Multimodal Prevention of Psychosis - Investigating Efficacy of N-Acetylcysteine and Psychotherapy in CHR-Patients

NCT03149107 on ClinicalTrials.gov Phase 3 University Hospital, Bonn (academic or other) Started 2016-09-01 Terminated

Riskier than 20% of active trials

Model scores of the 29,894 trials active now.

Model score 11% for any early termination, 10% 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 (146 trials).

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

How it ended

Terminated on 2021-01-31, after 2016-09-01 start.

Reason given by the sponsor: “enrollment”

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 2021-01-31. 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

Accepts healthy volunteers: No (raises risk) · Who can join
Design: factorial (lowers risk) · Design
Sponsor's past termination rate: 10.7% (raises risk) · Sponsor's track record
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: cognitive30 dayssymptomspurpose ofthe purpose
Phrases that lowered it: asthmasubjectsmgrangethe investigator
Collaborators: 7 (lowers risk) · Design
Drug's FAERS reports marked serious: 49.5% (lowers risk) · Drug's FDA history
Primary purpose: prevention (lowers risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Drug's FAERS reports with a death: 5.7% (lowers risk) · Drug's FDA history
Sponsor type: academic or other (raises risk) · Sponsor's track record
Phase: 3 (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Blinding: triple (raises risk) · Design
Disease area, psychiatry: Yes (raises risk) · Disease area
Minimum age: 18 (raises risk) · Who can join
Number of arms: 4 (lowers risk) · Design
Disease area, neurology: No (lowers risk) · Disease area
Sponsor's past trials: 28 (lowers risk) · Sponsor's track record
Keywords listed: 1 (raises risk) · Design
Trials the sponsor started in the prior 2 years: 7 (lowers risk) · Sponsor's track record
Responsible party: principal investigator (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: 3 (typical: 2)
Number of arms: 4 (typical: 2)
Allocation: randomized
Design: factorial (typical: parallel)
Primary purpose: prevention (typical: treatment)
Blinding: triple (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: principal investigator (typical: sponsor)
Collaborators: 7 (typical: 0)
Keywords listed: 1

Who can join

Minimum age: 18
Maximum age: 40 (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 28 (typical: 32)
Sponsor's past termination rate: 10.7% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 7 (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: 30314 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 6781 (typical: 412.5)
Drug's FAERS reports marked serious: 49.5% (typical: 85.6%)
Drug's FAERS reports with a death: 5.7% (typical: 15.9%)

Disease area and drugs

Disease areas: psychiatry
Drugs matched to FDA substances: acetylcysteine

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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Relapse Prevention Study in Patients With Schizophrenia NCT01291511 · started 2011 · scored riskier than 52% 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.