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

Bipolar Disorders Clinical Trial

Official title:

Omega-3 Fatty Acids in Bipolar Patients With a Low Omega-3 Index and Reduced Heart Rate Variability: the "BIPO-3" Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00891826
• Other study ID #: EPAX 103
• Status: Completed
• Phase: N/A
• First received: April 28, 2009
• Last updated: April 11, 2013
• Start date: April 2009
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: April 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Department of Psychiatry, University of Munich	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SDNN (msec)		at baseline and after 12 weeks	No
Secondary	LF/HF ratio		at baseline and after 12 weeks	No
Secondary	Time to new episode		study period (12 weeks)	No
Secondary	Mood Rating Scales		at baseline and after 12 weeks	No