DeliriumPhase 3MIND-USANCT01211522

The Modifying the Impact of ICU-Associated Neurological Dysfunction-USA (MIND-USA) Study

A Phase 3 study testing Haloperidol and Ziprasidone in people with Delirium and Impaired Cognition, run by Vanderbilt University Medical Center at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Delirium, Impaired Cognition, Long Term Psychologic Disorders
What is being tested?: Haloperidol and Ziprasidone
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 566 participants
Where: 16 sitesUnited States
Study dates: 14 Dec 2011to 19 Jul 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

adult patients (≥18 years old)
in a medical and/or surgical ICU
on mechanical ventilation or non-invasive positive pressure ventilation (NIPPV), and/or requiring vasopressors due to shock
delirious (according to the CAM-ICU)

Who cannot join

Rapidly resolving organ failure criteria, indicated by planned immediate discontinuation of mechanical ventilation, NIPPV, and/or vasopressors at the time of screening for study enrollment
Pregnancy or breastfeeding (negative pregnancy test required prior to enrollment of female patients of childbearing age)
Severe dementia or neurodegenerative disease, defined as either impairment that prevents the patient from living independently at baseline or IQCODE >4.5, measured using a patient's qualified surrogate, mental illness requiring long-term institutionalization, acquired or congenital mental retardation, Parkinson's disease, Huntington's disease, and/or coma or another severe deficit due to structural brain disease such as stroke, intracranial hemorrhage, cranial trauma, intracranial malignancy, anoxic brain injury, or cerebral edema.
History of torsades de pointes, documented baseline QT prolongation (congenital long QT syndrome), or QTc >500 ms at screening due to refractory electrolyte abnormalities, other drugs, or thyroid disease
Ongoing maintenance therapy with typical or atypical antipsychotics
History of neuroleptic malignant syndrome (NMS), haloperidol allergy, or ziprasidone allergy
Expected death within 24 hours of enrollment or lack of commitment to aggressive treatment by family or the medical team (e.g., likely withdrawal of life support measures within 24 hours of screening)
Inability to obtain informed consent from an authorized representative within 72 hours of meeting all inclusion criteria, i.e., developing qualifying organ dysfunction criteria.

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

University of Michigan Health System
Ann Arbor, Michigan, 48109-5360
University of Maryland Medical Center
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114-2696
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7248
The Ohio State Medical Center
Columbus, Ohio, 43210-1228
Baylor Health Care System
Dallas, Texas, 75206
Denver Health/University of Colorado Health Sciences Center
Denver, Colorado, 80204-4507
Moses Cone Health System
Greensboro, North Carolina, 27410
Indiana University
Indianapolis, Indiana, 46202-2915
University of Iowa
Iowa City, Iowa, 52242
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-8300
Yale University Medical Center
New Haven, Connecticut, 06520-8057
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-6205
University of Washington
Seattle, Washington, 98195-9472
Albert Einstein Medical College-Montefiore Medical Center
The Bronx, New York, 10461

Other trials in United States

About this study

Official title: MIND-USA Study: Modifying the Impact of ICU-Associated Neurological Dysfunction

The long-term objective of the MIND-USA (Modifying the Impact of ICU-Induced Neurological Dysfunction-USA) Study is to define the role of antipsychotics in the management of delirium in vulnerable critically ill patients. We and others have shown that delirium is an independent predictor of more death, longer stay, higher cost, and long-term cognitive impairment often commensurate with moderate dementia. The rapidly expanding aging ICU population is especially vulnerable to develop delirium, with 7 of 10 medical and surgical ICU patients developing this organ dysfunction. Antipsychotics are the first-line pharmacological agents recommended to treat delirium, and over the past 30 years they gained widespread use in hospitalized patients globally prior to adequate testing of efficacy and safety for this indication. Haloperidol, the most commonly chosen antipsychotic, is used by over 80% of ICU doctors for delirium, while atypical antipsychotics are prescribed by 40%. Antipsychotics safety concerns include lethal cardiac arrhythmias, extrapyramidal symptoms, and the highly publicized increased mortality associated with their use in non-ICU geriatric populations. The overarching hypothesis is that administration of typical and atypical antipsychotics-haloperidol and ziprasidone, in this case-to critically ill patients with delirium will improve short- and long-term clinical outcomes, including days alive without acute brain dysfunction (referred to as delirium/coma-free days or DCFDs) over a 14-day period; 30-day, 90-day, and 1-year survival; ICU length of stay; incidence, severity, and/or duration of long-term neuropsychological dysfunction; and quality of life at 90-day and 1-year. To test these hypotheses, the MIND-USA Study will be a multi-center, double-blind, randomized, placebo-controlled investigation in 561 critically ill, delirious medical/surgical ICU patients who are (a) on mechanical ventilation or non-invasive positive pressure ventilation or (b) in shock on vasopressors. In each group (haloperidol, ziprasidone, and placebo), 187 patients will be enrolled and treated until delirium has resolved for 48 hours or to 14 days (whichever occurs first) and followed for 1 year.

Read the detailed description

The primary and secondary outcomes of the MIND-USA investigation will be analyzed both according to the individual comparisons by group of "haloperidol treated" vs. "placebo treated" and "ziprasidone treated" vs. "placebo treated" and also the combined grouping of both antipsychotics ("haloperidol plus ziprasidone treated" patients vs. "placebo treated" patients). In the latter third of the study, as a result of a paper by Patel S et al AJRCCM 2014 about rapidly reversible delirium (RRD), we considered modifying delirium assessments to detect those who might convert from CAM-ICU positive to negative following SATs, but we estimated that only 5 patients per arm would be in this category (and indeed <20 per arm in the entire study using the 10% rate published by Patel). With such low numbers and the assurance that through randomization we would have all groups analyzed similarly according to the study drug assignment, we elected not to alter the protocol and not to conduct subgroup analyses according to RRD status.

Conditions: Delirium, Impaired Cognition, Long Term Psychologic Disorders
Being tested: Haloperidol, Ziprasidone, Placebo
Keywords: Delirium, Intensive care, Mechanical ventilation, Antipsychotic, Haloperidol, Ziprasidone, Randomized, Placebo, Sepsis, Sedation, Long-term cognitive impairment
Medical subject headings: Delirium, Cognition Disorders, Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HaloperidolDrug
Also called Haldol
Haloperidol, up to 10mg q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes at concentrations of 5mg/mL. Patient will only receive IV while in the ICU.
ZiprasidoneDrug
Also called Geodon
Ziprasidone, up to 20mg q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes at concentrations of 10mg/mL. Patient will only receive IV while in the ICU.
PlaceboDrug
Placebo, up to 10mL q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes. Patient will only receive IV while in the ICU.

Study groups in NCT01211522
Study group	Role	What they receive
Haloperidol	Experimental	Haloperidol Receives: Drug: Haloperidol
Ziprasidone	Experimental	Ziprasidone Receives: Drug: Ziprasidone
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Delirium/Coma-free Days (DCFDs)
Defined as the number of days during the 14-day intervention period (beginning on the day of randomization) that the patient was alive and experienced neither delirium nor coma.
Measured: 14 days

Secondary outcomes (9)

Mortality
Deaths within the specified timeframe
Measured: 30-day and 90-day
Delirium Duration
Duration of delirium during the intervention period
Measured: 14 days
Number of Participants With Torsades de Pointes
Measured: 14 days plus 4-day post-study drug period (if longer than 14 days)
Number of Participants With Extrapyramidal Symptoms
Measured: 14 days plus 4-day post-study drug period (if longer than 14 days)
Number of Participants With Neuroleptic Malignant Syndrome
Measured: 14 days plus 4-day post-study drug period (if longer than 14 days)
Time to Liberation From Mechanical Ventilation
Days from randomization to successful liberation from mechanical ventilation, where "successful" indicates that liberation was followed by at least 48 hours alive and without reinitiation of invasive or noninvasive ventilation.
Measured: 30 days
Time to Final ICU Discharge
Days from randomization to final, successful ICU discharge, where "successful" indicates that discharge was followed by at least 48 hours alive. "ICU discharge" is represented by readiness for ICU discharge indicated by a physician order for transfer to a lower level of care even if a bed availability problems prevent actual discharge from the ICU.
Measured: 90 days
Time to ICU Readmission
Days from first ICU discharge to next ICU readmission.
Measured: 90 days after first ICU discharge
Time to Hospital Discharge
Days from randomization to successful hospital discharge, where "successful" indicates that discharge was followed by at least 48 hours alive.
Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Dec 201119 Jul 2018

First posted29 Sep 2010 (estimated)
Study start14 Dec 2011
Primary completion28 Aug 2017
Study completion19 Jul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for DeliriumStudies of the same condition, open and under way.
More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 566 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01211522
Sponsor's protocol ID: AG035117-01A1
Other IDs: 101082
Acronym: MIND-USA
Status last verified: Oct 2019
First submitted: 28 Sep 2010
Last updated: 18 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Boehm LM, Mart MF, LaNoue M, Siao SF, Pun BT, Bowton DL, Exline MC, Gong MN, Hite RD, Hough CL, Hyzy RC, Khan BA, Owens RL, Pisani MA, Rock P, Schmidt GA, Jackson JC, Ely EW, Girard TD, Brummel NE. Association between ABCDE bundle compliance and long-term outcomes: a secondary longitudinal analysis. Intensive Care Med. 2026 Mar;52(3):466-475. doi: 10.1007/s00134-026-08346-0. Epub 2026 Feb 25.
PubMed 41739187
Ahn S, LaNoue M, Su H, Moale AC, Scheunemann LP, Kiehl AL, Douglas IS, Exline MC, Gong MN, Khan BA, Owens RL, Pisani MA, Rock P, Jackson JC, Ely EW, Girard TD, Boehm LM. Post-Intensive Care Syndrome and Caregiver Burden: A Post Hoc Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e253443. doi: 10.1001/jamanetworkopen.2025.3443.
PubMed 40198074
Mart MF, Boehm LM, Kiehl AL, Gong MN, Malhotra A, Owens RL, Khan BA, Pisani MA, Schmidt GA, Hite RD, Exline MC, Carson SS, Hough CL, Rock P, Douglas IS, Feinstein DJ, Hyzy RC, Schweickert WD, Bowton DL, Masica A, Orun OM, Raman R, Pun BT, Strength C, Rolfsen ML, Pandharipande PP, Brummel NE, Hughes CG, Patel MB, Stollings JL, Ely EW, Jackson JC, Girard TD. Long-term outcomes after treatment of delirium during critical illness with antipsychotics (MIND-USA): a randomised, placebo-controlled, phase 3 trial. Lancet Respir Med. 2024 Aug;12(8):599-607. doi: 10.1016/S2213-2600(24)00077-8. Epub 2024 Apr 30.
PubMed 38701817
Stollings JL, Boncyk CS, Birdrow CI, Chen W, Raman R, Gupta DK, Roden DM, Rivera EL, Maiga AW, Rakhit S, Pandharipande PP, Ely EW, Girard TD, Patel MB. Antipsychotics and the QTc Interval During Delirium in the Intensive Care Unit: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2352034. doi: 10.1001/jamanetworkopen.2023.52034.
PubMed 38252439
Girard TD, Exline MC, Carson SS, Hough CL, Rock P, Gong MN, Douglas IS, Malhotra A, Owens RL, Feinstein DJ, Khan B, Pisani MA, Hyzy RC, Schmidt GA, Schweickert WD, Hite RD, Bowton DL, Masica AL, Thompson JL, Chandrasekhar R, Pun BT, Strength C, Boehm LM, Jackson JC, Pandharipande PP, Brummel NE, Hughes CG, Patel MB, Stollings JL, Bernard GR, Dittus RS, Ely EW; MIND-USA Investigators. Haloperidol and Ziprasidone for Treatment of Delirium in Critical Illness. N Engl J Med. 2018 Dec 27;379(26):2506-2516. doi: 10.1056/NEJMoa1808217. Epub 2018 Oct 22.
PubMed 30346242

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MIND-USA Study: Modifying the Impact of ICU-Associated Neurological Dysfunction
ClinicalTrials.gov ID: NCT01211522
Acronym / sponsor ID: MIND-USA / AG035117-01A1
Conditions: Delirium, Impaired Cognition, Long Term Psychologic Disorders
Keywords: Delirium, Intensive care, Mechanical ventilation, Antipsychotic, Haloperidol, Ziprasidone, Randomized, Placebo
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 566 participants (actual)
Lead sponsor: Vanderbilt University Medical CenterUniversity, hospital or other
Study start: 14 Dec 2011 (actual)
Primary completion: 28 Aug 2017 (actual)
Study completion: 19 Jul 2018 (actual)
First posted: 29 Sep 2010 (estimated)
Results: Posted 20 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Haloperidol	Experimental	Drug: HaloperidolHaloperidol
Ziprasidone	Experimental	Drug: ZiprasidoneZiprasidone
Placebo	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

adult patients (≥18 years old)
in a medical and/or surgical ICU
on mechanical ventilation or non-invasive positive pressure ventilation (NIPPV), and/or requiring vasopressors due to shock
delirious (according to the CAM-ICU)

Key exclusion criteria (8 listed)

Rapidly resolving organ failure criteria, indicated by planned immediate discontinuation of mechanical ventilation, NIPPV, and/or vasopressors at the time of screening for study enrollment
Pregnancy or breastfeeding (negative pregnancy test required prior to enrollment of female patients of childbearing age)
Severe dementia or neurodegenerative disease, defined as either impairment that prevents the patient from living independently at baseline or IQCODE >4.5, measured using a patient's qualified surrogate, mental illness requiring long-term institutionalization, acquired or congenital mental retardation, Parkinson's disease, Huntington's disease, and/or coma or another severe deficit due to structural brain disease such as stroke, intracranial hemorrhage, cranial trauma, intracranial malignancy, anoxic brain injury, or cerebral edema.
History of torsades de pointes, documented baseline QT prolongation (congenital long QT syndrome), or QTc >500 ms at screening due to refractory electrolyte abnormalities, other drugs, or thyroid disease
Ongoing maintenance therapy with typical or atypical antipsychotics

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HaloperidolAlso: HaldolHaloperidol, up to 10mg q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes at concentrations of 5mg/mL. Patient will only receive IV while in the ICU.	Drug	Haloperidol
ZiprasidoneAlso: GeodonZiprasidone, up to 20mg q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes at concentrations of 10mg/mL. Patient will only receive IV while in the ICU.	Drug	Ziprasidone
PlaceboPlacebo, up to 10mL q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes. Patient will only receive IV while in the ICU.	Drug	Placebo

Primary outcome

Delirium/Coma-free Days (DCFDs)
Time frame: 14 days
Defined as the number of days during the 14-day intervention period (beginning on the day of randomization) that the patient was alive and experienced neither delirium nor coma.

9 secondary outcomes

Mortality
Time frame: 30-day and 90-day
Delirium Duration
Time frame: 14 days
Number of Participants With Torsades de Pointes
Time frame: 14 days plus 4-day post-study drug period (if longer than 14 days)
Number of Participants With Extrapyramidal Symptoms
Time frame: 14 days plus 4-day post-study drug period (if longer than 14 days)
Number of Participants With Neuroleptic Malignant Syndrome
Time frame: 14 days plus 4-day post-study drug period (if longer than 14 days)
Time to Liberation From Mechanical Ventilation
Time frame: 30 days
Time to Final ICU Discharge
Time frame: 90 days
Time to ICU Readmission
Time frame: 90 days after first ICU discharge
Time to Hospital Discharge
Time frame: 90 days

Results and safety

Results posted to the registry on 20 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Haloperidol	192	189
Ziprasidone	190	183
Placebo	184	179

Primary outcome: Delirium/Coma-free Days (DCFDs)

Time frame: 14 days. Median (Inter-Quartile Range). Unit: days

Measure	Haloperidol n = 192	Ziprasidone n = 190	Placebo n = 184
Value	8 (0 to 11)	8 (2 to 11)	7 (0 to 11)

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: During the period when the patients were receiving a trial drug or placebo and for 4 days after discontinuation, we assessed the patients for side effects. We also collected clinical outcomes data until hospital discharge or up to 90 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Haloperidol	3 of 192 (1.6%)	55 of 192 (28.6%)	73 of 192
Ziprasidone	1 of 190 (0.5%)	70 of 190 (36.8%)	65 of 190
Placebo	1 of 184 (0.5%)	56 of 184 (30.4%)	63 of 184

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41739187Boehm LM, Mart MF, LaNoue M, Siao SF, Pun BT, Bowton DL, Exline MC, Gong MN, Hite RD, Hough CL, Hyzy RC, Khan BA, Owens RL, Pisani MA, Rock P, Schmidt GA, Jackson JC, Ely EW, Girard TD, Brummel NE. Association between ABCDE bundle compliance and long-term outcomes: a secondary longitudinal analysis. Intensive Care Med. 2026 Mar;52(3):466-475. doi: 10.1007/s00134-026-08346-0. Epub 2026 Feb 25.
Derived from this study: PubMed 40198074Ahn S, LaNoue M, Su H, Moale AC, Scheunemann LP, Kiehl AL, Douglas IS, Exline MC, Gong MN, Khan BA, Owens RL, Pisani MA, Rock P, Jackson JC, Ely EW, Girard TD, Boehm LM. Post-Intensive Care Syndrome and Caregiver Burden: A Post Hoc Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e253443. doi: 10.1001/jamanetworkopen.2025.3443.
Derived from this study: PubMed 38701817Mart MF, Boehm LM, Kiehl AL, Gong MN, Malhotra A, Owens RL, Khan BA, Pisani MA, Schmidt GA, Hite RD, Exline MC, Carson SS, Hough CL, Rock P, Douglas IS, Feinstein DJ, Hyzy RC, Schweickert WD, Bowton DL, Masica A, Orun OM, Raman R, Pun BT, Strength C, Rolfsen ML, Pandharipande PP, Brummel NE, Hughes CG, Patel MB, Stollings JL, Ely EW, Jackson JC, Girard TD. Long-term outcomes after treatment of delirium during critical illness with antipsychotics (MIND-USA): a randomised, placebo-controlled, phase 3 trial. Lancet Respir Med. 2024 Aug;12(8):599-607. doi: 10.1016/S2213-2600(24)00077-8. Epub 2024 Apr 30.
Derived from this study: PubMed 38252439Stollings JL, Boncyk CS, Birdrow CI, Chen W, Raman R, Gupta DK, Roden DM, Rivera EL, Maiga AW, Rakhit S, Pandharipande PP, Ely EW, Girard TD, Patel MB. Antipsychotics and the QTc Interval During Delirium in the Intensive Care Unit: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2352034. doi: 10.1001/jamanetworkopen.2023.52034.
Derived from this study: PubMed 30346242Girard TD, Exline MC, Carson SS, Hough CL, Rock P, Gong MN, Douglas IS, Malhotra A, Owens RL, Feinstein DJ, Khan B, Pisani MA, Hyzy RC, Schmidt GA, Schweickert WD, Hite RD, Bowton DL, Masica AL, Thompson JL, Chandrasekhar R, Pun BT, Strength C, Boehm LM, Jackson JC, Pandharipande PP, Brummel NE, Hughes CG, Patel MB, Stollings JL, Bernard GR, Dittus RS, Ely EW; MIND-USA Investigators. Haloperidol and Ziprasidone for Treatment of Delirium in Critical Illness. N Engl J Med. 2018 Dec 27;379(26):2506-2516. doi: 10.1056/NEJMoa1808217. Epub 2018 Oct 22.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

E. Wesley Ely, MD, MPH principal investigator

Vanderbilt University Medical Center

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Haloperidol and Ziprasidone in people with Delirium and Impaired Cognition, run by Vanderbilt University Medical Center at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Delirium/Coma-free Days (DCFDs) (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01211522, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.