Omega-3 Fatty Acids in Bipolar Patients With a Low Omega-3 Index and Reduced Heart Rate Variability
This study has been completed.
Sponsor:
Ludwig-Maximilians - University of Munich
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
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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:
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 (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00891826
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
| 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 Bipolar and Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on September 23, 2016