- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00586222
Omega 3 Fatty Acid Trial
Neurometabolic Effects of the Essential Polyunsaturated Fatty Acids in Early-Onset Bipolar Disorder: A Magnetic Resonance Spectroscopy Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Bipolar disorder (BP) is a chronic, complex and highly heterogeneous disease that has been unrecognized or misdiagnosed in prepubertal children and adolescents. It is one of the most disabling forms of childhood psychopathology and carries a striking human and economic cost. A high percentage of children and adolescents with BP respond very poorly to existing treatments. There is a significant need for studies identifying the developmentally sensitive targets for novel therapeutic compounds for this truly disabling illness. A growing range of novel therapeutic options for the treatment of BP are under investigation. Highly unsaturated fatty acids of the omega-3 fatty acids are among the novel therapeutic compounds considered in the treatment of adult patients with BP. However, the mood-stabilizing efficacy and the neurometabolic effects of this naturally occurring dietary components have not been examined in pediatric patients with BP.
The objective of this study is to identify magnetic resonance spectroscopic characteristics of adolescents with BP before and during a double-blind, placebo controlled combined omega-3 fatty and omega -6 fatty acid trial. We will compare the spectroscopic findings of the BP group with individually matched healthy comparison subjects before and after the omega-3/omega-6 fatty acid treatment. We will identify a well-described cohort of adolescents (age: 12-18) with BP without catatonic features, psychotic features, or other psychiatric comorbidity. Comorbidity with ADHD will be allowed since this might be a separate phenotype for pediatric BP. We will analyze the differences between BP subjects with comorbid ADHD, and BP subjects without ADHD. We will evaluate subjects with a novel magnetic resonance imaging technique, Magnetic Resonance Spectroscopic Imaging (MRSI). We will use a high-field 3T magnet to perform the MRSI acquisition, and apply a tissue volume correction technique to compare absolute metabolite concentrations rather than metabolite ratios. Previous studies found pronounced abnormalities in the frontal lobes, cingulate cortex, thalamus and basal ganglia of patients with BP. Thus, the region of interest in this study will include these anatomical areas with special emphasis given to prefrontal cortex and anterior cingulate cortex.
To our knowledge, this will be the first study examining omega-3 fatty acid induced changes in the developing brain in vivo. The long-term goal of our research group is to identify the developmentally sensitive, trait and state related magnetic resonance spectroscopic markers of pediatric BP. The preliminary data obtained from this application will be used to design a larger scale, follow-up study to examine whether alterations in brain metabolite measures are clinical state or trait markers and to determine the developmental variability in the patterns of metabolic abnormalities. Such knowledge will provide powerful insight into developmentally sensitive targeted pharmacological interventions. Studying bipolar disorder early in its course will be important to minimize potentially confounding factors, such as the effects of long-term medication use and neurodegeneration related to chronic illness course and substance abuse.
Based on the existing literature, we hypothesized that increased myoinositol levels will be detected in the regions of interests of adolescents with BP in comparison to healthy controls.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 12 to 18 years old
- both male and female
- all ethnic backgrounds
- DSM-IV criteria for Bipolar Disorder without catatonic and psychotic features or other psychiatric comorbidity, except ADHD
Exclusion Criteria:
- cardiac pacemakers
- metallic clips
- other bodily metallic implants
- dental braces
- not fluent in English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
600 mg of eicosapentaenoic acid, 340 g of docosahexanoic acid, and 96 mg gama-linoleic acid for 12 weeks.
|
Placebo Comparator: 2
|
placebo pill of the same size, color, and shape as the dietary supplement.
|
No Intervention: Healthy Comparsions
We will compare the BP group with 32 age-, gender-, and handedness-matched healthy adolescents.
Subjects who have a first or second degree relative with a psychiatric history will be excluded from the healthy comparison group.
Subjects must be safe to undergo MRI scanning as per Mayo MRI safety screening which is explained in detail elsewhere in this protocol.
We will exclude the subjects with cardiac pacemakers, metallic clips, other bodily metallic implants and dental braces because of the MRS procedure.
Subjects who cannot complete clinical assessments or the MRI scan and subjects who are not fluent in English will be excluded from the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cases will classify as either treatment responders or non. Using dichotomous assessment, logistic regression will assess association of regional mI levels and mood measures taken at baseline, adjusting for important covariates such as age and gender.
Time Frame: at the 12 week point
|
at the 12 week point
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sencan S Unal, M.D. P, Mayo Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-004285
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Omega-3 Fatty Acids
-
Josip Juraj Strossmayer University of OsijekUnknownOmega-3 Polyunsaturated Fatty AcidsCroatia
-
USDA Grand Forks Human Nutrition Research CenterUnited States Department of Agriculture (USDA); University of North DakotaCompletedOmega-3 Fatty Acids | Lipid PeroxidationUnited States
-
Medical University of South CarolinaAker Biomarine Antarctic ASCompletedFatty Acids, Omega-3 | Cognition | Nutrition | Resilience, Psychological | Psychology, MilitaryUnited States
-
University of HohenheimCompletedMicronutrients | Human Nutrition, Omega-3 Fatty Acids, MicroalgaeGermany
-
Chang Gung Memorial HospitalNot yet recruiting
-
Indonesia UniversityDanone Institute InternationalCompletedOverweight | Nutritional Status | Complementary Feeding Recommendation | Linear Programming, | Omega-3 Fatty Acids | Malondialdehyde | Alpha-TocopherolIndonesia
-
Bogomolets National Medical UniversityCompletedNAFLD | Type2 Diabetes | Omega-3 Fatty Acids | Probiotic
-
University of GuelphUnknownEffect of Omega-3 Fatty Acid Supplementation Physical FitnessCanada
-
Kuang Tien General HospitalCompletedMigraine | Omega-3 Polyunsaturated Fatty AcidsTaiwan
-
Josip Juraj Strossmayer University of OsijekUnknownVitamin E | Selenium | Lutein | n-3 Polyunsaturated Fatty AcidsCroatia
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States