NCT00252486

Brief Summary

The purpose of this study is to test the hypothesis that flax oil, as an omega-3 fatty acid, will be superior to placebo in the maintenance treatment of bipolar disorder in children and adolescents. Our primary objective was to determine if flax oil is efficacious in the pediatric bipolar population for reducing symptoms of mania and depression. A secondary objective was to examine fatty acid levels as predictors of treatment response and symptom severity. This clinical trial evaluated whether supplementation with flax oil, containing the omega-3 fatty acid alpha-linolenic acid (alpha-LNA), safely reduced symptom severity in youth with bipolar disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2005

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

3.6 years

First QC Date

November 9, 2005

Last Update Submit

June 17, 2013

Conditions

Bipolar Disorder

Keywords

BipolarOmega-3 Fatty acids

Outcome Measures

Primary Outcomes (3)

  • Young Mania Rating Scale (YMRS)

    EOW 2,4,6,8,10,12,16

  • Children's Depression Rating Scale (CDRS-R)

    EOW 2,4,6,8,10,12,16

  • Clinical Global Impression - Bipolar Version (CGI)

    EOW 2,4,6,8,10,12,16

Study Arms (1)

Flax oil, placebo oil

PLACEBO COMPARATOR
Drug: Flax oil

Interventions

Flax oilDRUG

Flax oil and olive oil placebo were analyzed for quality and purity; sufficient bioactivity was confirmed for the flax oil independently at the University of Massachusetts mid-way through the study. Each capsule of omega -3 fatty acid concentrate contained 550 mg of α-linolenic acid (α-LNA) from flax seed oil.A stepped but flexible dose-titration schedule was carried out with doses increased by 1-2 grams at each visit as tolerated, to an attempted total dose of 6 capsules twice per day, as requested by the FDA (up to 6.6 grams of daily α-linolenic acid).

Also known as: Omega-3 Research Institute, Bethesda, MD
Flax oil, placebo oil

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • male and female outpatients aged 6-17
  • DSM-IV diagnosis of bipolar I or II disorder
  • currently symptomatic with a CGI of 3 or greater, Y-MRS of 4 or greater, or CDRS-R of 22 or greater
  • have failed stabilization with lithium and valproate combined therapy with therapeutic levels documented or are intolerant to these medications
  • ability and willingness to provide assent and informed written consent from at least one parent/ legal guardian

You may not qualify if:

  • mental retardation (IQ less than 70)
  • comorbid autism, pervasive developmental disorder, history of substance abuse or positive toxicology screen, or acute post-traumatic stress disorder
  • presence of a serious chronic medical illness
  • inability to swallow capsules
  • pregnant or sexually active without reliable contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (3)

  • Scheffer RE, Kowatch RA, Carmody T, Rush AJ. Randomized, placebo-controlled trial of mixed amphetamine salts for symptoms of comorbid ADHD in pediatric bipolar disorder after mood stabilization with divalproex sodium. Am J Psychiatry. 2005 Jan;162(1):58-64. doi: 10.1176/appi.ajp.162.1.58.

    PMID: 15625202BACKGROUND

  • McClellan J, Kowatch R, Findling RL; Work Group on Quality Issues. Practice parameter for the assessment and treatment of children and adolescents with bipolar disorder. J Am Acad Child Adolesc Psychiatry. 2007 Jan;46(1):107-125. doi: 10.1097/01.chi.0000242240.69678.c4.

    PMID: 17195735BACKGROUND

  • Nandagopal JJ, DelBello MP, Kowatch R. Pharmacologic treatment of pediatric bipolar disorder. Child Adolesc Psychiatr Clin N Am. 2009 Apr;18(2):455-69, x. doi: 10.1016/j.chc.2008.11.004.

    PMID: 19264273BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Linseed Oil

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Fats, UnsaturatedFatsLipidsPlant OilsOilsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Barbara L Gracious, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2005

First Posted

November 11, 2005

Study Start

November 1, 2001

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

US(1)