Late-Life DepressionNCT01235533
Fish Oil Supplementation in Late-life Depression
A study testing N-3 polyunsaturated fatty acids in people with Late-Life Depression, run by Taipei City Psychiatric Center, Taiwan at 2 sites in Taiwan.
Trial summary
To investigate whether fish oil supplementation, compared to placebo (olive oil), could have better effects on depression course and cognitive function in older people with major depression. 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?
- N-3 polyunsaturated fatty acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 2 sitesTaiwan
- Study dates
- May 2007to Sep 2010
- 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
- An age range of 60 years old or over;
- A previous diagnosis of major depressive disorder according to the Chinese version of Structured Clinical Interview for DSM IV-TR Axis-I Disorder;
- Depressive symptoms were stable for at least three consecutive weeks and the 17-item Hamilton Depression Rating Scale score less or equal to 10.
- Capacity to provide informed consent.
Who cannot join
- People with severe or acute medical illness ( such as metastatic cancer, brain tumor, decompensated cardiac, hepatic, or renal failure, or myocardial infarction or stroke) within the 3 months preceding the study.
- Those who had neurological disorders involving central nervous system, such as delirium, Parkinson's disease, aphasia or multiple sclerosis)
- Prominent cognitive impairment, defined as the Chinese version of Mini-Mental State examination score less than 17.
- People with alcoholism, defined by a score of 8 or higher in male and of 6 or higher in female on the Chinese version of the Alcohol Use Disorders Identification Test (AUDIT) questionnaire.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Chih-Chiang Chiu
Taipei, 110
Department of Psychiatry, Cathay General Hospital
Taipei
About this study
Official title: The Assessment for the Effects of Health Products on Depression and Cognitive Function:Fish Oil in Patients With Late-life Depression
To investigate whether fish oil supplementation, compared to placebo (olive oil), could have better effects on depression course and cognitive function in older people with major depression.
Read the detailed description
Patients with late-life depression were reported cognitive impairment, especially in information-processing speed, working memory, attention and episodic memory, even after depressive symptoms subside and some of them further progress to dementia in two to four years. Several epidemiological studies, fatty acid comparison studies, animal studies, and clinical trials found that omega-3 polyunsaturated fatty acids (PUFAs) were significantly associated with the major depression, cognitive decline in general population and Alzheimer's disease. Until now, there is no study investigating the effects of n-3 PUFAs on depressive symptoms and cognition in patients with late-life depression. Thus, the aims of this study were to investigate whether fish oil supplementation, compared to placebo (olive oil), could have better effects on depression course and cognitive function in older people with major depression.
- Conditions
- Late-Life Depression
- Being tested
- N-3 polyunsaturated fatty acids
- Keywords
- late-life depression, recurrence of depression, cognition, N-3 polyunsaturated fatty acids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-3 polyunsaturated fatty acidsDietary supplement
Also called Fish oil
Three capsules per day. Each capsule included 600mg eicosapentanoic acid (20:5n-3), 400 mg of docosahexanoic acid (22:6n-3), tertiary-butylhydroquinone 0.2 mg/g and tocopherols 2 mg/g.
| Study group | Role | What they receive |
|---|---|---|
| N-3 fatty acids | Experimental | Participants in this arm were received three capsules of n-3 fatty acids. Each capsule included 600mg eicosapentanoic acid (20:5n-3), 400 mg of docosahexanoic acid (22:6n-3), tertiary-butylhydroquinone 0.2 mg/g and tocopherols 2 mg/g。 Receives: Dietary Supplement: N-3 polyunsaturated fatty acids |
| Placebo | Placebo comparator | Participants in this arm were received three identical capsules per day. All capsules included olive oil. Receives: Dietary Supplement: N-3 polyunsaturated fatty acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of depression
Definition of recurrence of depression (between last visit and current visit):
- Fulfilled diagnosis of major depressive episode according to DSM-IV-TR
- Score of sucide subscale in 17-item Hamilton Depression Rating was 3 or over
- Hospitalization due to depression
Measured: week 8, 16, 24, 32, 40, 48
Secondary outcomes (1)
Change of cognitive function
Comparison of cognitive function at week 48 between two groups after adjustment for age, gender, education and baseline cognitive funciton
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2010 (estimated)
- Study startMay 2007
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Late-Life DepressionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei City Psychiatric Center, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Investigators
- CHIH-CHIANG CHIU, M.D., Principal investigator, Department of Psychiatry, Taipei City Psychiatric Center, Taipei City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235533
- Sponsor's protocol ID
- 95004-62-161
- Status last verified
- Nov 2010
- First submitted
- 4 Nov 2010
- Last updated
- 5 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Appleton KM, Voyias PD, Sallis HM, Dawson S, Ness AR, Churchill R, Perry R. Omega-3 fatty acids for depression in adults. Cochrane Database Syst Rev. 2021 Nov 24;11(11):CD004692. doi: 10.1002/14651858.CD004692.pub5.
PubMed 34817851
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment for the Effects of Health Products on Depression and Cognitive Function:Fish Oil in Patients With Late-life Depression
- ClinicalTrials.gov ID
- NCT01235533
- Acronym / sponsor ID
- 95004-62-161
- Conditions
- Late-Life Depression
- Keywords
- late-life depression, recurrence of depression, cognition, N-3 polyunsaturated fatty acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Taipei City Psychiatric Center, TaiwanUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- May 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 5 Nov 2010 (estimated)
- 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.
To investigate whether fish oil supplementation, compared to placebo (olive oil), could have better effects on depression course and cognitive function in older people with major depression.
Detailed description
Patients with late-life depression were reported cognitive impairment, especially in information-processing speed, working memory, attention and episodic memory, even after depressive symptoms subside and some of them further progress to dementia in two to four years. Several epidemiological studies, fatty acid comparison studies, animal studies, and clinical trials found that omega-3 polyunsaturated fatty acids (PUFAs) were significantly associated with the major depression, cognitive decline in general population and Alzheimer's disease. Until now, there is no study investigating the effects of n-3 PUFAs on depressive symptoms and cognition in patients with late-life depression. Thus, the aims of this study were to investigate whether fish oil supplementation, compared to placebo (olive oil), could have better effects on depression course and cognitive function in older people with major depression.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-3 fatty acids | Experimental | Dietary Supplement: N-3 polyunsaturated fatty acidsParticipants in this arm were received three capsules of n-3 fatty acids. Each capsule included 600mg eicosapentanoic acid (20:5n-3), 400 mg of docosahexanoic acid (22:6n-3), tertiary-butylhydroquinone 0.2 mg/g and tocopherols 2 mg/g。 |
| Placebo | Placebo comparator | Dietary Supplement: N-3 polyunsaturated fatty acidsParticipants in this arm were received three identical capsules per day. All capsules included olive oil. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- An age range of 60 years old or over;
- A previous diagnosis of major depressive disorder according to the Chinese version of Structured Clinical Interview for DSM IV-TR Axis-I Disorder;
- Depressive symptoms were stable for at least three consecutive weeks and the 17-item Hamilton Depression Rating Scale score less or equal to 10.
- Capacity to provide informed consent.
Key exclusion criteria (4 listed)
- People with severe or acute medical illness ( such as metastatic cancer, brain tumor, decompensated cardiac, hepatic, or renal failure, or myocardial infarction or stroke) within the 3 months preceding the study.
- Those who had neurological disorders involving central nervous system, such as delirium, Parkinson's disease, aphasia or multiple sclerosis)
- Prominent cognitive impairment, defined as the Chinese version of Mini-Mental State examination score less than 17.
- People with alcoholism, defined by a score of 8 or higher in male and of 6 or higher in female on the Chinese version of the Alcohol Use Disorders Identification Test (AUDIT) questionnaire.
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 |
|---|---|---|
| N-3 polyunsaturated fatty acidsAlso: Fish oilThree capsules per day. Each capsule included 600mg eicosapentanoic acid (20:5n-3), 400 mg of docosahexanoic acid (22:6n-3), tertiary-butylhydroquinone 0.2 mg/g and tocopherols 2 mg/g. | Dietary supplement | N-3 fatty acids, Placebo |
Primary outcome
Recurrence of depression
Time frame: week 8, 16, 24, 32, 40, 48
Definition of recurrence of depression (between last visit and current visit): 1. Fulfilled diagnosis of major depressive episode according to DSM-IV-TR 2. Score of sucide subscale in 17-item Hamilton Depression Rating was 3 or over 3. Hospitalization due to depression
1 secondary outcome
Change of cognitive function
Time frame: Week 48
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 5 Nov 2010.
- Derived from this study: PubMed 34817851Appleton KM, Voyias PD, Sallis HM, Dawson S, Ness AR, Churchill R, Perry R. Omega-3 fatty acids for depression in adults. Cochrane Database Syst Rev. 2021 Nov 24;11(11):CD004692. doi: 10.1002/14651858.CD004692.pub5.
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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.
CHIH-CHIANG CHIU, M.D. principal investigator
Department of Psychiatry, Taipei City Psychiatric Center, Taipei City Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-3 polyunsaturated fatty acids in people with Late-Life Depression, run by Taipei City Psychiatric Center, Taiwan at 2 sites 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 4 inclusion and 4 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 5 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Recurrence of depression (time frame: week 8, 16, 24, 32, 40, 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01235533, which also lists 1 linked publication.
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 5 Nov 2010.