Evidence map›Paper›PMID 29185786›Full record

Trial reportJournal of child and adolescent psychopharmacology2018

Desvenlafaxine Versus Placebo in the Treatment of Children and Adolescents with Major Depressive Disorder.

Sarah Atkinson, Shannon Lubaczewski, Sara Ramaker, Richard D England, Dalia B Wajsbrot, Richat Abbas, Robert L Findling

Abstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Journal of child and adolescent psychopharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 5 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

16 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Article
  8. Review
  9. Article
  10. Psychopharmacological Approaches to a Case of Treatment Resistant Adolescent Depression.Journal of the Canadian Academy of Child and Adolescent Psychiatry = Journal de l'Academie canadienne de psychiatrie de l'enfant et de l'adolescent · 2022
    Article
  11. Efficacy and tolerability of antidepressant drugs in treatment of depression in children and adolescents: a network meta-analysis.Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences · 2022
    Article
  12. Article
  13. Review
  14. Review
  15. New Somatic Treatments for Child and Adolescent Depression.Current treatment options in psychiatry · 2019
    Article
  16. 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.

Sarah Atkinson1 Finger Lakes Clinical Research , Rochester, New York.
Shannon Lubaczewski2 Pfizer Inc , Collegeville, Pennsylvania.
Sara Ramaker2 Pfizer Inc , Collegeville, Pennsylvania.
Richard D England3 Pfizer Inc , Groton, Connecticut.
Dalia B Wajsbrot4 Pfizer Inc , New York, New York.
Richat Abbas2 Pfizer Inc , Collegeville, Pennsylvania.
Robert L Findling5 Department of Psychiatry and Behavioral Sciences, Johns Hopkins University and Kennedy Krieger Institute , Baltimore, Maryland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the short-term efficacy and safety of desvenlafaxine versus placebo in the treatment of children and adolescents with major depressive disorder (MDD).

methodsOutpatient children (7-11 years) and adolescents (12-17 years) who met DSM-IV-TR criteria for MDD and had screening and baseline Children's Depression Rating Scale-Revised (CDRS-R) total scores >40 were randomly assigned to 8 weeks of treatment with placebo, low exposure desvenlafaxine (20, 30, or 35 mg/day based on baseline weight), or higher exposure desvenlafaxine (25, 35, or 50 mg/day based on baseline weight). The primary efficacy endpoint was change from baseline in CDRS-R total score at week 8, analyzed using a mixed-effects model for repeated measures. Secondary efficacy assessments included Clinical Global Impressions-Severity and Clinical Global Impressions-Improvement scales. Safety assessments included adverse events and the Columbia-Suicide Severity Rating Scale.

resultsThe safety population included 363 patients (children, n = 109; adolescents, n = 254). No statistical separation from placebo was observed for either desvenlafaxine group for CDRS-R total score or for any secondary efficacy endpoint. At week 8, adjusted mean (standard error) changes from baseline in CDRS-R total score for the desvenlafaxine low exposure, desvenlafaxine high exposure, and placebo groups were -23.7 (1.1), -24.4 (1.1), and -22.9 (1.1), respectively. The incidence of adverse events was similar among groups.

conclusionLow and high exposure desvenlafaxine groups did not demonstrate efficacy for the treatment of MDD in children and adolescents in this double-blind, placebo-controlled trial. Desvenlafaxine (20-50 mg/day) was generally safe and well tolerated with no new safety signals identified in pediatric patients with MDD in this study.

Indexed as

AdolescentAntidepressive AgentsChildDesvenlafaxine SuccinateDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansMajor Depressive DisorderMalePsychiatric Status Rating ScalesTreatment OutcomeAntidepressive AgentsDesvenlafaxine Succinateadolescentschildrenclinical trialdesvenlafaxinemajor depressive disordertreatment efficacy

Identifiers

PMID29185786
PMCPMC5771531

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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.