Evidence map›Paper›PMID 26645209›Full record

Trial reportJournal of psychopharmacology (Oxford, England)2016

A double-blind, placebo-controlled, randomized withdrawal study of lurasidone for the maintenance of efficacy in patients with schizophrenia.

Rajiv Tandon, Josephine Cucchiaro, Debra Phillips, David Hernandez, Yongcai Mao, Andrei Pikalov, Antony Loebel

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of psychopharmacology (Oxford, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 3 pooled it
–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.

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

33 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Maintenance treatment with antipsychotic drugs for schizophrenia.The Cochrane database of systematic reviews · 2020
    Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Review
  18. Article
  19. Article
  20. 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

7 authors.

Rajiv TandonUniversity of Florida College of Medicine, Gainesville, FL, USA tandon@ufl.edu.
Josephine CucchiaroSunovion Pharmaceuticals Inc., Fort Lee and Marlborough, NJ, USA.
Debra PhillipsSunovion Pharmaceuticals Inc., Fort Lee and Marlborough, NJ, USA.
David HernandezSunovion Pharmaceuticals Inc., Fort Lee and Marlborough, NJ, USA.
Yongcai MaoSunovion Pharmaceuticals Inc., Fort Lee and Marlborough, NJ, USA.
Andrei PikalovSunovion Pharmaceuticals Inc., Fort Lee and Marlborough, NJ, USA.
Antony LoebelSunovion Pharmaceuticals Inc., Fort Lee and Marlborough, NJ, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the effectiveness of lurasidone as maintenance treatment for schizophrenia.

methodAdults experiencing an acute exacerbation of schizophrenia initially received 12-24 weeks of open-label treatment with lurasidone (40-80 mg/d, flexibly dosed). Patients who maintained clinical stability for ⩾12 weeks were randomized in double-blind fashion to placebo or lurasidone (40-80 mg/d, flexibly dosed) for an additional 28-week treatment period. The primary efficacy endpoint was time to relapse (based on Kaplan-Meier survival analysis).

resultsA total of 676 patients enrolled in the open-label phase; 285 met protocol-specified stabilization criteria and were randomized to lurasidone (N=144) or placebo (N=141). During the open-label phase, mean Positive and Negative Syndrome Scale total score decreased from 90.1 to 54.4 in patients who met clinical stability criteria and were randomized. In the double-blind phase, lurasidone significantly delayed time to relapse compared with placebo (log-rank test, p=0.039), reflecting a 33.7% reduction in risk of relapse (Cox hazard ratio (95% confidence interval), 0.663 (0.447-0.983); p=0.041). Probability of relapse at the double-blind week 28 endpoint (based on Kaplan-Meier analysis) was 42.2% in the lurasidone group and 51.2% in the placebo group. Minimal changes in weight, lipid, glucose, and prolactin were observed throughout the study.

conclusionsThis multicenter, placebo-controlled, randomized withdrawal study demonstrated the efficacy of lurasidone for the maintenance treatment of patients with schizophrenia.

Indexed as

AdultAntipsychotic AgentsDouble-Blind MethodFemaleHumansLurasidone HydrochlorideMaleMiddle AgedProportional Hazards ModelsPsychiatric Status Rating ScalesRecurrenceSchizophreniaTime FactorsTreatment OutcomeAntipsychotic AgentsLurasidone Hydrochlorideantipsychotic agentsdrug therapyLurasidonemaintenance treatmentrelapse preventionschizophrenia

Identifiers

PMID26645209
PMCPMC4717319

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.