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

NCT00592683 | Terminated Phase 4 Results

• 1 other identifier: 2007-P-000413
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pediatric Bipolar Disorder

Keywords

bipolar disorder; fish oil; aripiprazole; children

Outcome Measures

Primary Outcomes (1)

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

  The YMRS is used to evaluate symptoms of mania in children and adolescents. Items are rated from 0-4 or 0-8, with higher scores indicating greater severity. The minimum total score (least severe) is 0, and the maximum total score (most severe) is 60.

  weekly for 1st 6 weeks then biweekly

Secondary Outcomes (1)

• DSM-IV Mania Symptom Checklist

  weekly for first 6 weeks then biweekly

Study Arms (2)

Aripiprazole plus Fish Oil

ACTIVE COMPARATOR

Subjects administered aripiprazole and randomized to receive fish oil

Drug: Aripiprazole; Dietary Supplement: fish oil

Aripiprazole plus Placebo

PLACEBO COMPARATOR

Subjects administered aripiprazole and randomized to receive placebo

Drug: Aripiprazole; Drug: Placebo

Interventions

Aripiprazole DRUG

tablet, start at 2mg and increase/decrease each week, taken daily for 12 weeks

Also known as: Abilify

Aripiprazole plus Fish Oil; Aripiprazole plus Placebo

fish oil DIETARY_SUPPLEMENT

1600mg (4 capsules) daily for 12 weeks

Aripiprazole plus Fish Oil

Placebo DRUG

Placebo

Aripiprazole plus Placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Cambridge, Massachusetts, 02138, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Aripiprazole; Fish Oils

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Oils; Lipids

Results Point of Contact

• Title: Janet Wozniak, MD
• Organization: Massachusetts General Hospital

jwozniak@partners.org

617-503-1038

Study Officials

• Janet Wozniak, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry at Harvard Medical School and at Massachusetts General Hospital

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: January 14, 2008
• Study Start: December 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: April 6, 2012
• Results First Posted: April 6, 2012

Record last verified: 2012-03

Locations

US (1)