Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000477325
Ethics application status
Approved
Date submitted
19/09/2008
Date registered
25/09/2008
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of fish oil for treatment of aggressive behaviour in young people
Scientific title
A randomised controlled trial of fish oil capsules compared to placebo capsules for the treatment of overt aggression in children and adolescents with disruptive behaviour disorders
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overt aggression associated with disruptive behaviour disorders 3719 0
Condition category
Condition code
Mental Health 3890 3890 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fish oil oral capsules - 4 grams fish oil daily, containing a total of 400mg Eicosapentaenoic Acid (EPA) and 2000mg Docosahexaenoic Acid (DHA), for 6 weeks continuous treatment
Intervention code [1] 3431 0
Treatment: Drugs
Comparator / control treatment
Identical placebo capsules
(4 grams low polyphenol olive oil daily, with trace amounts of fish oil to mask taste, oral capsules for 6 weeks continuous treatment)
Control group
Placebo

Outcomes
Primary outcome [1] 4789 0
Overt aggressive behaviour (Children's Aggression Scale)
Timepoint [1] 4789 0
At baseline and at 6 and 12 weeks after commencement of intervention
Primary outcome [2] 4790 0
Overt aggressive behaviour (Modified Overt Aggression Scale)
Timepoint [2] 4790 0
At baseline and weekly for 12 weeks after commencement of intervention
Secondary outcome [1] 8085 0
Family functioning (Family Assessment Device)
Timepoint [1] 8085 0
At baseline and at 6 and 12 weeks after commencement of intervention

Eligibility
Key inclusion criteria
1. Presence of overt aggressive behaviours
2. Diagnosis of one of the disruptive behaviour disorders (Oppositional Defiant Disorder or Conduct Disorder)
3. Under 18 years of age
Minimum age
6 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Over 17 years of age
2. Diagnosis of any of the following: autism or other developmental disorder; mental retardation; schizophrenia, bipolar disorder, posttraumatic stress disorder or substance use disorder

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/09/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3897 0
Hospital
Name [1] 3897 0
Queensland Health Health Practitioner Research Scheme
Country [1] 3897 0
Australia
Funding source category [2] 3898 0
Commercial sector/Industry
Name [2] 3898 0
Blackmores Australia
Country [2] 3898 0
Australia
Primary sponsor type
Hospital
Name
Mater Child & Youth Mental Health Service
Address
Kids in Mind Research
Mater Child & Youth Mental Health Service
Community Services Building, 39 Annerley Rd
South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 3499 0
None
Name [1] 3499 0
Address [1] 3499 0
Country [1] 3499 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 28954 0
Address 28954 0
Country 28954 0
Phone 28954 0
Fax 28954 0
Email 28954 0
Contact person for public queries
Name 12111 0
Kareen Adam
Address 12111 0
Kids in Mind Research
Mater Child & Youth Mental Health Service
Community Services Building, 39 Annerley Rd
South Brisbane QLD 4101
Country 12111 0
Australia
Phone 12111 0
61 7 3163 1823
Fax 12111 0
Email 12111 0
[email protected]
Contact person for scientific queries
Name 3039 0
Angela Dean
Address 3039 0
Kids in Mind Research
Mater Child & Youth Mental Health Service
Community Services Building, 39 Annerley Rd
South Brisbane QLD 4101
Country 3039 0
Australia
Phone 3039 0
61 7 3163 1007
Fax 3039 0
Email 3039 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.