Status:
COMPLETED
Omega-3 Fatty Acids in Bipolar Patients With a Low Omega-3 Index and Reduced Heart Rate Variability
Lead Sponsor:
Ludwig-Maximilians - University of Munich
Conditions:
Bipolar Disorders
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This study sets out to test the hypothesis that parameters of heart rate variability, as a non-invasive measure of cardiovascular risk, can be improved by the addition of omega-3 fatty acids in euthym...
Eligibility Criteria
Inclusion
- Subjects must meet the DSM-IV criteria for bipolar disorders, in remission
- Age: 18 - 65 years
- Low omega-3 index (\<5%)
- SDNN \< 60 msec
- Subjects must have adequate fluency in German or English to complete baseline and follow-up interviews and fill out the Beck Depression Inventory
- Stable psychotropic medication for at least 2 weeks
- Subjects must be able to give written informed consent
Exclusion
- Subjects for whom the intake of omega-3 fatty acids is indicated according to recent treatment guidelines
- Patients on Warfarin
- Subjects with any acute and life-threatening condition, such as collapse and shock, acute myocardial infarction, stroke, embolism
- Subjects with significant medical comorbidity
- Pregnant subjects - due to any possible teratogenic effects of EPAX 6015 TG and corn oil, respectively, on the fetus - and breastfeeding subjects. In addition, women of childbearing potential who will not practice a medically accepted method of contraception will be excluded
- Subjects who, in the investigator's judgement, pose a current significant suicidal or homicidal risk or patients who will not likely be able to comply with the study protocol
- Subjects fulfilling the DSM-IV diagnostic criteria for current substance abuse
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00891826
Start Date
April 1 2009
End Date
April 1 2013
Last Update
April 12 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Psychiatry, University of Munich
Munich, Bavaria, Germany, 80336