Clinical trial NCT00891826: 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
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorders
Keywords: Bipolar disorders
Omega-3 fatty acids
Heart rate
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2009-05-01
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: SDNN (msec)
timeFrame: at baseline and after 12 weeks
Secondary outcomes:
measure: LF/HF ratio
timeFrame: at baseline and after 12 weeks
measure: Time to new episode
timeFrame: study period (12 weeks)
measure: Mood Rating Scales
timeFrame: at baseline and after 12 weeks
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Psychiatry, University of Munich
state: Bavaria
Study officials:
affiliation: Ludwig-Maximilians - University of Munich
name: Emanuel Severus, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.