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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
W. Emanuel Severus, University Hospital Dresden
ClinicalTrials.gov Identifier:
NCT00891826
First received: April 28, 2009
Last updated: April 11, 2013
Last verified: April 2013

April 28, 2009
April 11, 2013
April 2009
June 2012   (final data collection date for primary outcome measure)
SDNN (msec) [ Time Frame: at baseline and after 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00891826 on ClinicalTrials.gov Archive Site
  • LF/HF ratio [ Time Frame: at baseline and after 12 weeks ] [ Designated as safety issue: No ]
  • Time to new episode [ Time Frame: study period (12 weeks) ] [ Designated as safety issue: No ]
  • Mood Rating Scales [ Time Frame: at baseline and after 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Omega-3 Fatty Acids in Bipolar Patients With a Low Omega-3 Index and Reduced Heart Rate Variability
Omega-3 Fatty Acids in Bipolar Patients With a Low Omega-3 Index and Reduced Heart Rate Variability: the "BIPO-3" Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bipolar Disorders
  • 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.
  • 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.
  • Placebo Comparator: Corn oil
    Intervention: Dietary Supplement: Corn oil
  • Experimental: Omega-3 fatty acids
    Intervention: Dietary Supplement: Omega-3 fatty acids (EPAX 6015 TG)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
April 2013
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00891826
EPAX 103
Yes
W. Emanuel Severus, University Hospital Dresden
Ludwig-Maximilians - University of Munich
Not Provided
Principal Investigator: Emanuel Severus, M.D. Ludwig-Maximilians - University of Munich
Ludwig-Maximilians - University of Munich
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP