Assessing Dopamine Transporter Occupancy in the Healthy Adult Brain With Toludivenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET)

NCT05905120 on ClinicalTrials.gov Phase 1 Shanghai Mental Health Center (academic or other) Started 2023-03-02 Completed

Riskier than 3% of active trials

Model scores of the 29,894 trials active now.

Model score 4% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 12% of the time (145 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2023-07-26, after 2023-03-02 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 2023-07-26. 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

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: mridiseaseimagingbrainpet
Phrases that lowered it: healthyopen labelsingledrugbody
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Sponsor's past termination rate: 4.4% (lowers risk) · Sponsor's track record
Phase: 1 (lowers risk) · Design
Disease area, psychiatry: Yes (raises risk) · Disease area
Sponsor type: academic or other (raises risk) · Sponsor's track record
Design: single group (raises risk) · Design
Trials the sponsor started in the prior 2 years: 29 (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Has a data monitoring committee: No (lowers risk) · Design
Primary purpose: treatment (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
Blinding: none (lowers risk) · Design
Maximum age: 45 (lowers risk) · Who can join
Disease area, neurology: No (lowers risk) · Disease area
Responsible party: sponsor (lowers risk) · Design

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: 1 (typical: 2)
Number of arms: 1 (typical: 2)
Allocation: not applicable (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 1 (typical: 0)
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 45 (typical: 71)
Sex: male (typical: all)
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 45 (typical: 32)
Sponsor's past termination rate: 4.4% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 29 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 0 (typical: 1)
Drug has FAERS history: No (typical: 64% yes)
Drug's FAERS reports before start: 0 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 0 (typical: 412.5)
Drug's FAERS reports marked serious: no FAERS history (typical: 85.6%)
Drug's FAERS reports with a death: no FAERS history (typical: 15.9%)

Disease area and drugs

Disease areas: psychiatry
Drugs matched to FDA substances: none matched

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

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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.