Inositol and Omega-3 Fatty Acids in Pediatric Mania

This study is currently recruiting participants. (see Contacts and Locations)

Verified February 2015 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: February 2, 2015

Last verified: February 2015

History of Changes

Purpose

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.

Condition	Intervention	Phase
Pediatric Bipolar Spectrum Disorders	Drug: Omega-3 Drug: Inositol	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized Controlled Trial of Inositol and Omega-3 Fatty Acids in Pediatric Mania

Resource links provided by NLM:

Drug Information available for: Inositol Omega-3 Fatty Acids

Genetic and Rare Diseases Information Center resources: Children's Interstitial Lung Disease

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

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).


Estimated Enrollment:	60
Study Start Date:	February 2012
Estimated Study Completion Date:	January 2017
Estimated Primary Completion Date:	January 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Omega-3/Placebo Combination Omega-3 and Placebo treatment.	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
Active Comparator: Placebo/Inositol Combination Placebo and Inositol treatment.	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/Inositol Combination Omega-3 and Inositol treatment.	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.

Eligibility


Ages Eligible for Study:	5 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396486

Contacts


Contact: Jacqueline Davis, BA	617-643-6617	jodavis@mgh.harvard.edu
Contact: Leah Feinberg, BS	617-726-4651	lkfeinberg@mgh.harvard.edu

Locations


United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators


Principal Investigator:	Janet Wozniak, MD	Massachusetts General Hospital

More 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:	NCT01396486 History of Changes
Other Study ID Numbers:	2009-P-001937
Study First Received:	July 15, 2011
Last Updated:	February 2, 2015
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:


Omega-3 Fatty Acids Fish Oil Inositol Natural supplements	Bipolar Spectrum Disorders Mania Depression Children

Additional relevant MeSH terms:


Inositol Growth Substances Micronutrients Pharmacologic Actions	Physiological Effects of Drugs Vitamin B Complex Vitamins

ClinicalTrials.gov processed this record on March 01, 2015

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