Testing melatonin for treating hypoactive delirium in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of melatonin in treating hypoactive delirium in adult patients aged 55 and older who are currently experiencing this condition. The study utilizes a randomized, controlled design, comparing melatonin to a placebo to assess improvements in delirium symptoms. The trial aims to address the lack of pharmacological treatment options for hypoactive delirium, which is often overlooked despite its prevalence and serious consequences. Participants will be evaluated using specialized assessment methods to confirm their eligibility based on specific delirium criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Participants fulfilling all of the following inclusion criteria are eligible for the study:

* Adult patients (aged 55 years or older)
* Current delirium (hypoactive type) detected by a specialised assessment method: ICDSC score \>2 and RASS score \< 0

Exclusion Criteria:

Participants meeting the following criteria are excluded from the study:

* Delirium prior to ICU admission
* Sleep disorder not caused by hypoactive delirium
* Sedation in the ICU
* Hypersensitivity to the studied substances (i.e., melatonin, placebo content)
* Age \<55 years
* Terminal state
* Status epilepticus or postictal states following seizures on electroencephalogram (EEG)
* Active psychosis
* Substance abuse in current medical history
* Dementia
* Pregnancy

Where it's running

• University Hospital Basel
  Basel, Switzerland Recruiting

Study contacts

• Principal investigator: Alexa Hollinger, MD — University Hospital, Basel, Switzerland
• Study coordinator: Alexa Hollinger, MD
• Email: alexa.hollinger@usb.ch
• Phone: +41786747130

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.