Bipolar Disorders
Conditions
Keywords
Bipolar disorders, Omega-3 fatty acids, Heart rate
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 euthymic bipolar patients with a low omega-3 index and reduced heart rate variability.
Interventions
DIETARY_SUPPLEMENTOmega-3 fatty acids (EPAX 6015 TG)
The study drug is a food supplement called EPAX 6015 TG. One capsule of EPAX 6015 TG contains 530 mg of EPA (eicosapentaenoic acid) and 150 mg of DHA (docosahexaenoic acid), provided as triglycerides. For the entire study period (12 weeks) patients will receive 4 capsules of EPAX 6015 TG per day.
DIETARY_SUPPLEMENTCorn oil
The corn oil capsules look exactly the same as the capsules containing omega-3 fatty acids. For the entire study period patients will receive 4 capsules of corn oil per day.
Sponsors
Ludwig-Maximilians - University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects must meet the DSM-IV criteria for bipolar disorders, in remission 2. Age: 18 - 65 years 3. Low omega-3 index (\<5%) 4. SDNN \< 60 msec 5. Subjects must have adequate fluency in German or English to complete baseline and follow-up interviews and fill out the Beck Depression Inventory 6. Stable psychotropic medication for at least 2 weeks 7. Subjects must be able to give written informed consent
Exclusion criteria
1. Subjects for whom the intake of omega-3 fatty acids is indicated according to recent treatment guidelines 2. Patients on Warfarin 3. Subjects with any acute and life-threatening condition, such as collapse and shock, acute myocardial infarction, stroke, embolism 4. Subjects with significant medical comorbidity 5. 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 6. 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 7. Subjects fulfilling the DSM-IV diagnostic criteria for current substance abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SDNN (msec) | at baseline and after 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| LF/HF ratio | at baseline and after 12 weeks |
| Time to new episode | study period (12 weeks) |
| Mood Rating Scales | at baseline and after 12 weeks |
Countries
Germany
Outcome results
None listed