Status:
COMPLETED
Effects of Altitude-like Cognition Training on Neuroplasticity and Cognitive Functions
Lead Sponsor:
Mental Health Services in the Capital Region, Denmark
Collaborating Sponsors:
European Research Council
University of Copenhagen
Conditions:
Cognitive Impairment
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to investigate the effects of a three-week altitude-like cognition training intervention in healthy individuals (substudy 1) and symptomatically stable patients with...
Detailed Description
ALTIBRAIN aims to test a novel model, linking altitude-like oxygen manipulations, endogenous erythropoietin (EPO) in the brain, neuroplasticity and cognition. Specifically, ALTIBRAIN will determine wh...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
February 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2025
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT06121206
Start Date
February 1 2023
End Date
July 30 2025
Last Update
September 26 2025
Active Locations (1)
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1
Neurocognition and Emotion in Affective Disorders (NEAD) Centre, University of Copenhagen and Psychiatric Centre Copenhagen, Frederiksberg hospital
Copenhagen, Capital Region of Copenhagen, Denmark, 1353