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

This study is currently recruiting participants.

Verified by Beersheva Mental Health Center, May 2007

Sponsors and Collaborators:	Beersheva Mental Health Center The S. Daniel Abraham International Center for Health and Nutrition
Information provided by:	Beersheva Mental Health Center
ClinicalTrials.gov Identifier:	NCT00480207

Purpose

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.

Condition	Intervention	Phase
Depression	Drug: folic acid, omega-3, vit B12	Phase II Phase III

MedlinePlus related topics: Depression Mental Health

Drug Information available for: Folic acid Vitamin B 12 Hydroxocobalamin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Factorial Assignment

Further study details as provided by Beersheva Mental Health Center:

Primary Outcome Measures:

the severity of depressive symptoms

Secondary Outcome Measures:

cognitive status

Study Start Date:

May 2007

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480207

Contacts

Contact: Larissa German, MD, MMed Sc	+972-8-6477442	germanl@bgu.ac.il
Contact: Danit Shahar, RD, PhD	+972-8-6477452	dshahar@bgu.ac.il

Locations

Israel
Mental Health Center	Recruiting
Beer-Sheva, Israel
Contact: Alex Palatnik, MD +972-8-6401766
Principal Investigator: Alex Palatnik, MD
Sub-Investigator: Roland YA Bastiaans, MD
Mental Health Center	Recruiting
Beer-Sheva, Israel
Contact: Roland YA Bastiaans, MD +972-86401420 rolandbastiaans@yahoo.co.uk
Contact: Danit Shahar, RD, PhD +972-8-6477452 dshahar@bgu.ac.il
Principal Investigator: Alex Palatnik, MD
Sub-Investigator: Roland YA Bastiaans, MD

Sponsors and Collaborators

Beersheva Mental Health Center

The S. Daniel Abraham International Center for Health and Nutrition

Investigators

Study Director:	Danit R Shahar, RD PhD	Ben-Gurion University of the Negev
Principal Investigator:	Alex Palatnik, MD	Beersheva Mental Health Center
Principal Investigator:	Larissa German, MD, MMedSc	The S. Daniel Abraham International Center for Health and Nutrition

More Information

Study ID Numbers:	ICHN-4413
Study First Received:	May 28, 2007
Last Updated:	September 24, 2007
ClinicalTrials.gov Identifier:	NCT00480207
Health Authority:	Israel: Ethics Commission

Study placed in the following topic categories:

Folic Acid
Depression
Hydroxocobalamin

Vitamin B 12
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Vitamin B Complex
Hematinics
Therapeutic Uses
Growth Substances
Vitamins

Hematologic Agents
Physiological Effects of Drugs
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009