Bipolar DisordersNCT00891826
Omega-3 Fatty Acids in Bipolar Patients With a Low Omega-3 Index and Reduced Heart Rate Variability
A study testing Omega-3 fatty acids (EPAX 6015 TG) and Corn oil in people with Bipolar Disorders, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorders
- What is being tested?
- Omega-3 fatty acids (EPAX 6015 TG) and Corn oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2009to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry, University of Munich
Munich, Bavaria, 80336
About this study
Official title: 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.
- Conditions
- Bipolar Disorders
- Being tested
- Omega-3 fatty acids (EPAX 6015 TG), Corn oil
- Keywords
- Bipolar disorders, Omega-3 fatty acids, Heart rate
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 oilDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Corn oil | Placebo comparator | Not described Receives: Dietary Supplement: Corn oil |
| Omega-3 fatty acids | Experimental | Not described Receives: Dietary Supplement: Omega-3 fatty acids (EPAX 6015 TG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SDNN (msec)
Measured: at baseline and after 12 weeks
Secondary outcomes (3)
LF/HF ratio
Measured: at baseline and after 12 weeks
Time to new episode
Measured: study period (12 weeks)
Mood Rating Scales
Measured: at baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, W. Emanuel Severus, University Hospital Dresden
- Investigators
- Emanuel Severus, M.D., Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891826
- Sponsor's protocol ID
- EPAX 103
- Status last verified
- Apr 2013
- First submitted
- 28 Apr 2009
- Last updated
- 12 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acids in Bipolar Patients With a Low Omega-3 Index and Reduced Heart Rate Variability: the "BIPO-3" Trial
- ClinicalTrials.gov ID
- NCT00891826
- Acronym / sponsor ID
- EPAX 103
- Conditions
- Bipolar Disorders
- Keywords
- Bipolar disorders, Omega-3 fatty acids, Heart rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 1 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corn oil | Placebo comparator | Dietary Supplement: Corn oil |
| Omega-3 fatty acids | Experimental | Dietary Supplement: Omega-3 fatty acids (EPAX 6015 TG) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Omega-3 fatty acids |
| Corn oilThe 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. | Dietary supplement | Corn oil |
Primary outcome
SDNN (msec)
Time frame: at baseline and after 12 weeks
3 secondary outcomes
LF/HF ratio
Time frame: at baseline and after 12 weeks
Time to new episode
Time frame: study period (12 weeks)
Mood Rating Scales
Time frame: at baseline and after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2013.
- Derived from this study: PubMed 35362878Berger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emanuel Severus, M.D. principal investigator
Ludwig-Maximilians - University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 fatty acids (EPAX 6015 TG) and Corn oil in people with Bipolar Disorders, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SDNN (msec) (time frame: at baseline and after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00891826, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2013.