None listed
Conditions
Brief summary
People with bipolar disorder (BD) experience recurrent, extreme highs and lows in mood, which can severely affect their health, career and relationships. BD can often be effectively treated with long-term mood stabilizer (MS) medications. Unfortunately though, MS medications can cause birth defects and complications if taken during pregnancy. If women with BD stop taking MS medications during pregnancy however, they run a very high risk of relapse, and unstable maternal mental health during pregnancy is associated with poor outcomes for both mother and child. In this study, we aim to determine if a natural dietary supplement (omega-3 fatty acids), which is safe for both mother and baby, has the potential to offer women with bipolar disorder an effective alternative to MS medication during pregnancy. Long-chain omega-3 fatty acids (LC-omega-3 FA) comprise a family of essential nutrients which have a variety of vital actions in the body. In particular, LC-omega-3 FA have important effects on brain development and function. Recent studies indicate that LC-omega-3 FA supplementation can affect mood, particularly to reduce depression. In this project, we will undertake a clinical trial to evaluate the efficacy of LC-omega-3 FA supplementation to reduce the occurrence of mood episodes in bipolar women who discontinue their use of MS medication during pregnancy.
Interventions
5 g concentrated omega-3 triglycerides from fish (containing 1000mg docosahexaenoic acid and 1500mg eicosapentaenoic acid)
Taken as an oral capsule once daily from enrollment (up to 10 weeks of pregnancy) till 12 weeks postpartum.
Sponsors
Univeristy of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Pregnant women (up to 10 weeks of pregnancy). 2. Must have a clinical diagnosis of Bipolar Disorder I or II. 3. Must be using MS medication with an intention to either continue or discontinue MS medication throughout pregnancy (for entry into comparator and experimental groups respectively). 4. Must not have experienced a mood episode reaching DSM IV-TR criteria within 4 weeks of recruitment. 5. Must be prepared to continue regular visits to their personal treating medical professional/s throughout study period for ongoing psychiatric and antenatal care. 6. Must be able to give written informed consent.
Exclusion criteria
1. Under 18 years of age. 2. Poor written and/or spoken English. 3. Diagnosed with schizophrenia or schizoaffective disorder. 4. Taking any daily supplement containing more than 120 mg EPA or more than 500mg EPA + DHA. 5. At high risk of suicide. 6. Participating in another clinical trial. 7. Current drug or alcohol problems. 8. Unstable medical condition, unstable thyroid dysfunction, lipid metabolism disorder. 9. Current use of anticoagulant therapy. 10. Have a bleeding disorder. 11. Fish/seafood allergy.
Outcome results
None listed