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

Primary Purpose

Bipolar Disorders

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Omega-3 fatty acids (EPAX 6015 TG)
Corn oil
Sponsored by
Ludwig-Maximilians - University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorders focused on measuring Bipolar disorders, Omega-3 fatty acids, Heart rate

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychiatry, University of Munich

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Corn oil

Omega-3 fatty acids

Arm Description

Outcomes

Primary Outcome Measures

SDNN (msec)

Secondary Outcome Measures

LF/HF ratio
Time to new episode
Mood Rating Scales

Full Information

First Posted
April 28, 2009
Last Updated
April 11, 2013
Sponsor
Ludwig-Maximilians - University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT00891826
Brief Title
Omega-3 Fatty Acids in Bipolar Patients With a Low Omega-3 Index and Reduced Heart Rate Variability
Official Title
Omega-3 Fatty Acids in Bipolar Patients With a Low Omega-3 Index and Reduced Heart Rate Variability: the "BIPO-3" Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ludwig-Maximilians - University of Munich

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorders
Keywords
Bipolar disorders, Omega-3 fatty acids, Heart rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Corn oil
Arm Type
Placebo Comparator
Arm Title
Omega-3 fatty acids
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 fatty acids (EPAX 6015 TG)
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Corn oil
Intervention Description
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.
Primary Outcome Measure Information:
Title
SDNN (msec)
Time Frame
at baseline and after 12 weeks
Secondary Outcome Measure Information:
Title
LF/HF ratio
Time Frame
at baseline and after 12 weeks
Title
Time to new episode
Time Frame
study period (12 weeks)
Title
Mood Rating Scales
Time Frame
at baseline and after 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emanuel Severus, M.D.
Organizational Affiliation
Ludwig-Maximilians - University of Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, University of Munich
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80336
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
35362878
Citation
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.
Results Reference
derived

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

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