The Quietude Study: Quetiapine Use for Agitated Depression

NCT01363310 on ClinicalTrials.gov Phase 3 Physicians Research And Education Network (academic or other) Started 2010-10-31 Terminated

Riskier than 39% of active trials

Model scores of the 29,894 trials active now.

Model score 15% for any early termination, 6% 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 (741 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

Terminated on 2013-02-28, after 2010-10-31 start.

Reason given by the sponsor: “business”

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 2013-02-28. 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) (raises risk) · Wording Phrases that raised it: patientdiagnosisdefinedbaselinescore
Phrases that lowered it: the efficacyefficacy andand safetyresultssafety of
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 3 (lowers risk) · Design
Responsible party: not given (raises risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Has a data monitoring committee: not given (lowers risk) · Design
Design: parallel (raises risk) · Design
Drug's FAERS reports with a death: 10.5% (lowers risk) · Drug's FDA history
Blinding: quadruple (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Disease area, cancer: No (lowers risk) · Disease area
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: 71.7% (lowers risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Disease area, neurology: No (lowers risk) · Disease area
Keywords listed: 0 (raises 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: 2
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: quadruple (typical: none)
Has a data monitoring committee: not given (typical: 56% yes)
Responsible party: not given (typical: sponsor)
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 65 (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: 2 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 53191 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 14096 (typical: 412.5)
Drug's FAERS reports marked serious: 71.7% (typical: 85.6%)
Drug's FAERS reports with a death: 10.5% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: escitalopram, quetiapine

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

Quetiapine Prolong, Escitalopram and Hypothalamic-pituitary-adrenocortical (HPA) Axis Activity in Depressed Patients NCT00953108 · started 2009 · scored riskier than 20% of active trials completed
Quetiapine Extended Release (XR) in Bipolar Patients With Comorbid Generalized Anxiety Disorder (GAD) NCT00671853 · started 2008 · scored riskier than 64% of active trials completed
Efficacy of Quetiapine XR Versus Placebo as Concomitant Treatment to Mood Stabilizers in the Control of Subsyndromal Symptoms of Bipolar Disorder NCT01197846 · started 2010 · scored riskier than 28% of active trials completed
Effect of Quetiapine XR on Sleep in Patients With Major Depression, as Compared With Mirtazapine NCT00782405 · started 2008 · scored riskier than 36% of active trials completed
Levomilnacipran ER vs. Adjunctive Quetiapine for Adults With Inadequate Relief With SSRIs in MDD NCT02720198 · started 2017 · scored riskier than 50% 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.