Depression Clinical Trial
Official title:
PET-MRI Biomarkers of Pathological Brain Aging in Late-life Depression
NCT number | NCT03849417 |
Other study ID # | S61968 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 19, 2019 |
Est. completion date | October 2023 |
This study investigates the relationships and differences in PET-MRI brain imaging biomarkers of abnormal aging and behavioral measures in late life depression compared to healthy controls, and evaluates relationships and differences in the same imaging and behavioral measures following electroconvulsive therapy. The study tests the hypotheses that late-life depression will be associated with higher levels of accelerated aging and brain disease biomarkers, and that electroconvulsive therapy works by stimulating the reorganization of brain tissue.The data collected with contribute to improved knowledge about the neurobiology of late-life psychopathology and its treatment.
Status | Recruiting |
Enrollment | 128 |
Est. completion date | October 2023 |
Est. primary completion date | October 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: - Diagnosis of late-life depression according to DSM 5 (patients only) - Age over 60 years old - Judged to be in good physical health by the investigator on the basis of medical history Exclusion Criteria: - history or evidence of psychiatric disease, as assessed by clinical interview (healthy controls only). - history of major other neurological disorder, or major internal pathology that may make him/her unfit for participation according to the interpretation by the investigator (including cardiac, lung, haematological, gastro-intestinal disorders or cancer); - current user (including ''recreational use'') of any illicit drugs,including cannabis, or has a history of drug or alcohol abuse; - had exposure to ionizing radiation (> 1 mSv) in other research studies within the last 12 months; - has a contra-indication for MRI scanning; - suffers from claustrophobia or cannot tolerate confinement during PET-MRI scanning procedures; cannot lie still for 60 minutes inside the scanner; - does not understand the study procedures - unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator; - underwent ECT within the last 3 months before enrollment (patients) |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Leuven | Leuven |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen Leuven | KU Leuven |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Relationship between synaptic density and hippocampal volume in LLD | Cross-sectional association between [11C]UCB-J binding (SUVR) and MRI-based assessment of hippocampal volume | 1 day | |
Primary | Relationship between tau and hippocampal volume in LLD | Cross-sectional association between [18F]MK-6240 binding (SUVR) and MRI-based assessment of hippocampal volume | 1 day | |
Primary | Relationship between tau and white matter (wm) pathology in LLD | Cross-sectional association between [18F]MK-6240 binding (SUVR) and MRI measures of white matter pathology (T2-FLAIR WMH/lesions, diffusion MRI measures in temporal lobe tracts) | 1 day | |
Primary | Effect of tau on medial temporal neural responses to emotional stimuli and functional connectivity in LLD | Cross-sectional association between [18F]MK-6240 binding (SUVR), fMRI based assessment of the emotion positivity effect, and fMRI derived resting state brain networks. | 1 day | |
Primary | Relationship between medial temporal pathology and stress | Association between [18F]MK-6240 binding (SUVR), hippocampal volume (MRI) and reactivity to stress (EMA) and wristband monitoring of heart rate and skin conductance. | 1 week | |
Primary | Relationship between hippocampal volume increase following ECT and changes in synaptic density and tau | Association between change in [11C]UCB-J and [18F]MK-6240 binding (SUVR) and MRI-based assessment of hippocampal volume one week following last ECT | 8 weeks | |
Primary | Amyloid changes following ECT | Change in [18F] Flutemetamol one week following the last ECT treatment | 8 weeks |
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