Beyond Ageing: A Study for the Prevention of Depression, Cognitive Impairment and the Improvement of Knowledge About Mental Health - Full Text View

Sponsors and Collaborators:	Australian National University Australian Government Department of Health and Ageing University of Sydney University of Adelaide
Information provided by:	Australian National University
ClinicalTrials.gov Identifier:	NCT00214682

Purpose

The purpose of this study is to determine whether folate and vitamin B12, physical activity and mental health literacy can prevent depression, and folate and vitamin B12 and physical activity can prevent cognitive impairment in older people. Also the study aims to assess the benefits for older people in improving their knowledge about mental health in relation to depression.

Condition	Intervention
Depression Depressive Disorder	Drug: Folate (400mcg) and Vitamin B12 (100 mcg) Behavioral: Physical activity Behavioral: Mental health literacy (knowledge about mental health problems)

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:	Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study
Official Title:	Beyond Ageing Project: A Randomized Controlled Trial to Assess the Benefit of Improving Mental Health Literacy in Depression as Well as the Effect of Folate and B12, and Physical Activity, in Preventing Major Depression and Cognitive Impairment Among Australians Aged 65-74 Years

Further study details as provided by Australian National University:

Primary Outcome Measures:

Depression [assessed at baseline, 6 weeks, 6 months, 12 months and 24 month follow-ups]

Secondary Outcome Measures:

Disability due to physical and mental health
Cognitive impairment
Physical activity levels
Physical health outcomes
B12 levels
Folate status
Homocysteine
Genotyping
Measured at baseline, 6 weeks, 6-, 12- and 24-months. However, dementia measures will be taken at baseline, 12 and 24-months and genotyping at baseline.

Estimated Enrollment:	2000
Study Start Date:	October 2005
Estimated Study Completion Date:	December 2008

Detailed Description:

While preventive efforts for depression have tended to focus on adolescent and young adult populations, other stages of the lifespan also provide opportunities for prevention. With older people, there are certain risk and aetiological factors, which become more prominent and require preventive action at that point in the lifespan. The aim of this study is to determine the efficacy of various interventions in preventing depression and cognitive decline among older people who are at high risk of developing major depression because they are currently suffering from depressive symptoms.

The study has three interventions; i) folate and vitamin B12, ii) physical activity; and iii) mental health literacy. Participants will be randomly allocated to receive each combination of the interventions (folate and vitamin B12 or placebo, physical activity intervention programme or physical activity no-intervention control, mental health literacy intervention [containing written modules with information about depression that is relevant to older people] or mental health literacy no-intervention control group). Participants will receive these interventions over a two-year period with regular assessments across that time period.

Eligibility

Ages Eligible for Study:	65 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Aged 65-74 years with some depressive symptoms, assessed using the Kessler 10 Psychological Distress Scale [K10] (Andrews & Slade, 2001)

Exclusion Criteria:

Any of the following:

Those currently taking medication or receiving psychological treatment for depression
A report of a medical diagnosis of bipolar disorder/mania
History of epilepsy
Diagnosed with cancer and/or on antifolate therapy
Have a diagnosis of dementia or Alzheimer’s disease
Are currently taking vitamin supplements containing folate, B2, B6 or B12 at a dose exceeding 25% of the recommended daily intake.
Medical contradictions to exercise (e.g., significant orthopaedic problems or cardiovascular disease that would prevent regular aerobic exercise)
Ongoing participation in regular aerobic exercise.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00214682

Contacts

Contact: Janine G Walker, BA (Hons), MA, PhD	061 2 6125 2741	janine.walker@anu.edu.au
Contact: Helen Christensen, BA (Hons) Mpsych, PhD, FASSA	0061 6125 8409	helen.christensen@anu.edu.au

Locations

Australia, Australian Capital Territory
Australian National University	Recruiting
Canberra, Australian Capital Territory, Australia, 0200

Sponsors and Collaborators

Australian National University

Australian Government Department of Health and Ageing

University of Sydney

University of Adelaide

Investigators

Principal Investigator:	Professor Helen Christensen, PhD	Centre for Mental Health Research, ANU
Principal Investigator:	Professor Anthony F Jorm, PhD	ORYGEN Research Centre, University of Melbourne
Principal Investigator:	Professor Ian Hickie, PhD	Brain and Mind Research Institute, University of Sydney
Principal Investigator:	Dr Michael Fenech, PhD	CSIRO Division of Human Nutrition, Adelaide

More Information

The Beyond Ageing Project This link exits the ClinicalTrials.gov site

Study ID Numbers:	2004/188 HREC, 2005/483 (TGA)
Study First Received:	September 14, 2005
Last Updated:	August 1, 2006
ClinicalTrials.gov Identifier:	NCT00214682
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Australian National University:

Depression
Cognition
Depressive disorder
Mental health literacy

Study placed in the following topic categories:

Folic Acid
Depression
Mental Disorders
Hydroxocobalamin
Mood Disorders

Vitamin B 12
Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Vitamin B Complex
Growth Substances
Vitamins

Physiological Effects of Drugs
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009