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

Not Applicable

Completed

• Conditions: Bipolar Disorders
• Interventions: Dietary Supplement: Corn oil; Dietary Supplement: Omega-3 fatty acids (EPAX 6015 TG)

• Registration Number: NCT00891826
• Lead Sponsor: Ludwig-Maximilians - University of Munich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-28
• Study First Submitted QC: 2009-04-30
• Study First Posted: 2009-05-01
• Primary Completion: 2012-06
• Status Verified: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2013-04-11
• Last Update Posted: 2013-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corn oil	Corn oil	-
Omega-3 fatty acids	Omega-3 fatty acids (EPAX 6015 TG)	-

Primary Outcome Measures

Name	Time	Method
SDNN (msec)	at baseline and after 12 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Psychiatry, University of Munich; 🇩🇪 Munich, Bavaria, Germany