NCT00480207

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2 depression

Timeline
Completed

Started May 2007

Shorter than P25 for phase_2 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

November 6, 2012

Status Verified

November 1, 2012

Enrollment Period

1.4 years

First QC Date

May 28, 2007

Last Update Submit

November 5, 2012

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • the severity of depressive symptoms

    baseline, 4th , 8th and 12th week

Secondary Outcomes (3)

  • cognitive status

    baseline, 4th, 8th, and 12th week

  • nutritional status

    baseline and end of study

  • possible side effects

    baseline, 4th, 8th, and 12th week

Study Arms (4)

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)

Dietary Supplement: folic acidDietary Supplement: omega-3Dietary Supplement: vit B12

omega-3, folic acid placebo, vit B12

EXPERIMENTAL

omega-3,folic acid placebo (starch), vitamin B12 (1000 mcg per day)

Dietary Supplement: omega-3Dietary Supplement: vit B12Other: folic acid placebo

omega-3 placebo, folic acid, vit B12

EXPERIMENTAL

folic acid, omega-3 placebo(canola oil),vitamin B12 (1000 mcg per day)

Dietary Supplement: folic acidDietary Supplement: vit B12Other: 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)

Dietary Supplement: vit B12Other: folic acid placeboOther: omega-3 placebo

Interventions

folic acidDIETARY_SUPPLEMENT
omega-3 placebo, folic acid, vit B12omega-3, folic acid, vitB12
omega-3DIETARY_SUPPLEMENT
omega-3, folic acid placebo, vit B12omega-3, folic acid, vitB12
vit B12DIETARY_SUPPLEMENT
omega-3 placebo, folic acid placebo, vit B12omega-3 placebo, folic acid, vit B12omega-3, folic acid placebo, vit B12omega-3, folic acid, vitB12
folic acid placeboOTHER
omega-3 placebo, folic acid placebo, vit B12omega-3, folic acid placebo, vit B12
omega-3 placeboOTHER
omega-3 placebo, folic acid placebo, vit B12omega-3 placebo, folic acid, vit B12

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mental Health Center

Beersheba, Israel

Location

Related Publications (1)

  • 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.

    PMID: 34817851DERIVED

MeSH Terms

Conditions

Depression

Interventions

Folic AcidDocosahexaenoic AcidsVitamin B 12

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsFatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsCorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds, 4 or More RingsMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Danit R Shahar, RD PhD

    Ben-Gurion University of the Negev

    STUDY DIRECTOR

  • Alex Palatnik, MD

    Beersheva Mental Health Center

    PRINCIPAL INVESTIGATOR

  • Larissa German, MD, MMedSc

    The S. Daniel Abraham International Center for Health and Nutrition

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. RH Belmaker

Study Record Dates

First Submitted

May 28, 2007

First Posted

May 30, 2007

Study Start

May 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

November 6, 2012

Record last verified: 2012-11

Locations

IL(1)