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

Sponsored by:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00592683

Purpose

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 (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 aripirazole will be lower in those subjects receiving active omega-3 treatment

Condition	Intervention	Phase
Pediatric Bipolar Disorder	Drug: arirpriprazole Dietary Supplement: fish oil	Phase IV

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Aripiprazole Fish oil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment
Official Title:	A Randomized Placebo Controlled Clinical Trial of Omega-3 Fatty Acid Adjunctive to Open-Label Aripiprazole for the Treatment of Bipolar Disorder in Children and Adolescents Ages 6-17 With Bipolar Spectrum Disorder

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

YMRS [ Time Frame: weekly for 1st 6 weeks then biweekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

DSM-IV Mania Symptom Checklist [ Time Frame: weekly for first 6 weeks then biweekly ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	December 2007
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator aripriprazole + fish oil	Drug: arirpriprazole tablet, start at 2mg and increase/decrease each week, taken daily for 12 weeks Dietary Supplement: fish oil 1600mg (4 capsules) daily for 12 weeks
2: Placebo Comparator aripriprazole + placebo	Drug: arirpriprazole tablet, start at 2mg and increase/decrease each week, taken daily for 12 weeks

Detailed Description:

Initial clinical evidence suggests that the omega-3 fatty acids EPA (eicosapentaenoic acid) and/or DHA (docosahexaenoic acid) may play a therapeutic role in the management of mood disorders. EPA is an essential fatty acid, which can be metabolized to DHA and is a component of the human diet if fish is consumed. Aripiprazole is a novel second general antipsychotic that seems to function as a partial agonist at the dopamine D2 and serotonin 5-HT 1A receptors as well as an antagonist at the serotonin 5-HT 2A receptor. Since it has a favorable adverse event profile in adults, it is an attractive choice for the treatment of youth with bipolar disorder if proven efficacious. Although pilot research showed that omega-3 fatty acids monotherapy treatment resulted in improvement of manic symptoms, the improvement is less dramatic than that observed in trials of antipsychotics. We will test the safety and efficacy of omega-3 fatty acids versus placebo as an adjunctive treatment to open-label aripirazole in children and adolescents with bipolar disorder.

The proposed study includes 1) the use of a 12-week design to document the response rate 2) careful assessment of safety and tolerability

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 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 ADHD, ODD, CD, OCD, 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.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592683

Contacts

Contact: Meghan Kotarski, BS

617-503-1051

mkotarski@partners.org

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Cambridge, Massachusetts, United States, 02138

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:

Janet Wozniak, MD

MGH

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	MGH ( Janet Wozniak, MD )
Study ID Numbers:	2007-P-000413
Study First Received:	December 28, 2007
Last Updated:	December 28, 2007
ClinicalTrials.gov Identifier:	NCT00592683
Health Authority:	United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:

bipolar disorder
fish oil
aripriprazole
children

Study placed in the following topic categories:

Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder

Mood Disorders
Psychotic Disorders
Aripiprazole

Additional relevant MeSH terms:

Tranquilizing Agents
Pathologic Processes
Disease
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009