Evidence map›Paper›PMID 27021967›Full record

Observational studyClinical drug investigation2016

Factors Related to Early Clinical Effects of Quetiapine Extended-Release: A Multinational, Prospective, Observational Study.

Luis Molina, Byron Recinos, Bezner Paz, Mauricio Rovelo, Fanny Elizabeth Elias Rodriguez, José Calderón, Arturo Arellano, Santiago Pomata, María Verónica Rey, Santiago Perez-Lloret

Registry-linked trialAbstract readMulticenter StudyObservational Study
PubMed Publisher
In one paragraph

Observational study in Clinical drug investigation, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02409823 (Clinical Registry of Patients Under Treatment With Atypical Antipsychotics), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 40% 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.

NCT02409823 completednot on this map

Clinical Registry of Patients Under Treatment With Atypical Antipsychotics

TypeobservationalSponsorPontifical Catholic University of ArgentinaRan2015 to 2015Enrolled665ConditionsSchizophrenia, Major Depressive Disorder, Bipolar Depressive Disorder, Parkinson's Disease With HallucinationsArmsAtypical Antipsychotics
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. 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

10 authors at 3 institutions in 3 countries.

Luis MolinaClínica de Especialidades Altamira, Managua, Nicaragua.
Byron RecinosUniversidad San Carlos de Guatemala, Guatemala, Guatemala.
Bezner PazHospital Juan de Dios de San Pedro, San Pedro, Honduras.
Mauricio RoveloInstituto de Salud Mental, Tegucigalpa, Honduras.
Fanny Elizabeth Elias RodriguezColonia Médica, San Salvador, El Salvador.
José CalderónClínica de la Conducta, Panama, Panama.
Arturo ArellanoDrugtech, Corporación Farmacéutica Recalcine, San José de Costa Rica, Costa Rica.
Santiago PomataDrugtech, Corporación Farmacéutica Recalcine, San José de Costa Rica, Costa Rica.
María Verónica ReyPharmacoepidemiology Unit, Etymos Consulting Group, Buenos Aires, Argentina.
Santiago Perez-LloretInstitute of Cardiology Research (ININCA), University of Buenos Aires, Buenos Aires, Argentina. santiagopl@conicet.gov.ar.
Universidad Metropolitana de Honduras · HNUniversity of Buenos Aires · ARUniversity of San Carlos of Guatemala · GT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesThe first weeks of treatment with antipsychotics are important for the development of their long-term efficacy. The objective of this study was to identify factors related to early clinical effects and quality of life (QoL) improvements with quetiapine extended-release (XR).

methodsSix hundred and sixty-five patients starting with quetiapine XR were followed up for 8 weeks (schizophrenia = 153, major depression = 200, bipolar depression = 252, other psychiatric conditions = 60). Clinical effects were assessed by the Clinical Global Impression of Change scale (CGI-C), QoL by the visual analog scale (VAS) of the EQ-5D (QoL-VAS), and adherence by the Moriksy scale. Adverse events were explored: movement disorders by the UKU and Simpson-Angus scales, weight gain by calibrated balances, and diurnal somnolence by the Epworth Somnolence Scale (ESS).

resultsThe mean dose of quetiapine XR during follow-up was 195.6 ± 154.8 mg/day. CGI and QoL-VAS scores improved significantly at week 8 by 2.7 ± 0.1 points and 25.1 ± 0.9 points. Adverse events were observed in 34 and 26 % of patients at weeks 4 and 8, respectively. A significant reduction in ESS score was also observed at week 8. Factors independently associated with change in QoL-VAS ≥20 points (n = 292, 43 %) were female gender, more severe disease at baseline, higher antipsychotic dose during follow-up, and improvements in somnolence. Factors independently associated with clinically significant improvement (CGI-C ≥5, n = 610, 93 %) were greater change in QoL-VAS, less frequent movement disorders at baseline, and lack of adverse events during follow-up, especially somnolence.

conclusionsResults from this real-setting, large observational study in Central America suggest that disease severity at baseline, gender, antipsychotic dose, and occurrence of adverse reactions has a significant impact on the early clinical effects of quetiapine XR. Clinicaltrials.gov registration number NCT02409823.

Indexed as

AdultAntipsychotic AgentsBipolar DisorderDelayed-Action PreparationsFemaleHumansMajor Depressive DisorderMaleMiddle AgedPatient ComplianceProspective StudiesPsychotic DisordersQuality of LifeQuetiapine FumarateSchizophreniaSleep StagesAntipsychotic AgentsDelayed-Action PreparationsQuetiapine Fumarate

Identifiers

PMID27021967
OpenAlexW2335309001

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.