Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000032055
Ethics application status
Approved
Date submitted
22/10/2009
Date registered
12/01/2010
Date last updated
8/02/2019
Date data sharing statement initially provided
22/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Beyond Ageing Project: A selective prevention trial using novel pharmacotherapies in an older age cohort at risk for depression
Scientific title
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.
Secondary ID [1] 263013 0
Clinical Trial Notification (CTN) Scheme Trial Number: 2011/0309
Universal Trial Number (UTN)
U1111-1124-4580
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 243594 0
cognitive decline 243595 0
Condition category
Condition code
Mental Health 239877 239877 0 0
Depression
Mental Health 239878 239878 0 0
Studies of normal psychology, cognitive function and behaviour
Diet and Nutrition 252074 252074 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 241182 0
Prevention
Comparator / control treatment
The participants in the placebo condition will take: four placebo capsules (paraffin oil and small amount of fish oil to disguise taste) and one placebo tablet (microcrystalline cellulose).
Control group
Placebo

Outcomes
Primary outcome [1] 240753 0
Mean change in severity of depression symptoms as measured by scores on the PHQ-9 from baseline to 12 months.
Timepoint [1] 240753 0
Baseline, 3-months, and 12-months.
Secondary outcome [1] 257411 0
Depressive symptoms as measured by a 20% reduction on the K-10 over a 12-month period.
Timepoint [1] 257411 0
Baseline, 3 and 12 months
Secondary outcome [2] 257413 0
Difference in proportion of participants in each intervention arm classed as being asymptomatic for depression at 12 months. ‘Depression’ will be defined by caseness, as evidenced by a score equal to or greater than 10 on the PHQ-9.
Timepoint [2] 257413 0
Baseline, 3 and 12 months
Secondary outcome [3] 257414 0
Change in cognitive function as measured by neuropsychological testing battery (comprising of WTAR, RAVLT, COWAT, Boston Naming Test, Trails A & B, Clock Drawing Test, DKEFS Colour Word Interference Test, CANTAB PAL, and CANTAB RTI).
Timepoint [3] 257414 0
Baseline, 3 and 12 months
Secondary outcome [4] 257415 0
Performance on neuropsychological tests of: Processing speed (Cambridge Neuropsychological Test Automated Battery (CANTAB) Reaction Time, Trail Making Test, Part A); Memory (CANTAB Paired Associate Learning, Rey Auditory Verbal Learning Test (RAVLT)); and Executive Functioning (Trail Making Test Part B, Controlled Oral Word Associate Test (COWAT), DKEFS Colour Word Interference Test).
Timepoint [4] 257415 0
Baseline, 3 and 12 months
Secondary outcome [5] 257416 0
Self-reported levels of anxiety (GAD-7, GAI).
Timepoint [5] 257416 0
Baseline, 3 and 12 months
Secondary outcome [6] 257419 0
Composite Arterial Stiffness and Central Aortic Pressure measured by sphygmometer at baseline, 3 and 12-months.
Timepoint [6] 257419 0
Baseline, 3 and 12 months
Secondary outcome [7] 325046 0
Composite Premorbid IQ estimates (Wechsler Test of Adult Reading) and scores on the Mini-Mental State Examination at baseline and 12-months, as well as an assessment of naming ability (Boston Naming Test) at baseline, 3 and 12-months.
Timepoint [7] 325046 0
Baseline, 3 and 12 months
Secondary outcome [8] 366037 0
Exploratory MRI-determined brain neurometabolites and volume changes after 3 months.
Timepoint [8] 366037 0
Baseline, 3 and 12 months
Secondary outcome [9] 366038 0
Self-reported levels of disability (WHODAS-II),
Timepoint [9] 366038 0
Baseline, 3 and 12 months
Secondary outcome [10] 366039 0
Self-reported levels of sleep (PSQI, actigraphy),
Timepoint [10] 366039 0
Baseline, 3 and 12 months
Secondary outcome [11] 366040 0
Self-reported levels of exercise (IPAQ),
Timepoint [11] 366040 0
Baseline, 3 and 12 months
Secondary outcome [12] 366041 0
Composite Self-reported levels of health and lifestyle factors (including diet, pain, and fatigue) as described by treatment group overall, and at 3 and 12 months, This will be measured by way of related questionnaire items and subsets within the K10 and PHQ9, side effects checklist, pain checklist, 3-Day Food Diary, and structured clinician medical interview.
Timepoint [12] 366041 0
Baseline, 3 and 12 months

Eligibility
Key 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.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will originally be recruited, via mail, through the Australian Electoral Commission, as per previous methods. Those who consent to participate will complete the initial eligibility screening interview over the telephone to identify any current depressive symptoms, as measured by the Patient Health Questionnaire (PHQ-9). Once telephone screening is complete, all participants will undergo a medical examination with a trial physician. As recruitment occurs, the allocation of treatment to participants will be administered independently of personnel in day-to-day contact with participants through an Interactive Voice Response System (IVRS) managed by the NHMRC Clinical Trials Centre. As recruitment occurs, a member of the Beyond Ageing Project Team will call the IVRS to carry out the random allocation. Each individual will be randomly assigned a value of 1 to 3, corresponding to one of the intervention arms, using the IVRS. The allocation of intervention arms to each numerical value will be documented by the NHMRC Clinical Trials Centre, not to be revealed until the completion of the trial unless un-blinding is required in an emergency.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Our randomization procedure is based on variable length blocks and is administered independently of personnel in day-to-day contact with participants.

Stratification will be according to sex, region and presenting depression severity (score on the K10). The last factor is used to ensure that the 'tail' of participants with higher levels of symptoms is distributed equally across conditions.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
The two different medication types are quite different in appearance, hence to ensure participants are blind to the treatment they are receiving, we are using two placebos. Participants will take two different medication types each day. Either: Four omega-3 capsules and one placebo (microcrystalline cellulose) tablet or; one sertraline hydrochloride tablet and four placebo (oil) capsules or; four placebo (oil) capsules and one placebo (microcrystalline cellulose) tablet.
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
18/07/2011
Actual
21/06/2011
Date of last participant enrolment
Anticipated
Actual
15/11/2017
Date of last data collection
Anticipated
31/01/2019
Actual
Sample size
Target
450
Accrual to date
Final
205
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 243776 0
University
Name [1] 243776 0
Brain and Mind Centre, University of Sydney
Country [1] 243776 0
Australia
Funding source category [2] 269819 0
Charities/Societies/Foundations
Name [2] 269819 0
Bupa Health Foundation
Country [2] 269819 0
Australia
Funding source category [3] 293896 0
Government body
Name [3] 293896 0
National Health and Medical Research Council
Country [3] 293896 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 237134 0
None
Name [1] 237134 0
NA
Address [1] 237134 0
NA
Country [1] 237134 0
Other collaborator category [1] 840 0
University
Name [1] 840 0
Centre for Mental Health Research, The Australian National University (ANU)
Address [1] 840 0
Beyond Ageing Project
Centre for Mental Health Research
School of Health & Psychological Sciences
ANU College of Medicine, Biology & Environment

Building 63, Eggleston Road
The Australian National University
Canberra ACT 0200
Country [1] 840 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243910 0
University of Sydney Human Research Ethics Committee (HREC)
Ethics committee address [1] 243910 0
Level 6
Jane Foss Russell Building G02
The University of Sydney
NSW 2006 AUSTRALIA
Ethics committee country [1] 243910 0
Australia
Date submitted for ethics approval [1] 243910 0
11/08/2009
Approval date [1] 243910 0
11/12/2009
Ethics approval number [1] 243910 0
2012/1630
Ethics committee name [2] 244023 0
The Australian National University HREC
Ethics committee address [2] 244023 0
Research Office
The Australian National University
Chancelry Building 10B LG
East Road
Acton ACT 0200
Ethics committee country [2] 244023 0
Australia
Date submitted for ethics approval [2] 244023 0
18/11/2009
Approval date [2] 244023 0
05/01/2010
Ethics approval number [2] 244023 0
2008/0188

Summary
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.
Trial website
http://cmhr.anu.edu.au/beyond_ageing.php
Trial related presentations / publications
Cockayne, N. L., Duffy, S. L., Bonomally, R., English, A., Amminger, P. G., Mackinnon, A., ... & Hickie, I. B. (2015). The Beyond Ageing Project Phase 2-a double-blind, selective prevention, randomised, placebo-controlled trial of omega-3 fatty acids and sertraline in an older age cohort at risk for depression: study protocol for a randomized controlled trial. Trials, 16(1), 1.
Public notes

Contacts
Principal investigator
Name 30092 0
Prof Ian Hickie
Address 30092 0
Beyond Ageing Project, Brain and Mind Centre, 94 Mallett Street Camperdown, NSW, 2050
Country 30092 0
Australia
Phone 30092 0
+621 9351 0810
Fax 30092 0
Email 30092 0
[email protected]
Contact person for public queries
Name 13339 0
Stacey West
Address 13339 0
Beyond Ageing Project, Brain and Mind Centre, 94 Mallett Street Camperdown, NSW, 2050
Country 13339 0
Australia
Phone 13339 0
+612 9114 4213
Fax 13339 0
+612 9351 0551
Email 13339 0
[email protected]
Contact person for scientific queries
Name 4267 0
Sharon Naismith
Address 4267 0
Beyond Ageing Project, Brain and Mind Centre, 94 Mallett Street Camperdown, NSW, 2050
Country 4267 0
Australia
Phone 4267 0
+61 2 9351 0781
Fax 4267 0
+612 9351 0551
Email 4267 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to data-handling procedures of the sponsor, the decision will be made upon request and at the Principal Investigator's discretion.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe beyond ageing project phase 2 - a double-blind, selective prevention, randomised, placebo-controlled trial of omega-3 fatty acids and sertraline in an older age cohort at risk for depression: Study protocol for a randomized controlled trial.2015https://dx.doi.org/10.1186/s13063-015-0762-6
N.B. These documents automatically identified may not have been verified by the study sponsor.