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

NCT00891826 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2013-04-12

No results posted yet for this study

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.

Conditions

  • Bipolar Disorders

Interventions

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.

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.

Sponsors & Collaborators

  • Ludwig-Maximilians - University of Munich

    lead OTHER

Principal Investigators

  • Emanuel Severus, M.D. · Ludwig-Maximilians - University of Munich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2012-06-30
Completion
2013-04-30

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00891826 on ClinicalTrials.gov