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OpenTrials
Completed

NCT Number: NCT00480207

Folic Acid and Omega -3 Fatty Acid Supplementation in Depressed Older Adults

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mental Health Center

Beersheba, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Folic Acid

Dietary Supplement

Omega-3

Dietary Supplement

Vit B12

Dietary Supplement

folic acid placebo

Other

omega-3 placebo

Other

Primary outcomes

  1. the severity of depressive symptoms

    Time frame: baseline, 4th , 8th and 12th week

Secondary outcomes

  1. cognitive status

    Time frame: baseline, 4th, 8th, and 12th week

  2. nutritional status

    Time frame: baseline and end of study

  3. possible side effects

    Time frame: baseline, 4th, 8th, and 12th week

Sponsors and collaborators

Lead sponsor

Prof. RH Belmaker

Other Gov

Collaborators

  • The S. Daniel Abraham International Center for Health and Nutrition

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 30, 2007
Registry last updated
Nov 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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