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Trial record 85 of 405 for:    ARIPIPRAZOLE

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

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ClinicalTrials.gov Identifier: NCT00592683
Recruitment Status : Terminated (Supply Omega-3 Fatty Acids expired and supplier no longer made same composition.)
First Posted : January 14, 2008
Results First Posted : April 6, 2012
Last Update Posted : April 6, 2012
Sponsor:
Information provided by (Responsible Party):
Janet Wozniak, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE December 28, 2007
First Posted Date  ICMJE January 14, 2008
Results First Submitted Date  ICMJE July 15, 2011
Results First Posted Date  ICMJE April 6, 2012
Last Update Posted Date April 6, 2012
Study Start Date  ICMJE December 2007
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 28, 2007)
YMRS [ Time Frame: weekly for 1st 6 weeks then biweekly ]
Change History Complete list of historical versions of study NCT00592683 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2012)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 28, 2007)
DSM-IV Mania Symptom Checklist [ Time Frame: weekly for first 6 weeks then biweekly ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Omega-3 Fatty Acid Adjunctive to Open-Label Aripiprazole for the Treatment of Bipolar Disorder in Children and Adolescents
Official Title  ICMJE 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
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pediatric Bipolar Disorder
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Active Comparator: Aripiprazole plus Fish Oil
    Subjects administered aripiprazole and randomized to receive fish oil
    Interventions:
    • Drug: Aripiprazole
    • Dietary Supplement: fish oil
  • Placebo Comparator: Aripiprazole plus Placebo
    Subjects administered aripiprazole and randomized to receive placebo
    Interventions:
    • Drug: Aripiprazole
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 25, 2011)
20
Original Estimated Enrollment  ICMJE
 (submitted: December 28, 2007)
40
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00592683
Other Study ID Numbers  ICMJE 2007-P-000413
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janet Wozniak, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Janet Wozniak, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP