NCT00891826

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 1, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 12, 2013

Status Verified

April 1, 2013

Enrollment Period

3.2 years

First QC Date

April 28, 2009

Last Update Submit

April 11, 2013

Conditions

Bipolar Disorders

Keywords

Bipolar disordersOmega-3 fatty acidsHeart rate

Outcome Measures

Primary Outcomes (1)

  • SDNN (msec)

    at baseline and after 12 weeks

Secondary Outcomes (3)

  • LF/HF ratio

    at baseline and after 12 weeks

  • Time to new episode

    study period (12 weeks)

  • Mood Rating Scales

    at baseline and after 12 weeks

Study Arms (2)

Corn oil

PLACEBO COMPARATOR
Dietary Supplement: Corn oil

Omega-3 fatty acids

EXPERIMENTAL
Dietary Supplement: Omega-3 fatty acids (EPAX 6015 TG)

Interventions

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.

Omega-3 fatty acids
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.

Corn oil

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, University of Munich

Munich, Bavaria, 80336, Germany

Location

Related Publications (1)

  • 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.

    PMID: 35362878DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Fatty Acids, Omega-3Corn Oil

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsFats, UnsaturatedPlant OilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Emanuel Severus, M.D.

    Ludwig-Maximilians - University of Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

April 28, 2009

First Posted

May 1, 2009

Study Start

April 1, 2009

Primary Completion

June 1, 2012

Study Completion

April 1, 2013

Last Updated

April 12, 2013

Record last verified: 2013-04

Locations

DE(1)