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

• Sponsor: Ludwig-Maximilians - University of Munich (Other)
• Overall Status: Completed
• CT.gov ID: NCT00891826
• Collaborator: (none)
• Enrollment: 55
• Location: 1
• Arms: 2
• Duration (Months): 48
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorders	Dietary Supplement: Omega-3 fatty acids (EPAX 6015 TG); Dietary Supplement: Corn oil	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Apr 1, 2009
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Corn oil	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.
Experimental: Omega-3 fatty acids	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.

Outcome Measures

Primary Outcome Measures

1. SDNN (msec) [at baseline and after 12 weeks]

Secondary Outcome Measures

1. LF/HF ratio [at baseline and after 12 weeks]

2. Time to new episode [study period (12 weeks)]

3. Mood Rating Scales [at baseline and after 12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Psychiatry, University of Munich	Munich	Bavaria	Germany	80336

Sponsors and Collaborators

• Ludwig-Maximilians - University of Munich

Investigators

• Principal Investigator: Emanuel Severus, M.D., Ludwig-Maximilians - University of Munich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: W. Emanuel Severus, M.D., University Hospital Dresden
• ClinicalTrials.gov Identifier: NCT00891826
• Other Study ID Numbers: EPAX 103
• First Posted: May 1, 2009
• Last Update Posted: Apr 12, 2013
• Last Verified: Apr 1, 2013

• Keywords provided by W. Emanuel Severus, M.D., University Hospital Dresden: Bipolar disorders; Omega-3 fatty acids; Heart rate
• Additional relevant MeSH terms: Bipolar Disorder

Study Results

No Results Posted as of Apr 12, 2013