None listed
Conditions
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.
Interventions
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
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.
Sponsors
Professor Philip Hazell
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
8 Years to 18 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed