Evidence map›Paper›PMID 31242884›Full record

Trial reportBMC psychiatry2019

Long-term mood/antidepressant effects of quetiapine extended-release formulation: an open-label, non-controlled extension study in Japanese patients with bipolar depression.

Shigenobu Kanba, Mitsukuni Murasaki, Tsukasa Koyama, Masahiro Takeuchi, Yuriko Shimizu, Eri Arita, Kentaro Kuroishi, Masahiro Takeuchi, Shinya Kamei

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC psychiatry, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01725308 (Phase II/III Study of FK949E), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT01725308 phase2 / phase3completednot on this map

Phase II/III Study of FK949E: Placebo-controlled, Double-blind, Parallel-group Comparative Study and Open-label, Non-controlled Extension Study in Bipolar Disorder Patients With Major Depressive Episodes

TypeinterventionalSponsorAstellas Pharma IncRan2012 to 2016Enrolled431ConditionsBipolar DisorderArmsFK949E, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
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

9 authors.

Shigenobu KanbaDepartment of Neuropsychiatry, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
Mitsukuni MurasakiInstitute of CNS Pharmacology, 3-14-20 Sagamiohno, Minami-ku, Sagamihara, Kanagawa, 252-0303, Japan.
Tsukasa KoyamaOhyachi Hospital, Clinical Research Center, 5-7-10 Ohyachi-higashi, Atsubetsu-ku, Sapporo, Hokkaido, 004-0041, Japan.
Masahiro TakeuchiDepartment of Clinical Medicine, School of Pharmacy, Kitasato University, 5-9-1 Shirokane, Minato-ku, Tokyo, 108-8641, Japan.
Yuriko ShimizuJapan/Asia Clinical Development 2, Astellas Pharma Inc.; 2-5-1 Nihonbashi-Honcho, Chuo-ku, Tokyo, 103-8411, Japan.
Eri AritaJapan/Asia Clinical Development 2, Astellas Pharma Inc.; 2-5-1 Nihonbashi-Honcho, Chuo-ku, Tokyo, 103-8411, Japan.
Kentaro KuroishiJapan-Asia Data Science, Astellas Pharma Inc, 2-5-1 Nihonbashi-Honcho, Chuo-ku, Tokyo, 103-8411, Japan.
Masahiro TakeuchiAstellas Pharma Global Development, Inc, 1 Astellas Way, Northbrook, IL, 60062, USA.
Shinya KameiJapan/Asia Clinical Development 2, Astellas Pharma Inc.; 2-5-1 Nihonbashi-Honcho, Chuo-ku, Tokyo, 103-8411, Japan. shinya.kamei@astellas.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn an 8-week, randomized, placebo-controlled, double-blind study, an extended-release formulation of quetiapine, quetiapine XR, demonstrated efficacy and safety in Japanese patients with bipolar depression. Bipolar disorder is a chronic disease requiring continuous treatment.

methodsThis was a long-term (52-week), open-label, non-controlled extension study to evaluate the long-term safety and efficacy of quetiapine XR in Japanese patients with bipolar depression who had previously completed the initial 8-week double-blind study. Efficacy was determined by the Montgomery-Åsberg Depression Rating Scale (MADRS), Hamilton Depression Scale 17-item (HAM-D

resultsThe mean (SD) MADRS total score decreased from 30.9 (6.9) at baseline to 16.1 (10.6) at week 8, and eventually to 9.1 (8.7) at week 52. The sustained efficacy of quetiapine XR treatment was also shown using HAM-D

conclusionsThe efficacy of quetiapine XR was sustained long-term and no new safety concerns were identified in Japanese patients with bipolar depression.

trial registrationClinicalTrials.gov Registration: NCT01725308. Date of registration; 12th November 2012 (retrospectively registered).

Indexed as

AdultAffectAntidepressive AgentsAntipsychotic AgentsBipolar DisorderDelayed-Action PreparationsDouble-Blind MethodFemaleHumansJapanMaleMiddle AgedPsychiatric Status Rating ScalesQuetiapine FumarateRetrospective StudiesTreatment OutcomeAntidepressive AgentsAntipsychotic AgentsDelayed-Action PreparationsQuetiapine FumarateBipolar disorderDepressionQuetiapine XR

Identifiers

PMID31242884
PMCPMC6595609

What OpenQuestion holds

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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.