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

March 9, 2012 updated by: Janet Wozniak, MD, Massachusetts General Hospital

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 aripiprazole 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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female subject, 6-17 years of age
  2. 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)
  3. 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
  4. Subject and their legal representative must be considered reliable
  5. 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
  6. Subject must have an initial score on the Young-Mania Rating Scale (Y-MRS) of at least 20
  7. Subject must be able to participate in mandatory blood draws
  8. Subject must be able to swallow pills
  9. 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
  10. 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:

  1. Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild
  2. Serious, unstable illness including heptic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease
  3. Uncorrected hypothyroidism or hyperthyroidism
  4. 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.
  5. Severe allergies or multiple adverse drug reactions.
  6. Non-febrile seizures without a clear and resolved etiology
  7. DSM-IV substance (except nicotine or caffeine) dependence within past 6 months
  8. Judged clinically to be at serious suicidal risk
  9. Any other concomitant medication with primarily central nervous system activity other than specified in the Concomitant Medication portion of the protocol.
  10. Current diagnosis of schizophrenia
  11. Pregnant or nursing females

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Aripiprazole plus Fish Oil
Subjects administered aripiprazole and randomized to receive fish oil
Drug: Aripiprazole
tablet, start at 2mg and increase/decrease each week, taken daily for 12 weeks
Other Names:
  • Abilify
Dietary supplement: fish oil
1600mg (4 capsules) daily for 12 weeks
Placebo Comparator: Aripiprazole plus Placebo
Subjects administered aripiprazole and randomized to receive placebo
Drug: Placebo
Placebo
Drug: Aripiprazole
tablet, start at 2mg and increase/decrease each week, taken daily for 12 weeks
Other Names:
  • Abilify

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Bipolar Symptoms as Assessed by Young-Mania Rating Scale (YMRS)
Time Frame: weekly for 1st 6 weeks then biweekly
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
DSM-IV Mania Symptom Checklist
Time Frame: weekly for first 6 weeks then biweekly
The DSM-IV Mania Symptom Checklist is used to evaluate symptoms of mania. Item scores range from 0-3, with larger scores indicating greater severity. With 33 items, the maximum (most severe) score possible is 99, with the minimum (least severe) score possible being 0.
weekly for first 6 weeks then biweekly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

December 28, 2007

First Submitted That Met QC Criteria

December 28, 2007

First Posted (Estimate)

January 14, 2008

Study Record Updates

Last Update Posted (Estimate)

April 6, 2012

Last Update Submitted That Met QC Criteria

March 9, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-P-000413

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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