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Completed

NCT Number: NCT00891826

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

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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Key information

Conditions

Bipolar Disorders Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry, University of Munich

Munich, Bavaria, 80336, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3 fatty acids (EPAX 6015 TG)

Dietary Supplement

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.

corn oil

Dietary Supplement

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.

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

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
May 1, 2009
Registry last updated
Apr 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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