Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000440527
Ethics application status
Approved
Date submitted
6/10/2006
Date registered
12/10/2006
Date last updated
25/07/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Omega-3 fatty acids in the treatment of children and adolescents with bipolar disorder
Scientific title
An open-label study to evaluate the effects of omega-3 polyunsaturated fatty acids delivered in tuna oil in the treatment of children and adolescents with bipolar disorder to improve symptoms of mania and depression
Secondary ID [1] 310 0
University of Newcastle: Protocol Number UNEWCO601H
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar Affective Disorder 1412 0
Condition category
Condition code
Mental Health 1507 1507 0 0
Depression
Neurological 1508 1508 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Open-label treatment of children and adolescents with capsules containing omega-3 fatty acids.
Capsule details:
HiDHA ® 25F Soft Gel 1000 mg omega-3 fatty acid capsules made from tuna oil containing Eicosapentanoic acid (EPA) 6% and Docosahexaenoic acid (DHA) 26% manufactured by NuMega Ingredients Pty Ltd.
Dose: 6000 mg of tuna oil containing 360 mg EPA and 1560 mg DHA per day
Route of Administration: Oral.
Dose administration: 3 capsules bd (Total 6 capsules per day).
Duration of administration: 42 days.
Intervention code [1] 1392 0
Treatment: Other
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2085 0
Young Mania Rating Scale
Timepoint [1] 2085 0
At 6 weeks.
Secondary outcome [1] 3600 0
Hamilton Depression Rating Scale
Timepoint [1] 3600 0
6 weeks
Secondary outcome [2] 3601 0
Clinical Global Impressions scale
Timepoint [2] 3601 0
6 weeks

Eligibility
Key inclusion criteria
Meet diagnostic criteria for either BAD I, BAD II or BAD-NOS as specified in the DSM-IV-TR (APA, 2000).• Have had an episode of mania, hypomania, mixed mania or major depression in the preceding 6 months• Are currently being prescribed either a mood stabilising medication, an atypical antipsychotic medication or a combination of both medication groups. • Males and Females between 8-18 years at initial assessment.
Minimum age
8 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Primary medical or neurological cause of the mood disorder• Comorbid diagnosis of Autistic Spectrum Disorder or clinically evident mental retardation.• Comorbid diagnosis of a significant medical disorder, such as active hepatic or renal disease, dementia, serious head injury or active cancer.• Diagnosed with Non-Insulin Dependent Diabetes Mellitus (NIDDM) - type 2 diabetes.• Diagnosed with any cardiovascular, haematological or gastrointestinal disease.• Have taken fish oil (omega-3 fatty acids) as supplements within the previous 6 weeks. • Are receiving any concomitant medications that affect lipid metabolism, such as HMG-CoA inhibitors or high-dose niacin.• Patients receiving drugs which affect blood coagulation due to the theoretical risk of bleeding during LC n-3 fa supplementation.• Are pregnant.• Have a body mass index (BMI) less than 16 or greater than 30.• Actively consuming a low fat diet.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/10/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1644 0
Government body
Name [1] 1644 0
Hunter New England area Health Service NuMega Ingredients
Country [1] 1644 0
Australia
Primary sponsor type
Individual
Name
Professor Philip Hazell
Address
Hospital Road
Concord West NSW
Country
Australia
Secondary sponsor category [1] 1452 0
None
Name [1] 1452 0
Nil
Address [1] 1452 0
Country [1] 1452 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3093 0
The Bipolar Program, Hunter New England Area Health Service
Ethics committee address [1] 3093 0
Ethics committee country [1] 3093 0
Australia
Date submitted for ethics approval [1] 3093 0
Approval date [1] 3093 0
11/09/2006
Ethics approval number [1] 3093 0
06/06/23/5.06

Summary
Brief summary
Purpose of the Study: To assess the effect of omega-3 fatty acids on symptoms of mania and depression in children and adolescents with bipolar disorder.
Hypothesis: Supplementation with omega-3 capsules will improve symptoms of mania as measured by the Young Mania Rating Scale and symptoms of depression as measured by the Hamilton Rating Scale for Depression in children and adolescents with bipolar disorder.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27619 0
Address 27619 0
Country 27619 0
Phone 27619 0
Fax 27619 0
Email 27619 0
Contact person for public queries
Name 10581 0
Dr Edward Clayton
Address 10581 0
Nutraceuticals Research Group - University of Newcastle
Medical Sciences Building
Room 305B
University of Newcastle Callaghan
NSW 2308
Country 10581 0
Australia
Phone 10581 0
+61 2 49215343
Fax 10581 0
Email 10581 0
[email protected]
Contact person for scientific queries
Name 1509 0
Dr Edward Clayton
Address 1509 0
Nutraceuticals Research Group - University of Newcastle
Medical Sciences Building
Room 305B
University of Newcastle Callaghan
NSW 2308
Country 1509 0
Australia
Phone 1509 0
+61 2 49215343
Fax 1509 0
Email 1509 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.