A Trial of Sertraline in Young Children With Autism Spectrum Disorder
Model scores of the 29,894 trials active now.
Model score 12% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 11% of the time (407 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2018-07-31, after 2015-04-30 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2018-07-31. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: functiontrial isuncontrolledeffectsstable
Phrases that lowered it: aged24childrendisorderlong -
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
-
Design: parallel (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Blinding: triple (raises risk) · Design
-
Drug's FAERS reports with a death: 9.9% (lowers risk) · Drug's FDA history
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Minimum age: 2 (lowers risk) · Who can join
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Responsible party: sponsor investigator (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
-
Drug's FAERS reports in the prior 12 months: 9854 (raises risk) · Drug's FDA history
-
Disease area, psychiatry: Yes (raises risk) · Disease area
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Number of arms: 2 (raises risk) · Design
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Drug's FAERS reports before start: 63562 (raises risk) · Drug's FDA history
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Disease area, neurology: No (lowers risk) · Disease area
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Collaborators: 1 (raises risk) · Design
-
Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
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Maximum age: 6 (raises risk) · Who can join
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 2 (typical: 18)
- Maximum age
- 6 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 63562 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 9854 (typical: 412.5)
- Drug's FAERS reports marked serious
- 71.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- sertraline
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Trial of Sertraline to Treat Children With Fragile X Syndrome NCT01474746 · started 2012 · scored riskier than 13% of active trials completed
- Specifying and Treating Anxiety in Autism Research NCT03279471 · started 2017 · scored riskier than 66% of active trials completed
- A Study to Evaluate the Efficacy and Safety of AST-001 in ASD Children NCT06333964 · started 2023 · scored riskier than 15% of active trials completed
- Risperidone Treatment In Children With Autism Spectrum Disorder And High Levels Of Repetitive Behavior NCT01171937 · started 2008 · scored riskier than 40% of active trials completed
- D-Cycloserine and Social Skills Training in Autism Spectrum Disorders NCT01086475 · started 2010 · scored riskier than 27% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.