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

NCT ID: NCT00592683

Last Updated: 2012-04-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2010-04-30

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

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

Conditions

Pediatric Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Aripiprazole plus Fish Oil

Subjects administered aripiprazole and randomized to receive fish oil

Group Type: ACTIVE_COMPARATOR

Aripiprazole

Intervention Type: DRUG

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

fish oil

Intervention Type: DIETARY_SUPPLEMENT

1600mg (4 capsules) daily for 12 weeks

Aripiprazole plus Placebo

Subjects administered aripiprazole and randomized to receive placebo

Group Type: PLACEBO_COMPARATOR

Aripiprazole

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Placebo

Interventions

Aripiprazole

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

Intervention Type: DRUG

fish oil

1600mg (4 capsules) daily for 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

Abilify

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Janet Wozniak, MD

Assistant Professor of Psychiatry at Harvard Medical School and at Massachusetts General Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Janet Wozniak, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Cambridge, Massachusetts, United States

Countries

United States

Related Links

http://massgeneral.org/pediatricpsych/home.html

Related Info

Other Identifiers

2007-P-000413

Identifier Type: -

Identifier Source: org_study_id