- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05972798
Exploration of the Potential Mechanisms of n-3 Fatty Acids Supplementation in Depression and Cognitive Function in Patients With Late-life Depression
Exploration of the Potential Mechanisms of n-3 Fatty Acids Supplementation in Depression and Cognitive Function in Patients With Late-life Depression by Using Multi-modal Neuroimaging Methods
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Depression in the elderly causes considerable distress, disability, and loss of life. The accelerating aging boom is accentuating the importance of addressing late life depression (LLD).Extensive efforts in searching for effective and safety treatment yielded unsatisfactory results.Among the multiple agents in LLD treatment, long-chain polyunsaturated omega-3 fatty acids(omega-3 PUFA) stands out as an interesting compound as it addressed two main features in LLD,depressive mood and cognitive function. However, how it affects the brain remains unknown.Therefore, in an on-going double-blind randomized placebo-controlled study using 48 weeks omega-3 PUFA supplement in LLD treatment, we plan to perform two MRI scans (pre-treatment and post-treatment), in an effort to understand the unique neurobiology of omega-3 PUFA in the treatment of LLD. Along the trial, neuropsychological function and associated inflammatory markers were also collected.
From past study, what separates LLD from mid-life depression lying in two key features that distinguish the brain in the elderly versus young individuals are cerebrovascular disease (CVD) and neurodegeneration. We conceptualize the cognitive and emotional dysfunction in LLD is obscured by the overlay of age-related brain abnormalities (e.g., white matter disease, atrophy, neurodegeneration, etc.), which could be ameliorated by the supplement omega-3 PUFA. We also expected functionally distinct brain regions (ex: amygdala in emotional processing, hippocampus in memory encoding) will demonstrate between group differences in the activation changes across trial. Moreover, all these neuroimaging changes may be mediated by concomitant changes in inflammatory markers or neuropsychological profiles, validating the mechanism of action in omega-3 PUFA as anti-inflammation.
With the help with multi-modal neuroimaging approach, we can assimilate these findings into an 'integrative neurobiological systems". We expect our findings would pin-point omega-3 PUFA's antidepressant effect in the brain level and solve its underlying biological mechanism.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Keelung, Taiwan
- Che-min Lin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age > 60 years.
- Previous major depressive disorder (MDD), single or recurrent.
- Mood is relatively stable for at least 3 weeks and the score of 17-item Hamilton Depression Rating Scale (HAMD-17) less than 10
Exclusion Criteria:
- Inability to provide informed consent.
- Depressive symptoms severe enough (i.e., HAMD-17 >= 10) at the baseline.
- Dementia, as defined by MMSE < 24 and clinical evidence of dementia.
- Lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms.
- Abuse of or dependence on alcohol or other substances within the past 3 months, and confirmed by study physician interview.
- High risk for suicide (e.g., active SI and/or current/recent intent or plan) AND unable to be managed safely in the clinical trial (e.g., unwilling to be hospitalized). Urgent psychiatric referral will be made in these cases.
- Non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).
- Unstable medical illness, including delirium, uncontrolled diabetes mellitus, hypertension, hyperlipidemia, or cerebrovascular or cardiovascular risk factors that are not under medical management. This will be determined based on information from the patient's personal physician and study physician's clinical judgment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Omega-3 fatty acids
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2.2 g/d omega-3 PUFAs (1.2g EPA and 1g DHA per day) in patients with LLD
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Placebo Comparator: Soybean oil
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Soybean oil in patients with LLD
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Loneliness UCLA
Time Frame: Change from Baseline at 52 weeks
|
the severity of loneliness (the score range from 20-80,the lower score means worse)
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Change from Baseline at 52 weeks
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Ham D-17
Time Frame: Change from Baseline at 52 weeks
|
the insight(the score range from 0-2,the higher score means worse)
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Change from Baseline at 52 weeks
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Geriatric Depression Geriatric Depression Scale-15
Time Frame: Change from Baseline at 52 weeks
|
the insight(the score range from 0-1,the higher score means worse)
|
Change from Baseline at 52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Change from Baseline at 52 weeks
|
Sleep related scales
|
Change from Baseline at 52 weeks
|
Hamilton Rating Scale for Anxiety (HAM-A)
Time Frame: Change from Baseline at 52 weeks
|
the insight(the score range from 0-56,the higher score means worse)
|
Change from Baseline at 52 weeks
|
Verbal Learning & Memory
Time Frame: Change from Baseline at 52 weeks
|
Word list of Wechsler Memory Scale-III Face memory task(the score range from 0-48,the higher score means better)
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Change from Baseline at 52 weeks
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structural and functional connectivity
Time Frame: Change from Baseline at 52 weeks
|
Brain MRI connectivity change
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Change from Baseline at 52 weeks
|
Mini-Mental State Examination (MMSE)
Time Frame: Change from Baseline at 52 weeks
|
The test consists of questions that assess orientation to place and time, learning and memory, construction ability, attention, and calculation skill.
|
Change from Baseline at 52 weeks
|
Total Brain-derived neurotrophic factor
Time Frame: Change from Baseline at 52 weeks
|
Total BDNF
|
Change from Baseline at 52 weeks
|
Free Brain-derived neurotrophic factor
Time Frame: Change from Baseline at 52 weeks
|
Free BDNF
|
Change from Baseline at 52 weeks
|
Interleukin-6
Time Frame: Change from Baseline at 52 weeks
|
IL-6
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Change from Baseline at 52 weeks
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Interleukin-1β
Time Frame: Change from Baseline at 52 weeks
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IL-1β
|
Change from Baseline at 52 weeks
|
Interleukin-12
Time Frame: Change from Baseline at 52 weeks
|
IL-12
|
Change from Baseline at 52 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201701653B0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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