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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Bipolar Disorders	Dietary Supplement: Omega-3 fatty acids (EPAX 6015 TG); Dietary Supplement: Corn oil	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	55 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Omega-3 Fatty Acids in Bipolar Patients With a Low Omega-3 Index and Reduced Heart Rate Variability: the "BIPO-3" Trial
Study Start Date :	April 2009
Actual Primary Completion Date :	June 2012
Actual Study Completion Date :	April 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Placebo Comparator: Corn oil	Dietary Supplement: Corn 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.
Experimental: Omega-3 fatty acids	Dietary Supplement: Omega-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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. SDNN (msec) [ Time Frame: at baseline and after 12 weeks ]

Secondary Outcome Measures :

1. LF/HF ratio [ Time Frame: at baseline and after 12 weeks ]
2. Time to new episode [ Time Frame: study period (12 weeks) ]
3. Mood Rating Scales [ Time Frame: at baseline and after 12 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Germany
Department of Psychiatry, University of Munich
Munich, Bavaria, Germany, 80336

Sponsors and Collaborators

Ludwig-Maximilians - University of Munich

Investigators

Principal Investigator:	Emanuel Severus, M.D.	Ludwig-Maximilians - University of Munich

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	W. Emanuel Severus, M.D., University Hospital Dresden
ClinicalTrials.gov Identifier:	NCT00891826 History of Changes
Other Study ID Numbers:	EPAX 103
First Posted:	May 1, 2009
Last Update Posted:	April 12, 2013
Last Verified:	April 2013

Keywords provided by W. Emanuel Severus, University Hospital Dresden:

Bipolar disorders; Omega-3 fatty acids; Heart rate

Additional relevant MeSH terms:

Bipolar Disorder; Bipolar and Related Disorders; Mental Disorders