Evidence map›Paper›PMID 19364290›Full record

Trial reportJournal of child and adolescent psychopharmacology2009

Activation adverse events induced by the selective serotonin reuptake inhibitor fluvoxamine in children and adolescents.

Shauna P Reinblatt, Susan DosReis, John T Walkup, Mark A Riddle

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of child and adolescent psychopharmacology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 5 pooled it
6.2field-weighted citation impact, top 4% 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

34 citing papers in PubMed, 5 syntheses or guidelines pooled it, 80 citations in OpenAlex.

  1. Pooled it
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  6. Trial
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  8. Review
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  16. Pediatric Psychopharmacology for Depressive and Anxiety Disorders.Focus (American Psychiatric Publishing) · 2022
    Review
  17. Article
  18. Article
  19. Review
  20. Associations between selective serotonin reuptake inhibitors and violent crime in adolescents, young, and older adults - a Swedish register-based study.European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology · 2020
    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 1 institution in 1 country.

Shauna P ReinblattDivision of Child and Adolescent Psychiatry, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA. sreinbl1@jhmi.edu
Susan DosReis
John T Walkup
Mark A Riddle
Johns Hopkins Medicine · US

Funding

RESEARCH TRAINING IN CHILD PSYCHOPATHOLOGY &TREATMENTT32MH020033 · NIMH · JOHNS HOPKINS UNIVERSITY · PI RIDDLE, MARK A · 1999 to 2008
$1.5M
NIMH NIH HHS T32 MH020033NIMH NIH HHS T32 MH20033
6 · The paper itself

Abstract

objectiveThe aim of this study was to examine the prevalence of activation cluster adverse events (AC-AEs) in youths treated with the selective serotonin reuptake inhibitor (SSRI) fluvoxamine for anxiety and the relationship of AC-AEs to SSRI blood levels.

methodsData from the Research Units on Pediatric Psychopharmacology (RUPP) Anxiety Study were examined for 45 youths (22 active fluvoxamine, 23 placebo) treated for Diagnostic and Statistical Manual for Mental Disorders, 4(th) edition (DSM-IV) anxiety disorders at the Johns Hopkins University site with an 8-week forced-flexible titration schedule. As part of the double-blind placebo-controlled trial, AC-AEs were recorded by clinicians at weekly patient visits. AC-AEs were defined as hyperactivity, activation, and disinhibition. Demographic characteristics, daily doses, and week-8 blood levels were examined in relation to the presence of AC-AEs. The prevalence of AC-AE and time to first event were established for those who experienced this side effect.

resultsAC-AEs were found in 10 of 22 participants (45%) receiving fluvoxamine and only 1 of 23 in the placebo group (4%). The onset of AC-AEs occurred from week 1 to week 8, with the majority occurring at or before week 4. The mean fluvoxamine blood level at week 8 in subjects with AC-AEs was higher than in subjects without AC-AEs (n = 16, t = -2.61, p = 0.04). Neither the age of the participants nor family history of bipolar or anxiety disorder differed between those who did and did not develop an AC-AE.

conclusionsAC-AEs were common side effects of fluvoxamine, often appeared during the first 8 weeks of treatment, and were associated with higher fluvoxamine blood levels. Close monitoring for AC-AEs, not only when initiating SSRI treatment but also throughout dose titration, is recommended for early identification of activation.

Indexed as

AdolescentAnxiety DisordersChildChild Behavior DisordersDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleFluvoxamineHumansMaleSelective Serotonin Reuptake InhibitorsFluvoxamineSelective Serotonin Reuptake Inhibitors

Identifiers

PMID19364290
PMCPMC2856972
OpenAlexW1974610592

What OpenQuestion holds

Textmetadata
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.