A Phase 2 interventional study of F-18 AV-45 and F-18-THK-5351 in Major Depressive Disorder, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 50 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-26.
Sponsored by Chang Gung Memorial Hospital · Phase 2, Interventional, and Diagnostic
Among 69 studies in Depressive Disorder, Major with a site in Taiwan — 13 open to participants now, 13 under way, 6 of them phase 3. Depressive Disorder, Major · Taiwan.
Among the 69 studies in Depressive Disorder, Major with a site in Taiwan, this one is the 49th largest by enrollment of the 64 interventional ones that give a count, is one of 2 that started in 2018, is one of 8 in phase 2, and was the 33rd registered.
3,046 studies on the registry are indexed under Depressive Disorder, Major; 592 are open to participants now.
Browse Depressive Disorder, Major studies →13 of the 69 studies in Depressive Disorder, Major with a site in Taiwan are open now. Recruiting first, the newest first:
Eli Lilly and Company · Sites in Taiwan, United States, Australia and 12 more countries
Ages 18–75
Janssen Research & Development, LLC · Sites in Taiwan, United States, Argentina and 4 more countries
Ages 18–74
Eli Lilly and Company · Sites in Taiwan, United States, Australia and 12 more countries
Ages 18–75
Janssen Research & Development, LLC · Sites in Taiwan, United States, Brazil and 4 more countries
Ages 12–17
National Science and Technology Council, Taiwan · Sites in Taiwan
Ages 50–80
A study can be open while its sites in Taiwan have not opened yet or have stopped. Only those recruiting at a site in Taiwan →
Of the 412 Depressive Disorder, Major studies recruiting now, 93 (23%) set no upper age limit and 293 (71%) stop at 75 or younger; 55 take children under 18; 98 take healthy volunteers.
This study: 50 Years to 90 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
69 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 9 · Phase 3 19 · Phase 4 10
First in 2005; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 59 is below the median of 80 across 2,532 interventional studies indexed under Depressive Disorder, Major.
Median enrollment 128 across the 64 interventional studies, 160 across the 5 observational. Of the 43 that completed or were terminated, 17 (40%) have results posted.
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27 of 69 have an industry lead sponsor. The 10 most frequent:
Chang Gung Memorial Hospital is the lead sponsor of 1,096 studies on the registry; 239 are open to participants now.
Chang Gung Memorial Hospital has 4 studies filed under Depressive Disorder, Major — fewer than ten, so there is no comparison to draw.
4 of the studies in Depressive Disorder, Major with a site in Taiwan that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04637620China Medical University HospitalNMDA Modulation in Major Depressive Disorder | 2026-11 |
| NCT05136755China Medical University HospitalNMDA Modulation in Antidepressant Nonresponders With Major Depressive Disorder | 2026-11 |
| NCT06821646National Taiwan University HospitalInvestigating the Brain's Physiological Responses in Depression and Autism, Using Transcranial Magnetic Stimulation and Electroencephalography | 2026-12-31 |
| NCT07500714National Science and Technology Council, TaiwanIntegrating Digital Phenotypes and AI-Driven Cognitive-Behavioral Therapy: Advancing Precision Medicine in Depression Through Digital Medicine | 2027-06 |
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Among the 69 studies in Depressive Disorder, Major with a site in Taiwan, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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 developing dementia later in life. Neurodegeneration may play an important component in late-life depression. The pathophysiology behind the link between late-life depression and the subsequent development of dementia largely remains unclear, and should be heterogeneous. This highlights the need to identify specific neurodegenerative pathways involved in late-life depression, which will facilitate research on mechanisms and new treatments in the future.
The recently published the National Institute on Aging and the Alzheimer Association (NIA-AA) criteria might provide new insights and frameworks to explore the patterns of neurodegenerative process in elderly depressed patients and to categorize them into different biomarker-based groups. In the present project, the investigators will recruit 40 patients with lifetime major depressive disorder, and 20 non-depressed cognitively normal comparison subjects. Alzheimer's disease pathology (A) was determined by measuring Aβ deposition by F-18 AV-45 PET, and neurodegeneration (N) was established by measuring hippocampal volume using MRI. Individuals were categorised as A-N-, A+N-, A+N+, or suspected non-Alzheimer's disease pathophysiology (A-N+, SNAP). All subjects will further undergo F-18-THK-5351 image study to detect underlying tau pathology. By doing this, the investigators will elucidate the neurodegenerative pathophysiology behind the link between depressive disorder and the subsequent development of dementia.
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 assessments will include:
Visit 2, Image study (Month 1±14 days) F-18 AV-45 PET study will be conducted for all subjects. PET data will be acquired using SIMENS PET/CT or PET/MRI scanner. For PET/CT protocol, a dynamic brain PET scan will be started simultaneously with the injection of F-18 AV-45 PET after a low-dose CT scan for patient positioning and attenuation correction. Instead of PET/CT, the investigators will also consider PET/MRI for better soft tissue contrast and limited radiation exposure for multiple scan session. However, the attenuation map delineated from MRI is not consistent, and the delicate PET/MRI protocol is still under evaluation. Vital sign will be checked before and at the end of the image study for all subjects. Subjects will be continuously observed for signs of adverse events or serious adverse events. Each study participant (or their caregiver if applicable) will be contacted by phone approximately 7-14 days after the PET imaging study or at the next follow-up visit of outpatient department to confirm their well-being and query them about any new adverse events. Study-emergent AEs will be monitored till resolution or relatively stable state.
Visit 3, Image study (Month 1±14 days) All participants will receive F-18-THK-5351 PET image study. PET data will be acquired using SIMENS PET/CT or PET/MRI scanner. For PET/CT protocol, a dynamic brain PET scan will be started simultaneously with the injection of F-18-THK-5351 after a low-dose CT scan for patient positioning and attenuation correction. Instead of PET/CT, the investigators will also consider PET/MRI for better soft tissue contrast and limited radiation exposure for multiple scan session. However, the attenuation map delineated from MRI is not consistent, and the delicate PET/MRI protocol is still under evaluation. Vital sign will be checked before and after the image study. Safety measurements include ECG, and clinical labs will be performed at the end of the image study for all subjects. Subjects will be continuously observed for signs of adverse events or serious adverse events. Each study participant (or their caregiver if applicable) will be contacted by phone approximately 7-14 days after the PET imaging study or at the next follow-up visit of outpatient department to confirm their well-being and query them about any new adverse events. Study-emergent AEs will be monitored till resolution or relatively stable state.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
F-18 AV-45 imaging
Drug: F-18 AV-45
F-18-THK-5351 imaging
Drug: F-18-THK-5351
In the present project, the investigators will recruit 40 patients with lifetime major depressive disorder, and 20 non-depressed cognitively normal comparison subjects. Alzheimer's disease pathology (A) was determined by measuring Aβ deposition by F-18 AV-45 PET.
In the present project, the investigators will recruit 40 patients with lifetime major depressive disorder, and 20 non-depressed cognitively normal comparison subjects. All subjects will further undergo F-18-THK-5351 image study to detect underlying tau pathology. By doing this, the investigators will elucidate the neurodegenerative pathophysiology behind the link between depressive disorder and the subsequent development of dementia.
The standard uptake value ratio (SUVR) of 18F-florbetapir
The primary outcome is to measure the standard uptake value ratio (SUVR) of 18F-florbetapir in patients with major depressive disorder and compare the difference between patients and non-depressed subjects. 18F-florbetapir SUVRs of each volume of interest are analyzed using whole the cerebellum as the reference region.
Time frame: three years
The standard uptake value ratio (SUVR) of 18F-THK-5351
The secondary outcome is to measure the standard uptake value ratio (SUVR) of 18F-THK-5351 in patients with major depressive disorder and compare the difference between patients and non-depressed subjects. 18F-THK-5351 SUVRs of each volume of interest are analyzed using the pons as the reference region.
Time frame: three years
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2018 to primary completion in Dec 2021, 45 months.
Of 99 non-industry phase 2 interventional studies under Depressive Disorder, Major, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 57. This study's 45 months is above that.
Counting every sponsor, half of 195 studies reached it within 22 months; a quarter within 14 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Chang Gung Memorial Hospital →