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CompletedNCT00891826Updated Apr 12, 2013

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

An interventional study of Omega-3 fatty acids (EPAX 6015 TG) and Corn oil in Bipolar Disorders, sponsored by Ludwig-Maximilians - University of Munich. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-04-12.

Sponsored by Ludwig-Maximilians - University of Munich · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Bipolar Disorders

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Keywords

  • Bipolar disorders
  • Omega-3 fatty acids
  • Heart rate
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In context

Bipolar Disorder

1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.

This study's enrollment of 55 is below the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.

Browse Bipolar Disorder studies →

Lead sponsor

Ludwig-Maximilians - University of Munich is the lead sponsor of 218 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
55 participants (actual)

Study arms

  • Placebo comparator
    Corn oil

    Dietary Supplement: Corn oil

  • Experimental
    Omega-3 fatty acids

    Dietary Supplement: Omega-3 fatty acids (EPAX 6015 TG)

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.

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What researchers measure

Primary outcomes

  1. SDNN (msec)

    Time frame: at baseline and after 12 weeks

Secondary outcomes

  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

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Study locations

1 site
  • Department of Psychiatry, University of Munich
    Munich, Bavaria 80336, Germany
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References and documents

Publications

  • Berger M, Seemuller F, Voggt A, Obermeier M, Kirchberg F, Low A, Riedel M, von Schacky C, Severus E. Omega-3 fatty acids in bipolar patients with a low omega-3 index and reduced heart rate variability: the "BIPO-3" trial. Int J Bipolar Disord. 2022 Apr 1;10(1):9. doi: 10.1186/s40345-022-00253-9. PubMed 35362878 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00891826
Lead sponsor
Ludwig-Maximilians - University of Munich
Responsible party
W. Emanuel Severus (M.D., University Hospital Dresden) — Principal investigator
First posted
May 1, 2009
Start date
Apr 2009
Primary completion
Jun 2012
Completion
Apr 2013
Last update
Apr 12, 2013

Study contacts

Emanuel Severus, M.D.
principal investigator · Ludwig-Maximilians - University of Munich

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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