Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000390684
Ethics application status
Approved
Date submitted
21/03/2014
Date registered
10/04/2014
Date last updated
7/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Fish oil in chronic psychiatric outpatients with anxiety and mood disorders.
Scientific title
Adjunctive natural low dose docosahexaenoic acid (DHA) omega-3 in a 16 week random double-blind placebo controlled (RDBPC) cross-over withdrawal study in a group of chronic, psychiatric out-patients with anxiety and mood disorders.
Secondary ID [1] 284102 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic anxiety and mood disorders 291178 0
Condition category
Condition code
Mental Health 291516 291516 0 0
Anxiety
Mental Health 291517 291517 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Natural low dose docosahexaenoic acid (DHA) omega-3
(NeuroSpark) 130-390mg per day in addition to standard psychiatric treatments.

The dose in the study is the dose which has been found clinically to be appropriate and efficacious for each individual entering the study.

Oral.

This study medication will be administered for 16 weeks (24 week study minus 8 weeks on placebo = 16 weeks of study medication).

There is no washout period.

Adherence to study medication regimen will be monitored via capsule return and self-report daily diary entries.
Intervention code [1] 288797 0
Treatment: Other
Comparator / control treatment
Placebo - safflower oil capsules.
Control group
Placebo

Outcomes
Primary outcome [1] 291487 0
Measure the effectiveness of the DHA omega-3 versus placebo on neurocognitive and psychiatric symptoms.

This will be measured by the following scales: Hamilton Anxiety Scale (HAM-A), Hamilton Depression Scale (HAM-D), Leeds Sleep Evaluation, Fatigue questionnaire.

In addition, patients will complete the following scales: Depression, Anxiety and Stress Scale (DASS), Visual Analogue tracking of short-term memory, concentration, clarity of thinking, anxiety, mood swings/irritability, energy depression and sleep.
Timepoint [1] 291487 0
At the conclusion of the study (at 24 weeks).
Secondary outcome [1] 306886 0
Change from baseline in cognitive function using COMPASS cognitive testing in the areas of attention, immediate recall, spatial working memory and executive functioning.
Timepoint [1] 306886 0
At each study visit, at weeks 0, 4, 12, 20 and 24.
Secondary outcome [2] 306953 0
Levels of metabolites of Arachidonic acid (AA); cytokines (e.g. TNF-alpha and others), inflammatory markers (CRP), erythrocyte membrane polyunsaturated fatty acid (PUFA) analyses to measure PUFA levels.
Timepoint [2] 306953 0
Weeks 4, 12, 20.

Eligibility
Key inclusion criteria
1. Outpatients with chronic anxiety and/or depressive symptoms.
2. Patients currently taking DHA (NeuroSpark) capsules for at least 3 months prior to study entry.

Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. ADHD
2. Brain injury
3. Mild cognitive impairment
4. Dementias
5. Substance dependence and/or abuse
6. Schizophrenia
7. Acutely suicidal patients
8. Chronic unstable medical conditions

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following the open label phase (first 4 weeks of the study) there will be 2 double-blind crossover phases, each of 8 weeks duration, where the participant will first take DHA omega-3 then lookalike placebo capsule containing safflower oil, or placebo then DHA omega-3. In the final 4 weeks phase all participants receive DHA omega-3.

The procedure used for allocating the treatment will be by numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Methods used to generate the sequence for randomisation will be done by simple randomisation, using a randomisation table from a statistic book.
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
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a small scale pilot study in a clinical setting.
The study results will be analysed by mixed models repeated measures analysis of variance (ANOVA).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2014
Actual
Date of last participant enrolment
Anticipated
5/02/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 7780 0
3123 - Hawthorn East

Funding & Sponsors
Funding source category [1] 288931 0
Self funded/Unfunded
Name [1] 288931 0
Country [1] 288931 0
Primary sponsor type
Individual
Name
Dr Michael Piperoglou
Address
Private Consulting Rooms, 790 Burwood Road, Hawthorn East VIC 3123
Country
Australia
Secondary sponsor category [1] 287432 0
None
Name [1] 287432 0
Address [1] 287432 0
Country [1] 287432 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290570 0
The Melbourne Clinic Research Ethics Committee
Ethics committee address [1] 290570 0
Ethics committee country [1] 290570 0
Australia
Date submitted for ethics approval [1] 290570 0
Approval date [1] 290570 0
11/12/2013
Ethics approval number [1] 290570 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46274 0
Dr Michael Piperoglou
Address 46274 0
Private practitioner in specialist psychiatric practice at 790 Burwood Road, Hawthorn East VIC 3123

Masters student at University of Melbourne, Dept of Psychiatry
Country 46274 0
Australia
Phone 46274 0
+61 3 9813 1144
Fax 46274 0
+61 3 9882 0866
Email 46274 0
[email protected]
Contact person for public queries
Name 46275 0
Michael Piperoglou
Address 46275 0
Private practitioner in specialist psychiatric practice at 790 Burwood Road, Hawthorn East VIC 3123

Masters student at University of Melbourne, Dept of Psychiatry
Country 46275 0
Australia
Phone 46275 0
+61 3 9813 1144
Fax 46275 0
Email 46275 0
[email protected]
Contact person for scientific queries
Name 46276 0
Michael Piperoglou
Address 46276 0
Private practitioner in specialist psychiatric practice at 790 Burwood Road, Hawthorn East VIC 3123

Masters student at University of Melbourne, Dept of Psychiatry
Country 46276 0
Australia
Phone 46276 0
+61 3 9813 1144
Fax 46276 0
Email 46276 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Completed data cleaning and statistical analysis

Documents added automatically
No additional documents have been identified.