Omega 3 Fatty Acid Trial

NCT00586222 | Completed Phase 1

• 1 other identifier: 06-004285
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to detect the metabolic changes that Omega 3 fatty acid treatment has on the brain and to find out whether magnetic resonance spectroscopy (MRS) scan can detect metabolic differences between bipolar patients and healthy control participants.

Conditions

Omega-3 Fatty Acids; Pediatric Bipolar Disorder; Adolescent Bipolar Disorder; Magnetic Resonance Spectroscopy Imaging

Keywords

Omega-3 Fatty Acids; Pediatric Bipolar Disorder; Adolescent Bipolar Disorder; MRS

Outcome Measures

Primary Outcomes (1)

• 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.

  at the 12 week point

Study Arms (3)

2

PLACEBO COMPARATOR

Other: Placebo

Healthy Comparsions

NO INTERVENTION

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.

1

EXPERIMENTAL

Dietary Supplement: Omega-3 Fatty Acid

Interventions

Omega-3 Fatty Acid DIETARY_SUPPLEMENT

600 mg of eicosapentaenoic acid, 340 g of docosahexanoic acid, and 96 mg gama-linoleic acid for 12 weeks.

1

Placebo OTHER

placebo pill of the same size, color, and shape as the dietary supplement.

2

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• cardiac pacemakers
• metallic clips
• other bodily metallic implants
• dental braces
• not fluent in English

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Fatty Acids, Omega-3

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Sencan S Unal, M.D. P

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 4, 2008
• Study Start: January 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: January 25, 2012

Record last verified: 2012-01

Locations

US (1)