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:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
NCT ID:
NCT06121206
Eligibility Criteria:
Inclusion Criteria (substudy 1):
* 18-50 years
* No psychiatric history
* Fluency in Danish
Inclusion Criteria (substudy 2):
* 18-65 years
* International Classification of Diseases (ICD)-10 diagnosis of Bipolar Disorder or depression confirmed with the Schedules for Clinical Assessment in Neuropsychiatry (SCAN)
* Fluency in Danish
* Partial or full remission (defined as a score of ≤14 on the Hamilton Depression Rating Scale 17-items (HDRS-17) and the Young Mania Rating Scale (YMRS)
* Objectively-verified cognitive impairment according to Screen for Cognitive Impairment in Psychiatry (SCIP) and/or self-reported cognitive impairment measured with Cognitive Complaints in Bipolar disorder Rating Assessment (COBRA). For SCIP, their performance must be ≥0.5 standard deviations (SD) below their demographically adjusted expected total SCIP score or on minimum 2 SCIP subtest scores. For COBRA, patients must report substantial cognitive impairment defined as a score ≥14.
Common Exclusion Criteria:
* Schizophrenia or schizoaffective disorder
* Neurological disorder
* Alcohol or substance abuse
* History of serious head trauma
* Previous altitude sickness
* Heart disease
* Diabetes
* Renal failure
* Untreated/insufficiently treated hypertension
* Thromboses or thromboembolic events
* First-degree family with thromboembolic events before age 60
* Pregnancy
* Breastfeeding
* Smoking or use other nicotine products regularly
* BMI\>30
* Electroconvulsive therapy (ECT) 3 months prior to participation
* Dyslexia
* Claustrophobia (MRI scans)
* Pacemaker and/or other MRI incompatible metal implants (MRI scans)
* Participation in experiments with radioactivity (\>10 mSv) within the last year (PET scans)
* Significant occupational exposure to radioactivity (PET scans)
* Medication incompatible with study aims (e.g., SV2A binding agents; PET scans)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06121206
Study Brief:
Protocol Section:
NCT06121206