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

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00480207
• Other study ID #: ICHN-4413
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 28, 2007
• Last updated: November 5, 2012
• Start date: May 2007
• Est. completion date: October 2008

Study information

• Verified date: November 2012
• Source: Beersheva Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Age 65+ (year of birth -1942 or below)

2. Depression (as defined by the DSM-IV diagnostic criteria for depression: major or minor depression or dysthymia)

Exclusion Criteria:

1. Co-existing psychiatric disorder (except anxiety disorders)

2. Moderate and severe cognitive impairment

3. Current treatment with anticoagulants, antithrombotics and fibrinolytics

4. Current severe angina with exertion

5. Chronic renal insufficiency

6. Liver cirrhosis

7. Alcohol or drug abuse

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Depression

Intervention

Dietary Supplement:
• folic acid

• omega-3

• vit B12

Other:
• folic acid placebo

• omega-3 placebo

Locations

Country	Name	City	State
Israel	Mental Health Center	Beer-Sheva

Sponsors (2)

Lead Sponsor	Collaborator
Prof. RH Belmaker	The S. Daniel Abraham International Center for Health and Nutrition

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the severity of depressive symptoms		baseline, 4th , 8th and 12th week	No
Secondary	cognitive status		baseline, 4th, 8th, and 12th week	No
Secondary	nutritional status		baseline and end of study	No
Secondary	possible side effects		baseline, 4th, 8th, and 12th week	No