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:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-24 @ 5:28 PM
NCT ID:
NCT06665568
Eligibility Criteria:
Inclusion Criteria (patients):
* Informed Consent as documented by signature;
* HADS total score of 6 or greater;
* Age 18 years or older;
* Progressive cancer diagnosis (estimated life expectancy 24 months or more)
* Able to attend study visits;
* Ability to speak and understand German;
Exclusion Criteria (patients):
* Clinician assessed cognitive impairment;
* Clinician assessed alcohol or drug abuse;
* Pregnancy or breast-feeding;
* Severe hypertension (greater than 200/120 mmHg);
* Anamnestic mood disorder (major depressive disorder, treatment resistant depression, etc.);
* Suicidality (C-SSRS total score of "low" or less);
* Weight less than 39 kg, greater than 170 kg;
* Angina pectoris or myocardial infarction in the last 6 months;
* Lifetime abuse or dependence on ketamine or phencyclidine;
* Substance abuse or dependence in the 6 months before screen;
* Nasal obstructions or history of nasal surgery.
* Serious health risk caused by increased blood pressure or intracranial pressure:
* Known aneurysmal vascular disease (including intracranial, thoracic or abdominal aortic or peripheral arterial vessels);
* Known history of intracerebral hemorrhage;
* Recent (within 6 weeks) cardiovascular event including myocardial infarction (MI).
Inclusion criteria (caregivers):
* Informed Consent as documented by signature;
* Age 18 years or older;
* Able to attend study visits;
* Ability to speak and understand German.
Exclusion criteria (caregivers):
\- None.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06665568
Study Brief:
Protocol Section:
NCT06665568