TerminatedPhase 4

Omega-3 Fatty Acid Adjunctive to Open-Label Aripiprazole for the Treatment of Bipolar Disorder in Children and Adolescents

Stopped: Supply Omega-3 Fatty Acids expired and supplier no longer made same composition.

United States20 participantsStarted 2007-12

Plain-language summary

This will be a 12 week, double blind study of omega-3 fatty acids vs. placebo adjunctive to open-label aripiprazole treatment in children and adolescents (ages 6-17) who meet DSM-IV criteria for bipolar disorder (BPD) (currently manic or mixed). Specific hypotheses are as follows: Hypothesis 1: Omega-3 fatty acids will be well-tolerated and efficacious in the treatment of children and adolescents with BPD Hypothesis 2: The total dose of aripiprazole will be lower in those subjects receiving active omega-3 treatment

Who can participate

Age range6 Years – 17 Years

SexALL

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Inclusion criteria

✓. Male or female subject, 6-17 years of age
✓. Subject has a DSM-IV diagnosis of bipolar I, bipolar II, or bipolar spectrum disorder and currently displaying manic, hypomanic, or mixed symptoms (with or without psychotic features)
✓. Subject and their legal representative have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol
✓. Subject and their legal representative must be considered reliable
✓. Subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document and the subject must sign an informed assent document
✓. Subject must have an initial score on the Young-Mania Rating Scale (Y-MRS) of at least 20
✓. Subject must be able to participate in mandatory blood draws
✓. Subject must be able to swallow pills

Exclusion criteria

What they're measuring

Change in Bipolar Symptoms as Assessed by Young-Mania Rating Scale (YMRS)

Timeframe: weekly for 1st 6 weeks then biweekly

Trial details

NCT IDNCT00592683

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-04

Results submitted2011-07-15

View on ClinicalTrials.gov More Pediatric Bipolar Disorder trials