CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 110 enrolled / 110 target
Drug / intervention
Haloperidol +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03743649
NCT03743649Phase 2ActiveOn Track (1.3/mo)

Strategies for Persistent Agitated Delirium in Palliative Care

M.D. Anderson Cancer Center·interventional·Posted Nov 16, 2018·Updated Jun 15, 2026

In Brief

A Phase 2 clinical trial evaluating Haloperidol, Lorazepam, and 3 other interventions for Delirium and 3 related conditions. Active but no longer recruiting, targeting 110 participants across 3 sites in 2 countries.

Detailed Summary

This phase II/IIII trial studies how well haloperidol and lorazepam work in controlling symptoms of persistent agitated delirium in patients with cancer that has spread to other places in the body undergoing palliative care. Haloperidol and lorazepam may help in controlling symptoms of agitated delirium in patients with cancer and may lessen any distress that their caregivers may be experiencing.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil, United States

Timeline

Phase 2Active
20192020202120222023202420252026202720282029
First PostedNov 16, 2018
Enrollment StartJul 17, 2019
Primary CompletionDec 31, 2028
TodayJul 1, 2026
Enrollment to primary: 9.5 yearsPosted 7.6 years agoPrimary completion in 2.5 years

Arms & Interventions

Group I (haloperidol, placebo)experimental

Patients receive haloperidol IV over 3-15 minutes every 4 hours and then every hour as needed and placebo IV every 4 hours and then every hour as needed until discharge from palliative care unit.

Drug: HaloperidolOther: PlaceboOther: Quality-of-Life AssessmentOther: Questionnaire Administration
Group II (lorazepam, placebo)experimental

Patients receive lorazepam IV over 3-15 minutes every 4 hours and then every hour as needed and placebo IV every 4 hours and then every hour as needed until discharge from palliative care unit.

Drug: LorazepamOther: PlaceboOther: Quality-of-Life AssessmentOther: Questionnaire Administration
Group III (haloperidol, lorazepam)experimental

Patients receive haloperidol IV over 3-15 minutes every 4 hours and then every hour as needed and lorazepam IV over 3-15 minutes every 4 hours and then every hour as needed until discharge from palliative care unit.

Drug: HaloperidolDrug: LorazepamOther: Quality-of-Life AssessmentOther: Questionnaire Administration
Group IV (placebo, lorazepam)experimental

Patients receive two different placebos IV every 4 hours. Patients then receive placebo IV and lorazepam IV over 3-15 minutes every hour as needed until discharge from palliative care unit.

Drug: LorazepamOther: PlaceboOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

Haloperidoldrug

Given IV

Lorazepamdrug

Given IV

Placeboother

Given IV

Quality-of-Life Assessmentother

Ancillary studies

Questionnaire Administrationother

Ancillary studies