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

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Pediatric Bipolar Disorder

In brief

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

Key facts

Study ID: NCT00592683
Run by: Massachusetts General Hospital
People needed: 20
Starts: 2007-12-01
Expected to finish: 2010-04-01
Last updated by the study team: 2012-04-06

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
Subjects with comorbid Attention Deficit Hyperactivity Disorder (ADHD), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), Obsessive Compulsive Disorder (OCD), Pervasive Developmental Disorders (PDD), anxiety and depressive disorders will be allowed to participate in the study provided they do not meet for any of exclusionary criteria
For concomitant therapy used to treat ADHD, subject must have been on a stable dose of the medication for 1 month prior to study enrollment. The dose of the ADHD therapy may not change throughout the duration of the study.

You may not qualify if…

Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild
Serious, unstable illness including heptic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease
Uncorrected hypothyroidism or hyperthyroidism
History of sensitivity to omega-3 fatty acids. A non-responder or history of intolerance to omega-3 fatty acid, after treatment at adequate doses as determined by the clinician.
Severe allergies or multiple adverse drug reactions.
Non-febrile seizures without a clear and resolved etiology
DSM-IV substance (except nicotine or caffeine) dependence within past 6 months
Judged clinically to be at serious suicidal risk
Any other concomitant medication with primarily central nervous system activity other than specified in the Concomitant Medication portion of the protocol.
Current diagnosis of schizophrenia
Pregnant or nursing females

Where it is running

Massachusetts General Hospital — Cambridge, Massachusetts, United States

Full record on ClinicalTrials.gov

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