The Beyond Ageing Project: A selective prevention trial using novel pharmacotherapies in an older age cohort at risk for depression

In older adults (60+ years) at risk for depression, can sertraline and/or omega-3 fatty acids compared with a placebo, reduce or prevent depressive symptoms, incidence of new cases of depression and/or cognitive decline.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000032055

Enrollment

205

Registered

2010-01-12

Start date

2011-06-21

Completion date

2017-11-15

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will investigate whether two interventions; omega-3 fatty acids supplements (fish oil) and the antidepressant, sertraline, are able to reduce or prevent depression and cognitive change. The study will run over 12 months and participants will be randomly allocated to one of the interventions or to a placebo condition. Participants will be assessed at different time points by telephone interviews, self report surveys, medical examinations and brief psychological assessments. These assessments will look at the effectiveness of the two interventions in reducing symptoms of depression and/or new cases of depression and reducing cognitive decline (e.g. changes in memory, concentration and thinking) associated with ageing. Additionally, because depression is believed to have a biological basis and because both these interventions influence brain activity, participants will also be invited to have three brain scans over the time of the study. We hope to track the effects of fish oil and sertraline on the brain changes associated with the normal ageing.

Interventions

In this 12 month, double-blind, randomised, placebo controlled prevention trial participants will be allocated to one of the following interventions in which they will receive a daily oral dose: 1) Four omega-3 fatty acid capsules (2g in total: Eicosapentaenoic acid (EPA) 1200mg and Docosahexaenoic acid (DHA) 800mg) and one placebo tablet (microcrystalline cellulose) or 2) One sertraline hydrochloride 50mg tablet and four placebo capsules (paraffin oil).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

60 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

To be eligible participants must: - Have provided written informed consent before any trial procedures are undertaken - Be aged 60 years or older, and - have a lifetime history of depressive symptoms (defined as a K-10 score ranging from 16 to 29) meaning that participants included in the trial will be at greater risk of depression.

Exclusion criteria

Participants will be excluded if they: - Have a history of stroke/other serious cerebro or cardiovascular illness, neurological, psychiatric or neurodegenerative disease or other significant illness; Show clinically relevant levels of depression on the Patient Health Questionnaire (PHQ-9) at the time of screening or, receive a diagnosis of depression based on the Structured Clinical Interview for DSM-IV-TR Axis I Disorders (SCID-I) at the time of completing the medical assessment; Are suicidal at the time of screening or at the time of completing the medical assessment; Show abnormal liver function or; Are currently taking anti-depressant medications and it is deemed unadvisable by the trial psychiatrist to cease these medications for the period of the trial.

Outcome results