Omega-3 Fatty Acids in Bipolar Patients With a Low Omega-3 Index and Reduced Heart Rate Variability
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ClinicalTrials.gov Identifier: NCT00891826 |
Recruitment Status
:
Completed
First Posted
: May 1, 2009
Last Update Posted
: April 12, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bipolar Disorders | Dietary Supplement: Omega-3 fatty acids (EPAX 6015 TG) Dietary Supplement: Corn oil | Not Applicable |
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 |

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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00891826
Germany | |
Department of Psychiatry, University of Munich | |
Munich, Bavaria, Germany, 80336 |
Principal Investigator: | Emanuel Severus, M.D. | Ludwig-Maximilians - University of Munich |
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 Key Record Dates |
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 |