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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
History of Changes
  Purpose

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 Intervention
Bipolar Disorders
 Dietary Supplement: Omega-3 fatty acids (EPAX 6015 TG)
Dietary Supplement: Corn oil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • SDNN (msec) [ Time Frame: at baseline and after 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 55
Study Start Date: April 2009
Study Completion Date: April 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00891826

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

No publications provided

Responsible Party: W. Emanuel Severus, M.D., University Hospital Dresden
ClinicalTrials.gov Identifier: NCT00891826     History of Changes
Other Study ID Numbers: EPAX 103
Study First Received: April 28, 2009
Last Updated: April 11, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Ludwig-Maximilians - University of Munich:
Bipolar disorders
Omega-3 fatty acids
Heart rate

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013