Treatment of Hypoactive Delirium and Outcome Measures (NCT02345902) | Clinical Trial Compass
UnknownPhase 3
Treatment of Hypoactive Delirium and Outcome Measures
Mexico60 participantsStarted 2016-01
Plain-language summary
Haloperidol and Non-Pharmacologic Treatment are recognized treatments for delirium. This study will evaluate which is the best treatment for hypoactive delirium.
Who can participate
Age range
70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients who fulfill criteria for delirium according to CAM and DOSS
* Patients in hospitalization who are not receiving treatment for delirium
* Patients without treatment with antipsychotics for any other reason
* Patients whose legally proxy accepts to participate
Exclusion Criteria:
* Patients who have received pharmacologic treatment for delirium
* Patients with a corrected QT interval prolongation
* Patients who receive antipsychotics for any other reason
* Patients in another age group
* Patients whose legally proxy does not accept to participate
* Patients with dementia
* Patients with Parkinson disease
* Patients with arrythmias
* Patients with language or hearing disorders that impede communication
* Patients hospitalized in the Intensive Care Unit
* Patients who are receiving benzodiazepines and anticholinergics
* Patients with dopamine agonists or antagonists
* Patients who develop a severe neurologic disease
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in delirium severity
Timeframe: Participants will be followed at an expected average of nine days
Trial details
NCT IDNCT02345902
SponsorInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran