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Trial registered on ANZCTR


Trial ID
ACTRN12612000405819
Ethics application status
Approved
Date submitted
5/04/2012
Date registered
11/04/2012
Date last updated
12/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Fish oil for mood stabilization during pregnancy in women with bipolar disorder
Scientific title
Long-chain omega-3 fatty acids for mood stabilization during pregnancy in women with bipolar disorder - A randomized controlled trial.
Secondary ID [1] 280143 0
Nil
Universal Trial Number (UTN)
U1111-1129-5796
Trial acronym
Stabil Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar disorder in pregnancy 286071 0
Condition category
Condition code
Mental Health 286266 286266 0 0
Other mental health disorders
Reproductive Health and Childbirth 286440 286440 0 0
Other reproductive health and childbirth disorders
Alternative and Complementary Medicine 286475 286475 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 284478 0
Prevention
Intervention code [2] 284650 0
Treatment: Other
Comparator / control treatment
The control group will receive: 1 g concentrated omega-3 triglycerides from fish (containing 430 mg docosahexaenoic acid and 90 mg eicosapentaenoic acid) plus 4 g medium chain fatty acids from coconut. Taken as an oral capsule once daily from enrollment (up to 10 weeks of pregnancy) till 12 weeks postpartum.

There will also be a comparator group who have chosen to maintain their mood stabiliser medication. These women will be automatically allocated standard dose fish oil. They will receive: 1 g concentrated omega-3 triglycerides from fish (containing 430 mg docosahexaenoic acid and 90 mg eicosapentaenoic acid) without additional placebo.
Taken as an oral capsule once daily from enrollment (up to 10 weeks of pregnancy) till 12 weeks postpartum.
Control group
Dose comparison

Outcomes
Primary outcome [1] 286733 0
Number of mood episode recurrences.
Mood episode recurrence will be defined by DSM-IV criteria for major depression, hypomania or mania, or the need for rescue medication to be provided by the treating clinician due to deteriorating mood.
Timepoint [1] 286733 0
From baseline to childbirth.
Secondary outcome [1] 296550 0
Time to onset of first mood episode recurrence.
Timepoint [1] 296550 0
From baseline to childbirth.
Secondary outcome [2] 296551 0
Severity of depressive and manic symptoms.
The Montgomery Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) will be used to assess the severity of mood symptoms.
Timepoint [2] 296551 0
Monthly follow-ups throughout pregnancy.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The holder of the allocation schedule will be an independent member of staff that is in no other way invovled in this study. The research assistant responsible for recruiting the participant will obtain the treatment allocation ('A' or 'B' - blinded) from the holder of the allocation schedule. Both of these parties are blinded as to the identity of treatments A and B.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated simple random number sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This study will also incorporate a 'comparator' group comprising participants who have chosen to maintain MS medication during pregnancy. These participants will be automatically assigned to receive Standard Omega-3 supplements.
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284898 0
Government body
Name [1] 284898 0
Department of Health and Aging, Canberra
Address [1] 284898 0
GPO Box 9848,
Canberra ACT 2601
Country [1] 284898 0
Australia
Primary sponsor type
University
Name
Univeristy of New South Wales
Address
Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 283904 0
Charities/Societies/Foundations
Name [1] 283904 0
Black Dog Institute
Address [1] 283904 0
Hosptial Road
Randwick NSW 2031
Country [1] 283904 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286893 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 286893 0
Ethics Secretariat
UNSW Grants Management Office
Rupert Myers Building, Level 3 (M15)
The University of New South Wales
Sydney, NSW 2052
Ethics committee country [1] 286893 0
Australia
Date submitted for ethics approval [1] 286893 0
Approval date [1] 286893 0
24/01/2012
Ethics approval number [1] 286893 0
HC11506

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33928 0
Address 33928 0
Country 33928 0
Phone 33928 0
Fax 33928 0
Email 33928 0
Contact person for public queries
Name 17175 0
Amelia Paterson
Address 17175 0
Black Dog Institute
Hospital Rd
Randwick, NSW
2031
Country 17175 0
Australia
Phone 17175 0
+61 02 9382 8509
Fax 17175 0
Email 17175 0
amelia.paterson@unsw.edu.au
Contact person for scientific queries
Name 8103 0
Dr Bronwyn Hegarty
Address 8103 0
Black Dog Institute
Hospital Rd
Randwick, NSW
2031
Country 8103 0
Australia
Phone 8103 0
+61 02 9382 3707
Fax 8103 0
Email 8103 0
b.hegarty@unsw.edu.au