DepressionPhase 2/3NCT00480207
Folic Acid and Omega -3 Fatty Acid Supplementation in Depressed Older Adults
A Phase 2/3 study testing folic acid, omega-3 and vit B12 in people with Depression, run by Prof. RH Belmaker at 1 site in Israel.
Trial summary
Our specific aim is to determine the impact of folic acid and omega-3 supplementation on the severity of depressive symptoms among depressed adults aged 65 and above. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Depression
- What is being tested?
- folic acid, omega-3 and vit B12
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- May 2007to Oct 2008
- Phase
- Phase 2/3
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65+ (year of birth -1942 or below)
- Depression (as defined by the DSM-IV diagnostic criteria for depression: major or minor depression or dysthymia)
Who cannot join
- Co-existing psychiatric disorder (except anxiety disorders)
- Moderate and severe cognitive impairment
- Current treatment with anticoagulants, antithrombotics and fibrinolytics
- Current severe angina with exertion
- Chronic renal insufficiency
- Liver cirrhosis
- Alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double-blind Controlled Clinical Trial to Assess the Impact of Folic Acid and Omega-3 Fatty Acids Supplementation on the Severity of Depressive Symptoms in Older Adults With Identified Depression
Our specific aim is to determine the impact of folic acid and omega-3 supplementation on the severity of depressive symptoms among depressed adults aged 65 and above.
- Conditions
- Depression
- Being tested
- folic acid, omega-3, vit B12, folic acid placebo, omega-3 placebo
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
folic acidDietary supplement
omega-3Dietary supplement
vit B12Dietary supplement
folic acid placeboOther
omega-3 placeboOther
| Study group | Role | What they receive |
|---|---|---|
| omega-3, folic acid, vitB12 | Experimental | folic acid (1600 mcg per day), and omega-3 (2000 mg per day: active docosahexaenoic acid (DHA) and eicosapentanoic acid (EPA), proportion 1:1), vitamin B12 (1000 mcg per day) Receives: Dietary Supplement: folic acid; Dietary Supplement: omega-3; Dietary Supplement: vit B12 |
| omega-3, folic acid placebo, vit B12 | Experimental | omega-3,folic acid placebo (starch), vitamin B12 (1000 mcg per day) Receives: Dietary Supplement: omega-3; Dietary Supplement: vit B12; Other: folic acid placebo |
| omega-3 placebo, folic acid, vit B12 | Experimental | folic acid, omega-3 placebo(canola oil),vitamin B12 (1000 mcg per day) Receives: Dietary Supplement: folic acid; Dietary Supplement: vit B12; Other: omega-3 placebo |
| omega-3 placebo, folic acid placebo, vit B12 | Experimental | omega-3 placebo (canola oil),folic acid placebo (starch), vitamin B12 (1000 mcg per day) Receives: Dietary Supplement: vit B12; Other: folic acid placebo; Other: omega-3 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the severity of depressive symptoms
Measured: baseline, 4th , 8th and 12th week
Secondary outcomes (3)
cognitive status
Measured: baseline, 4th, 8th, and 12th week
nutritional status
Measured: baseline and end of study
possible side effects
Measured: baseline, 4th, 8th, and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2007 (estimated)
- Study startMay 2007
- Primary completionOct 2008
- Study completionOct 2008
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 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. RH Belmaker
- Sponsor type
- Other government
- Collaborators
- The S. Daniel Abraham International Center for Health and Nutrition
- Responsible party
- Sponsor-investigator, Prof. RH Belmaker, Beersheva Mental Health Center
- Investigators
- Danit R Shahar, RD PhD, Study director, Ben-Gurion University of the NegevAlex Palatnik, MD, Principal investigator, Beersheva Mental Health CenterLarissa German, MD, MMedSc, Principal investigator, The S. Daniel Abraham International Center for Health and Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480207
- Sponsor's protocol ID
- ICHN-4413
- Status last verified
- Nov 2012
- First submitted
- 28 May 2007
- Last updated
- 6 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
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 6 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Controlled Clinical Trial to Assess the Impact of Folic Acid and Omega-3 Fatty Acids Supplementation on the Severity of Depressive Symptoms in Older Adults With Identified Depression
- ClinicalTrials.gov ID
- NCT00480207
- Acronym / sponsor ID
- ICHN-4413
- Conditions
- Depression
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Prof. RH BelmakerOther government
- Collaborators
- The S. Daniel Abraham International Center for Health and Nutrition
- Study start
- May 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 30 May 2007 (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.
Our specific aim is to determine the impact of folic acid and omega-3 supplementation on the severity of depressive symptoms among depressed adults aged 65 and above.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| omega-3, folic acid, vitB12 | Experimental | Dietary Supplement: folic acid, Dietary Supplement: omega-3, Dietary Supplement: vit B12folic acid (1600 mcg per day), and omega-3 (2000 mg per day: active docosahexaenoic acid (DHA) and eicosapentanoic acid (EPA), proportion 1:1), vitamin B12 (1000 mcg per day) |
| omega-3, folic acid placebo, vit B12 | Experimental | Dietary Supplement: omega-3, Dietary Supplement: vit B12, Other: folic acid placeboomega-3,folic acid placebo (starch), vitamin B12 (1000 mcg per day) |
| omega-3 placebo, folic acid, vit B12 | Experimental | Dietary Supplement: folic acid, Dietary Supplement: vit B12, Other: omega-3 placebofolic acid, omega-3 placebo(canola oil),vitamin B12 (1000 mcg per day) |
| omega-3 placebo, folic acid placebo, vit B12 | Experimental | Dietary Supplement: vit B12, Other: folic acid placebo, Other: omega-3 placeboomega-3 placebo (canola oil),folic acid placebo (starch), vitamin B12 (1000 mcg per day) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age 65+ (year of birth -1942 or below)
- Depression (as defined by the DSM-IV diagnostic criteria for depression: major or minor depression or dysthymia)
Key exclusion criteria (7 listed)
- Co-existing psychiatric disorder (except anxiety disorders)
- Moderate and severe cognitive impairment
- Current treatment with anticoagulants, antithrombotics and fibrinolytics
- Current severe angina with exertion
- Chronic renal insufficiency
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 |
|---|---|---|
| folic acid | Dietary supplement | omega-3 placebo, folic acid, vit B12, omega-3, folic acid, vitB12 |
| omega-3 | Dietary supplement | omega-3, folic acid placebo, vit B12, omega-3, folic acid, vitB12 |
| vit B12 | Dietary supplement | omega-3 placebo, folic acid placebo, vit B12, omega-3 placebo, folic acid, vit B12, omega-3, folic acid placebo, vit B12, omega-3, folic acid, vitB12 |
| folic acid placebo | Other | omega-3 placebo, folic acid placebo, vit B12, omega-3, folic acid placebo, vit B12 |
| omega-3 placebo | Other | omega-3 placebo, folic acid placebo, vit B12, omega-3 placebo, folic acid, vit B12 |
Primary outcome
the severity of depressive symptoms
Time frame: baseline, 4th , 8th and 12th week
3 secondary outcomes
cognitive status
Time frame: baseline, 4th, 8th, and 12th week
nutritional status
Time frame: baseline and end of study
possible side effects
Time frame: baseline, 4th, 8th, and 12th week
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 6 Nov 2012.
- 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.
Danit R Shahar, RD PhD study director
Ben-Gurion University of the Negev
Alex Palatnik, MD principal investigator
Beersheva Mental Health Center
Larissa German, MD, MMedSc principal investigator
The S. Daniel Abraham International Center for Health and Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing folic acid, omega-3 and vit B12 in people with Depression, run by Prof. RH Belmaker at 1 site in Israel.
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 2 inclusion and 7 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 6 Nov 2012. 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 Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
the severity of depressive symptoms (time frame: baseline, 4th , 8th and 12th week). 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 NCT00480207, 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 6 Nov 2012.