Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-25 @ 3:57 AM
NCT ID:
NCT00865202
Eligibility Criteria:
Inclusion Criteria:
* Included subjects will be 60 years and older undergoing an operation with a planned ICU admission post-operatively.
Exclusion Criteria:
* Medications that, when combined with tryptophan, increase the risk of serotonin syndrome. The classes of medications include:
* monoamine oxidase inhibitors
* selective serotonin reuptake inhibitors
* serotonin-norepinephrine reuptake inhibitors
* triptans
* opioids
* central nervous system stimulants
* bupropion
* St. John's Wort
* Patients who undergo an operation on their brain.
* Factors which prevent delirium assessment with the CAM-ICU: vision impairment or non-fluent English speakers.
* A lowered seizure threshold including:
* history of seizure disorder
* alcohol abuse defined by a high AUDIT score (\>8 females and \>13 males)
* benzodiazepine or barbiturate abuse within three months of the study
* OR a positive urine toxicology screen for alcohol, benzodiazepines or barbiturates.
* Significant liver disease (Child's class B or greater) or significant renal disease (Creatinine ≥2.0).
* History of Huntington's or Addison's disease. (As requested by the FDA)
* History of bipolar disorder or a psychotic disorder (such as a psychotic major depression, schizophrenia, schizoaffective disorder, or psychosis in Alzheimer's disease or other dementia). (As requested by the FDA)
* Women who are not post-menopausal. (As requested by the FDA)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT00865202
Study Brief:
Protocol Section:
NCT00865202