Late Life DepressionNCT05972798
Exploration of the Potential Mechanisms of n-3 Fatty Acids Supplementation in Depression and Cognitive Function in Patients With Late-life Depression
A study testing Omega-3 fatty acids and Soybean oil in people with Late Life Depression, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Late Life Depression
- What is being tested?
- Omega-3 fatty acids and Soybean oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Sep 2018to 25 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Late Life Depression
- Being tested
- Omega-3 fatty acids, Soybean oil
- Keywords
- elderly depression, long-chain polyunsaturated omega-3 fatty acids, cognitive function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acidsOther
2.2 g/d omega-3 PUFAs (1.2g EPA and 1g DHA per day) in patients with LLD
Soybean oilOther
Soybean oil in patients with LLD
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 fatty acids | Experimental | 1. Age > 60 years.
2. Previous major depressive disorder (MDD), single or recurrent.
3. Mood is relatively stable for at least 3 weeks and the score of 17-item Hamilton Depression Rating Scale (HAMD-17) less than 10 Receives: Other: Omega-3 fatty acids |
| Soybean oil | Placebo comparator | 1. Age > 60 years.
2. Previous major depressive disorder (MDD), single or recurrent.
3. Mood is relatively stable for at least 3 weeks and the score of 17-item Hamilton Depression Rating Scale (HAMD-17) less than 10 Receives: Other: Soybean oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loneliness UCLA
the severity of loneliness (the score range from 20-80,the lower score means worse)
Measured: Change from Baseline at 52 weeks
Ham D-17
the insight(the score range from 0-2,the higher score means worse)
Measured: Change from Baseline at 52 weeks
Geriatric Depression Geriatric Depression Scale-15
the insight(the score range from 0-1,the higher score means worse)
Measured: Change from Baseline at 52 weeks
Secondary outcomes (10)
Pittsburgh Sleep Quality Index (PSQI)
Sleep related scales
Measured: Change from Baseline at 52 weeks
Hamilton Rating Scale for Anxiety (HAM-A)
the insight(the score range from 0-56,the higher score means worse)
Measured: Change from Baseline at 52 weeks
Verbal Learning & Memory
Word list of Wechsler Memory Scale-III Face memory task(the score range from 0-48,the higher score means better)
Measured: Change from Baseline at 52 weeks
structural and functional connectivity
Brain MRI connectivity change
Measured: Change from Baseline at 52 weeks
Mini-Mental State Examination (MMSE)
The test consists of questions that assess orientation to place and time, learning and memory, construction ability, attention, and calculation skill.
Measured: Change from Baseline at 52 weeks
Total Brain-derived neurotrophic factor
Total BDNF
Measured: Change from Baseline at 52 weeks
Free Brain-derived neurotrophic factor
Free BDNF
Measured: Change from Baseline at 52 weeks
Interleukin-6
IL-6
Measured: Change from Baseline at 52 weeks
Interleukin-1β
IL-1β
Measured: Change from Baseline at 52 weeks
Interleukin-12
IL-12
Measured: Change from Baseline at 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start25 Sep 2018
- Primary completion25 Sep 2018
- Study completion25 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late Life DepressionStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972798
- Sponsor's protocol ID
- 201701653B0
- Status last verified
- Jan 2018
- First submitted
- 25 Jul 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05972798
- Acronym / sponsor ID
- 201701653B0
- Conditions
- Late Life Depression
- Keywords
- elderly depression, long-chain polyunsaturated omega-3 fatty acids, cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- 25 Sep 2018 (actual)
- Study completion
- 25 Dec 2020 (actual)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 fatty acids | Experimental | Other: Omega-3 fatty acids1. Age > 60 years. 2. Previous major depressive disorder (MDD), single or recurrent. 3. Mood is relatively stable for at least 3 weeks and the score of 17-item Hamilton Depression Rating Scale (HAMD-17) less than 10 |
| Soybean oil | Placebo comparator | Other: Soybean oil1. Age > 60 years. 2. Previous major depressive disorder (MDD), single or recurrent. 3. Mood is relatively stable for at least 3 weeks and the score of 17-item Hamilton Depression Rating Scale (HAMD-17) less than 10 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 fatty acids2.2 g/d omega-3 PUFAs (1.2g EPA and 1g DHA per day) in patients with LLD | Other | Omega-3 fatty acids |
| Soybean oilSoybean oil in patients with LLD | Other | Soybean oil |
Primary outcome
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)
Ham D-17
Time frame: Change from Baseline at 52 weeks
the insight(the score range from 0-2,the higher score means worse)
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)
10 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change from Baseline at 52 weeks
Hamilton Rating Scale for Anxiety (HAM-A)
Time frame: Change from Baseline at 52 weeks
Verbal Learning & Memory
Time frame: Change from Baseline at 52 weeks
structural and functional connectivity
Time frame: Change from Baseline at 52 weeks
Mini-Mental State Examination (MMSE)
Time frame: Change from Baseline at 52 weeks
Total Brain-derived neurotrophic factor
Time frame: Change from Baseline at 52 weeks
Free Brain-derived neurotrophic factor
Time frame: Change from Baseline at 52 weeks
Interleukin-6
Time frame: Change from Baseline at 52 weeks
Interleukin-1β
Time frame: Change from Baseline at 52 weeks
Interleukin-12
Time frame: Change from Baseline at 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 fatty acids and Soybean oil in people with Late Life Depression, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loneliness UCLA (time frame: Change from Baseline at 52 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.