Inositol Hexaphosphate: A Novel Treatment Strategy for Bipolar Disorder?
Model scores of the 29,894 trials active now.
Model score 12% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 13% of the time (651 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 2018-07-30, after 2014-05-31 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 2018-07-30. 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: subjectstolerabilitybipolardisorderdepression
Phrases that lowered it: efficacy andacidtrialthe efficacyaim -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Phase: 1 (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Design: parallel (raises risk) · Design
-
Responsible party: principal investigator (lowers risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Disease area, psychiatry: Yes (raises risk) · Disease area
-
Drug's FAERS reports with a death: 6.3% (lowers risk) · Drug's FDA history
-
Minimum age: 18 (raises risk) · Who can join
-
Maximum age: 75 (raises risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 3 (raises risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
-
Keywords listed: 8 (lowers risk) · Design
-
Drug's FAERS reports marked serious: 66.5% (lowers risk) · Drug's FDA history
-
Blinding: none (raises risk) · Design
-
Collaborators: 1 (raises risk) · Design
-
Has a data monitoring committee: No (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
- 2
- Allocation
- non randomized (typical: randomized)
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 8 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 75 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: academic or other)
- Sponsor's past trials
- 1 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 3 (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
- 40952 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 5043 (typical: 412.5)
- Drug's FAERS reports marked serious
- 66.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 6.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- inositol, lamotrigine
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
- Trehalose as add-on Therapy in Bipolar Depression NCT02800161 · started 2016 · scored riskier than 54% of active trials completed
- Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression NCT02600507 · started 2016 · scored riskier than 9% of active trials completed
- Phase 2 Clinical Trial of GH001 in Bipolar II Disorder NCT05839509 · started 2023 · scored riskier than 11% of active trials terminated
- Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder NCT00665366 · started 2008 · scored riskier than 22% of active trials completed
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group-comparison Trial of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode NCT00606281 · started 2008 · scored riskier than 17% 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.