Status:
COMPLETED
Pathophysiology of Neurodegeneration in Late-life Depression (AV45+THK)
Lead Sponsor:
Chang Gung Memorial Hospital
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
50-90 years
Phase:
PHASE2
Brief Summary
Late-life depression has been frequently associated with cognitive impairment. Several meta-analyses consistently suggested that a history of depression approximately doubles an individual's risk for ...
Detailed Description
Visit 1, Screening assessments (Day 1) The purpose is to determine eligibility for the proposed study. Screening period may take place over several days to one week after the first visit. Screening a...
Eligibility Criteria
Inclusion
- Enrolled subjects will be 50 to 90 years of age. They should understand the content of consent and sign consent after the explanation of the benefits and possible side effects of this trial
- Patients with a clinical diagnosis of major depressive disorder according to the DSM -5 criteria (APA, 2013).
- Comparison subjects evaluated for lifetime absence of psychiatric illness by MINI interview (Sheehan et al., 1998).
- Fertile females must avoid becoming pregnant and must use adequate contraceptive methods for 30 days after administration of study radiotracer.
Exclusion
- Any subject has clinically definite diagnosis of dementia before study recruitment according to the NIA-AA criteria for possible or probable clinically-defined AD dementia ( McKhann, 2011) or the DSM -5 criteria for any type of dementia (APA, 2013).
- Any subject has clinically significant or unstable medical diseases including metabolic, renal, liver, lung or cardiovascular disorders including metabolic, renal, liver, lung or cardiovascular disorders
- Any subject has a current or past history of clinically significant neurological insults affecting brain structure or function like completed stroke, head injury or epilepsy
- Any subject has current alcohol or other substances abuse and/ or dependence within the recent one year, or previously prolonged history of substances abuse
- Any females who is pregnant or lactating
- General MRI, and/or PET exclusion criteria including subjects who are pregnant, or had received brain aneurysm surgery, or implanted pacemaker, mechanical valves or cochlear implant.
- Any subjects with history of severe allergic or anaphylactic reactions particularly to the study medication, or any subjects who are recognized as high risk of adverse effects by principle investigator.
Key Trial Info
Start Date :
March 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT03430869
Start Date
March 23 2018
End Date
December 31 2021
Last Update
January 26 2022
Active Locations (1)
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1
Chang Gung Memorial Hospital
Taoyuan District, Guishan, Taiwan, 333