Neurochemical Effects of Omega-3 Fatty Acids in Adolescents at Risk for Mania
Model scores of the 29,894 trials active now.
Model score 16% for any early termination, 8% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (453 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2013-07-31, after 2009-06-30 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2013-07-31. 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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: depressivedisordermajorpatientepisode
Phrases that lowered it: participantslongfoodtermalcohol -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Sponsor's past termination rate: 12.5% (raises risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 49.9% (lowers risk) · Drug's FDA history
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Disease area, neurology: Yes (raises risk) · Disease area
-
Design: parallel (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
-
Maximum age: 21 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 26 (lowers risk) · Sponsor's track record
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Blinding: double (raises risk) · Design
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Collaborators: 2 (lowers risk) · Design
-
Minimum age: 10 (raises risk) · Who can join
-
Drug's FAERS reports before start: 3069 (raises risk) · Drug's FDA history
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Drug's FAERS reports with a death: 2.7% (lowers risk) · Drug's FDA history
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
- double (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 10 (typical: 18)
- Maximum age
- 21 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 32
- Sponsor's past termination rate
- 12.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 26 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 3069 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1370 (typical: 412.5)
- Drug's FAERS reports marked serious
- 49.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 2.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- fish, fish oil, olive oil
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
- Omega-3 Fatty Acids for Major Depressive Disorder With High Inflammation: A Personalized Approach NCT02553915 · started 2015 · scored riskier than 70% of active trials completed
- SGA-induced Metabolic Syndrome in Bipolar Youth NCT01858948 · started 2013 · scored riskier than 30% of active trials completed
- Bipolar Depression Before and After Lamotrigine Treatment NCT01042496 · started 2009 · scored riskier than 17% of active trials completed
- Antidepressant Effects of the Glycine Receptor Antagonist AV-101 (4-chlorokynurenine) in Major Depressive Disorder NCT02484456 · started 2015 · scored riskier than 38% of active trials completed
- NRX101 Glx Biomarker Validation Study NCT03402152 · started 2018 · scored riskier than 70% 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.