Omega-3 Fatty Acids in Bipolar Patients With a Low Omega-3 Index and Reduced Heart Rate Variability

Study Overview
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Brief Summary
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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.

Official Title
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Omega-3 Fatty Acids in Bipolar Patients With a Low Omega-3 Index and Reduced Heart Rate Variability: the BIPO-3 Trial

Conditions
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Bipolar Disorders

Intervention / Treatment
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* Dietary Supplement: Omega-3 fatty acids (EPAX 6015 TG)
* Dietary Supplement: Corn oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Corn oil<br> | Dietary Supplement: Corn oil<br>* 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.<br>|
| Experimental: Omega-3 fatty acids<br> | Dietary Supplement: Omega-3 fatty acids (EPAX 6015 TG)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SDNN (msec) |  | at baseline and after 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar disorders, Omega-3 fatty acids, Heart rate