A Study of JNJ-55308942 in the Treatment of Bipolar Depression

NCT05328297 on ClinicalTrials.gov Phase 2 Janssen Pharmaceutica N.V., Belgium (industry) Started 2022-06-03 Completed

Riskier than 40% of active trials

Model scores of the 29,894 trials active now.

Model score 15% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (269 trials).

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

How it ended

Completed on 2024-05-17, after 2022-06-03 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 2024-05-17. 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

Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 10.5% (raises risk) · Sponsor's track record
Phase: 2 (raises risk) · Design
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: brainplacebopregnancy testhave negativerandomization
Phrases that lowered it: participantparticipantsfirst dosemoderatethe efficacy
Design: parallel (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Has a data monitoring committee: No (lowers risk) · Design
Blinding: double (raises risk) · Design
Disease area, psychiatry: Yes (raises risk) · Disease area
Primary purpose: treatment (raises risk) · Design
Sponsor's past trials: 38 (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 4 (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
Disease area, neurology: No (lowers risk) · Disease area

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: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 64 (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 38 (typical: 32)
Sponsor's past termination rate: 10.5% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 4 (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

A Safety and Efficacy Study of JNJ26489112 in Patients With Treatment-Resistant Major Depressive Disorder NCT01114698 · started 2011 · scored riskier than 51% of active trials terminated
A Study to Explore the Efficacy of JNJ-89495120 in the Treatment of Major Depressive Disorder NCT06785012 · started 2024 · scored riskier than 54% of active trials completed
A Study to Investigate the Safety, Tolerability, and Pharmacodynamics of JNJ-54175446 in Participants With Major Depressive Disorder NCT02902601 · started 2016 · scored riskier than 19% of active trials completed
To Evaluate the Effects of NMRA-335140 on Symptoms of Major Depression in Participants With Bipolar II Disorder. NCT06429722 · started 2024 · scored riskier than 52% of active trials completed
A Study to Investigate the Antidepressant Mechanism-of-action of JNJ-42847922 in Participants With Major Depressive Disorder NCT03374475 · started 2018 · scored riskier than 36% 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.