ACTRN12610000032055
Active, not recruiting
Phase 3
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.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Sydney
- Enrollment
- 205
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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