuo-ku, Tokyo, 104-8356, Japan. katsuhiko-hagi@ds-pharma.co.jp.ORCID http://orcid.org/0000-0003-1389-1474
Jun IshigookaInstitute of CNS Pharmacology, Tokyo, Japan.
Sumitomo Dainippon Pharma (Japan) · JPNational Center of Neurology and Psychiatry · JPRIKEN Center for Brain Science · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

methodsBipolar 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).

resultsThe 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.

conclusionsLong-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 registrationJapicCTI-132319, clinicaltrials.gov-NCT01986114.

Indexed as

Atypical antipsychoticBipolar disorderLurasidone

Identifiers

PMID34342746
PMCPMC8333182
OpenAlexW3188802644

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.