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 Cognition	Drug: Folate (400mcg) and Vitamin B12 (100 mcg)  Behavior: Physical activity  Behavior: Mental health literacy (knowledge about mental health problems)

Further Study Details: 

Primary Outcomes: Depression [assessed at baseline, 6 weeks, 6 months, 12 months and 24 month follow-ups]
Secondary Outcomes: 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.
Expected Total Enrollment:  2000

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.

Ages Eligible for Study:  65 Years   -   74 Years,  Genders Eligible for Study:  Both

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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00214682

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

Study chairs or principal investigators

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

Study ID Numbers:  2004/188 HREC; 2005/483 (TGA)
Last Updated:  September 21, 2005
Record first received:  September 14, 2005
ClinicalTrials.gov Identifier:  NCT00214682
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration; Australia: Australian National University
ClinicalTrials.gov processed this record on 2005-09-27