Beyond Ageing Project: A Study for the Prevention of Depression

What Was Tested

In this phase 2 trial, researchers set out to test Cyanocobalamin (Vitamin B12).

It had six arms (groups): one (experimental), Mediated physical activity promotion (experimental), one (experimental), Placebo tablet (placebo comparator) and Nutrition information (active comparator).

The registry classes the interventions as behavioral and drug.

More on the Plan

Participants will receive these interventions over a two-year period with regular assessments across that time period.

Who Took Part

The registry lists 909 actual participants took part.

It was open to people of any sex aged from 65 years up to 74 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Aged 65-74 years with some depressive symptoms, assessed using the Kessler 10 Psychological Distress Scale \[K10\] (Andrews \& Slade, 2001).

The full record lists 1 inclusion and 8 exclusion criteria; among the exclusions: those currently taking medication or receiving psychological treatment for depression; A report of a medical diagnosis of bipolar disorder/mania; history of epilepsy.

How the Study Was Run

It was run as a randomized, factorial and triple-blind study.

Because people in this Cyanocobalamin (Vitamin B12) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Blinding on both sides kept the participants and researchers unaware of who received Cyanocobalamin (Vitamin B12).

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2005-10 with completion listed for 2011-01.

It ran at 1 site in Australia.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Depression (time frame: Baseline, 6 weeks, 6-, 12-, 48-, and 51 month followups).

It also tracked 6 secondary outcomes, for example Physical activity level, Cognitive impairment, B12 levels, Folate status and Homocysteine.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Cyanocobalamin (Vitamin B12) in 909 people.

With 909 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.