Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01211522 · ClinicalTrials.gov registry record · Phase 3
The Modifying the Impact of ICU-Associated Neurological Dysfunction-USA (MIND-USA) Study
A Phase 3 study of Delirium and Impaired Cognition, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 566
- Enrollment target
- 16
- Study locations
NCT01211522: Completed Phase 3 study of Delirium and Impaired Cognition, sponsored by Vanderbilt University Medical Center.
NCT01211522 is a Phase 3 study of Delirium and Impaired Cognition that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 566 participants, below the 879-participant average among 62 other Delirium trials with a reported enrollment target (36% lower). The trial reports 16 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01211522, a Phase 3 study of Delirium and Impaired Cognition, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 566 participants
- Enrollment target
- 16
- Study locations
Study Summary
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
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Haloperidol
- DRUG Ziprasidone
Study Locations (16)
Massachusetts
- Massachusetts General Hospital - Boston
- Brigham and Women's Hospital - Boston
North Carolina
- University of North Carolina - Chapel Hill - Chapel Hill
- Moses Cone Health System - Greensboro
Colorado
- Denver Health/University of Colorado Health Sciences Center - Denver
Connecticut
- Yale University Medical Center - New Haven
Indiana
- Indiana University - Indianapolis
Iowa
- University of Iowa - Iowa City
Maryland
- University of Maryland Medical Center - Baltimore
Michigan
- University of Michigan Health System - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 566 participants |
| Start Date | 2011-12-14 |
| Est. Completion | 2018-07-19 |
| Phase | Phase 3 |
What the finished NCT01211522 record still lists
NCT01211522 is an interventional study that assigns participants to a tested intervention. The registered 566 participants enrollment target is mid-sized for trials with a published cap, below the 879-participant average among 62 other Delirium trials with a reported enrollment target (36% lower).
The record links to 3 conditions, with Delirium appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01211522 lists 16 locations in 14 states (Massachusetts, North Carolina, Colorado).
Frequently Asked Questions
What is clinical trial NCT01211522 about?
NCT01211522 is a clinical study titled "The Modifying the Impact of ICU-Associated Neurological Dysfunction-USA (MIND-USA) Study". 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 dea...
What is the current status of trial NCT01211522?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 566 participants. The study started on 2011-12-14. Estimated completion is 2018-07-19.
What conditions does trial NCT01211522 study?
This clinical trial studies the following conditions: Delirium, Impaired Cognition, Long Term Psychologic Disorders.
What interventions are being tested in trial NCT01211522?
The interventions under investigation include: Placebo (DRUG), Haloperidol (DRUG), Ziprasidone (DRUG).
Who is sponsoring clinical trial NCT01211522?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01211522 being conducted?
This trial has 16 study locations across Colorado, Connecticut, Indiana, Iowa, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Delirium
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01211522's enrollment target sits among peer trials
566 13th of 62 higher than 50 of 62 other Delirium trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Delirium trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Mitigating Delirium With Fluvoxamine Treatment for Non-Cardiac Surgery
RECRUITING · Phase 3
-
Goal-Directed Sedation in Mechanically Ventilated Infants and Children
RECRUITING · Phase 3
-
Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)
RECRUITING · Phase 3
-
PANDORA: Delirium Prevention After Cardiac Surgery Using IV Acetaminophen to Prevent Postoperative Delirium in Older Cardiac Surgical Patients
ACTIVE NOT RECRUITING · Phase 3
-
The MENDS2 Study, Maximizing the Efficacy of Sedation and Reducing Neurological Dysfunction and Mortality in Septic Patients With Acute Respiratory Failure
COMPLETED · Phase 3
-
Researching Efficient Approaches to Delirium Identification-Sustaining Effective Translation
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05472441 · 568 participants · NA
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
- NCT06146725 · 564 participants
The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)
- NCT06188520 · 564 participants · Phase 1
A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors
- NCT06628453 · 564 participants · NA
CGM for Management of Type 2 Diabetes in Pregnancy
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI