Evidence map›Paper›PMID 19671933›Full record

SynthesisBMJ (Clinical research ed.)2009

Risk of suicidality in clinical trials of antidepressants in adults: analysis of proprietary data submitted to US Food and Drug Administration.

Marc Stone, Thomas Laughren, M Lisa Jones, Mark Levenson, P Chris Holland, Alice Hughes, Tarek A Hammad, Robert Temple, George Rochester

Open access · hybridAbstract readMeta-AnalysisReview
In one paragraph

Synthesis in BMJ (Clinical research ed.), 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 203 papers, 21 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
203citing papers in PubMed, 21 pooled it
37.8field-weighted citation impact, top 1% 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

203 citing papers in PubMed, 21 syntheses or guidelines pooled it, 601 citations in OpenAlex.

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  7. Pharmacological interventions for self-harm in adults.The Cochrane database of systematic reviews · 2021
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  10. Diving and antidepressants.Diving and hyperbaric medicine · 2017
    Guideline
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  13. Can systematic reviews contribute to regulatory decisions?European journal of clinical pharmacology · 2017
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143 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Marc StoneCenter for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, USA. marc.stone@fda.hhs.gov
Thomas Laughren
M Lisa Jones
Mark Levenson
P Chris Holland
Alice Hughes
Tarek A Hammad
Robert Temple
George Rochester
Center for Drug Evaluation and Research · USUnited States Food and Drug Administration · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo examine the risk of suicidal behaviour within clinical trials of antidepressants in adults.

designMeta-analysis of 372 double blind randomised placebo controlled trials.

settingDrug development programmes for any indication in adults.

participants99 231 adults assigned to antidepressants or placebo. Median age was 42 and 63.1% were women. Indications for treatment were major depression (45.6%), other depression (4.6%), other psychiatric disorders (27.6%), and non-psychiatric disorders (22.2%).

main outcome measuresSuicidal behaviour (completed suicide, attempted suicide, or preparatory acts) and ideation.

resultsFor participants with non-psychiatric indications, suicidal behaviour and ideation were extremely rare. For those with psychiatric indications, risk was associated with age. For suicidal behaviour or ideation and for suicidal behaviour only, the respective odds ratios were 1.62 (95% confidence interval 0.97 to 2.71) and 2.30 (1.04 to 5.09) for participants aged <25, 0.79 (0.64 to 0.98) and 0.87 (0.58 to 1.29) for those aged 25-64, and 0.37 (0.18 to 0.76) and 0.06 (0.01 to 0.58) for those aged >or=65. When age was modelled as a continuous variable, the odds ratio for suicidal behaviour or ideation declined at a rate of 2.6% per year of age (-3.9% to -1.3%, P=0.0001) and the odds ratio for suicidal behaviour declined at a rate of 4.6% per year of age (-7.4% to -1.8%, P=0.001).

conclusionsRisk of suicidality associated with use of antidepressants is strongly age dependent. Compared with placebo, the increased risk for suicidality and suicidal behaviour among adults under 25 approaches that seen in children and adolescents. The net effect seems to be neutral on suicidal behaviour but possibly protective for suicidal ideation in adults aged 25-64 and to reduce the risk of both suicidality and suicidal behaviour in those aged >or=65.

Indexed as

AdolescentAdultAgedAged, 80 and overAntidepressive AgentsDepressive DisorderDouble-Blind MethodFemaleHumansMaleMiddle AgedRandomized Controlled Trials as TopicRisk FactorsSuicideSuicide, AttemptedUnited StatesAntidepressive Agents

Identifiers

PMID19671933
PMCPMC2725270
OpenAlexW2164816593

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.