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

This study has been terminated.
(Supply Omega-3 Fatty Acids expired and supplier no longer made same composition.)
Sponsor:
Information provided by (Responsible Party):
Janet Wozniak, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00592683
First received: December 28, 2007
Last updated: March 9, 2012
Last verified: March 2012
  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 (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


Condition Intervention Phase
Pediatric Bipolar Disorder
Drug: Aripiprazole
Dietary Supplement: fish oil
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in Bipolar Symptoms as Assessed by Young-Mania Rating Scale (YMRS) [ Time Frame: weekly for 1st 6 weeks then biweekly ] [ Designated as safety issue: No ]
    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.


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


Enrollment: 20
Study Start Date: December 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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: Aripiprazole
tablet, start at 2mg and increase/decrease each week, taken daily for 12 weeks
Other Name: Abilify
Drug: Placebo
Placebo

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

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00592683

Locations
United States, Massachusetts
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Janet Wozniak, MD Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Janet Wozniak, MD, Assistant Professor of Psychiatry at Harvard Medical School and at Massachusetts General Hospital, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00592683     History of Changes
Other Study ID Numbers: 2007-P-000413
Study First Received: December 28, 2007
Results First Received: July 15, 2011
Last Updated: March 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
bipolar disorder
fish oil
aripiprazole
children

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 15, 2014