Evidence map›Paper›PMID 36632763›Full record

Trial reportNeuropsychopharmacology reports2023

A diagnostic test to examine early improvement as a predictor of later response to lurasidone in bipolar depression.

Taro Kishi, Hiroshi Nakamura, Tadafumi Kato, Nakao Iwata

Open access · goldFull text readRandomized Controlled Trial
In one paragraph

Trial report in Neuropsychopharmacology reports, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 39% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  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

4 authors at 3 institutions in 1 country.

Taro KishiDepartment of Psychiatry, Fujita Health University School of Medicine, Toyoake, Japan.ORCID 0000-0002-9237-2236
Hiroshi NakamuraMedical Affairs, Sumitomo Pharma Co., Ltd., Tokyo, Japan.
Tadafumi KatoDepartment of Psychiatry and Behavioral Science, Juntendo University Graduate School of Medicine, Tokyo, Japan.ORCID 0000-0001-7856-3952
Nakao IwataDepartment of Psychiatry, Fujita Health University School of Medicine, Toyoake, Japan.
Fujita Health University · JPJuntendo University · JPSumitomo Dainippon Pharma (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionKato et al. reported results of a 6-week, double-blind, randomized, placebo-controlled trial of lurasidone in adults with bipolar depression (BDep).

aimWe performed a post hoc analysis using data from the lurasidone trial to predict later responses from early improvements.

methodsAn early improvement was defined as a ≥20% reduction in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 2; response was defined as a ≥50% reduction in MADRS total score at Week 6; symptomatic remission were defined as a score of ≤8 on MADRS total score at Week 6.

resultsBoth sensitivity and negative predictive value (NPV) were higher for the remission outcome than for the response outcome. The interpretation of sensitivity and NPV in the lurasidone group when remission is an outcome is as follows. It means (1) that, from all remitters at Week 6, 80.6% was identified as such at Week 2 on the basis of their early improvement and (2) that a patient showing non-improvement at 2 weeks had 93.5% probability of being a non-remitters at Week 6. However, the values of specificity for both response and remission in the lurasidone group were not high.

conclusionPatients who did not show an early response at Week 2 cannot be predicted with a high probability to also show poor improvement at Week 6. In fact, some patients who did not show early response at 2 weeks might have marked improvement at 6 weeks.

Indexed as

Bipolar DisorderLurasidone HydrochlorideAdultDiagnostic Tests, RoutineHumansPredictive Value of TestsPsychiatric Status Rating ScalesLurasidone Hydrochloridebipolar depressiondiagnostic testearly improvementlurasidone

Identifiers

PMID36632763
PMCPMC10009426
OpenAlexW4315752770

What OpenQuestion holds

Textfull text, public
LicenceCC BY
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identifiers read1
Read underepoch 390

Registered trials

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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.