Inositol and Omega-3 Fatty Acids in Pediatric Mania

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Janet Wozniak, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01396486
First received: July 15, 2011
Last updated: July 22, 2014
Last verified: July 2014

July 15, 2011
July 22, 2014
February 2012
January 2015   (final data collection date for primary outcome measure)
  • Improvement in mania symptoms by change in Young Mania Rating Scale (YMRS) [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
    Primary outcome measure of efficacy will be assessed by mean change from baseline to endpoint in the Young Mania Rating Scale (YMRS) total score.
  • Improvement in depression symptoms by Children's Depression Rating Scale (CDRS) [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
    Primary outcome measures of efficacy will be assessed by mean change from baseline on the Children's Depression Rating Scale (CDRS).
Same as current
Complete list of historical versions of study NCT01396486 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Inositol and Omega-3 Fatty Acids in Pediatric Mania
A Randomized Controlled Trial of Inositol and Omega-3 Fatty Acids in Pediatric Mania

The purpose of this study is to a) evaluate the efficacy of omega-3 fatty acids versus inositol in the treatment of pediatric bipolar disorder, b) evaluate the efficacy of omega-3 fatty acid plus inositol in the treatment of pediatric bipolar disorder, and c) assess the side effect profile of omega-3 fatty acids plus inositol. This study will be a 12-week trial with children ages 5-12 years old with bipolar spectrum disorders.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pediatric Bipolar Spectrum Disorders
  • Drug: Omega-3
    Children with bipolar spectrum disorders ages 6-12 will receive treatment with omega-3 fatty acids. Study subjects may be randomized to receive 3000mg (6 500mg capsules) of omega-3 fatty acids for the duration of the study. Omega-3 fatty acid capsules are in the form of Nordic Naturals brand, ProOmega Junior, which contains 325mg EPA and 225mg DHA per two capsules.
    Other Name: ProOmega Junior
  • Drug: Inositol
    Children with bipolar spectrum disorders ages 6-12 will receive treatment with inositol, omega-3 fatty acids, or both weekly for 12 weeks. Subjects weighing 25kg or more may be randomized to receive 2000mg (4 500mg capsules) of inositol (80mg/kg for a 25kg child). Children weighing less than 25kg will be dosed at 80mg/kg rounded down to the nearest thousand mg dose. Dosage will remain constant throughout the study.
  • Active Comparator: Omega-3/Placebo
    Combination Omega-3 and Placebo treatment.
    Intervention: Drug: Omega-3
  • Active Comparator: Placebo/Inositol
    Combination Placebo and Inositol treatment.
    Intervention: Drug: Inositol
  • Active Comparator: Omega-3/Inositol
    Combination Omega-3 and Inositol treatment.
    Interventions:
    • Drug: Omega-3
    • Drug: Inositol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
January 2015
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects, 5-12 years of age.
  • Subjects must have a DSM-IV diagnosis of bipolar spectrum disorder (types I, II, and not otherwise specified) and currently be displaying manic, hypomanic, or mixed symptoms (with or without psychotic features) according to the DSM-IV based on clinical assessment and structured diagnostic interview (Kiddie Schedule of Affective Disorders and Schizophrenia Epidemiological Version, Orvaschel, 1994).
  • Subjects and their legal representative must 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.
  • Subjects and their legal representative must be considered reliable.
  • Each 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.
  • Subjects must have an initial total score on the YMRS of at least 20.
  • Subject must be able to participate in mandatory blood draws.
  • Subject must be able to swallow pills.
  • Subjects with ADHD, ODD, conduct disorder, and anxiety will be allowed to participate in the study provided that the impairment associated with these disorders is of a lesser degree of severity relative to the impairment of the bipolar disorder, according to clinician evaluation.

Exclusion Criteria:

  • Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
  • Serious or unstable illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
  • History of bleeding diathesis, including those with von Willebrand disease.
  • Uncorrected hypothyroidism or hyperthyroidism.
  • History of sensitivity to omega-3 fatty acids or inositol. A non-responder or history of intolerance to omega-3 or inositol, after 2 months of treatment at adequate doses as determined by the clinician.
  • Severe allergies or multiple adverse drug reactions.
  • Failed 2 or more previous trials with anti-manic treatments including lithium, anticonvulsants, and atypical antipsychotic medication.
  • Current or past history or seizures.
  • DSM-IV substance use, abuse, or dependence (unlikely in ages 5-12).
  • Judged clinically to be at serious suicidal risk.
  • Any other concomitant medication with primarily central nervous system activity other than no greater than 2mg lorazepam taken no more than 3 days during the study.
  • Current diagnosis of schizophrenia.
  • Pregnancy (unlikely in ages 5-12).
  • Girls who have begun menstruating.
  • YMRS Item #8 (Content) score of 8 ("delusions; hallucinations").
  • YRMS total score above 40.
  • Girls who have begun menstruating.
  • C-SSRS score > 4.
  • IQ <70.
Both
5 Years to 12 Years
No
Contact: Jacqueline Davis, BA 617-643-6617 jodavis@mgh.harvard.edu
Contact: Leah Feinberg, BS 617-726-4651 lkfeinberg@mgh.harvard.edu
United States
 
NCT01396486
2009-P-001937
Yes
Janet Wozniak, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Janet Wozniak, MD Massachusetts General Hospital
Massachusetts General Hospital
July 2014

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