Inositol and Omega-3 Fatty Acids in Pediatric Mania

NCT01396486 | Completed Phase 4 Results DMC

• 1 other identifier: 2009-P-001937
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Bipolar Spectrum Disorders

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Improvement in Mania Symptoms by Change in Young Mania Rating Scale (YMRS)

  The Young Mania Rating Scale (YMRS) consists of 7 items rated on a scale from 0 (symptoms not present) to 4 (symptoms extremely severe) and 4 items rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe).The YMRS score ranges from 0-60. Questions are asked about the last week. A higher score signifies more severe manic symptoms.

  Baseline to endpoint (12 weeks or last observation carried forward if dropped prior to week 12)

• Improvement in Depression Symptoms by Children's Depression Rating Scale (CDRS)

  The Children's Depression Rating Scale (CDRS) is a clinician-rated instrument with 17 items scored on a 1 to 5 or 1 to 7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. Scores of 20-30 suggest borderline depression. Scores of 40-60 indicate moderate depression.

  Baseline to endpoint (12 weeks or last observation carried forward if dropped prior to week 12)

Study Arms (3)

Omega-3/Placebo

ACTIVE COMPARATOR

Combination Omega-3 and Placebo treatment.

Drug: Omega-3

Placebo/Inositol

ACTIVE COMPARATOR

Combination Placebo and Inositol treatment.

Drug: Inositol

Omega-3/Inositol

ACTIVE COMPARATOR

Combination Omega-3 and Inositol treatment.

Drug: Omega-3; Drug: Inositol

Interventions

Omega-3 DRUG

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.

Also known as: ProOmega Junior

Omega-3/Inositol; Omega-3/Placebo

Inositol DRUG

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.

Omega-3/Inositol; Placebo/Inositol

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female subjects, 5-12 years of age.
• Subjects must have a DSM-IV diagnosis of a bipolar spectrum disorder (type I, II, or Not Otherwise Specified (NOS)), and currently displaying mixed, manic, or hypomanic symptoms (without psychotic features) according to the DSM-IV based on clinical assessment and confirmed with structured diagnostic interview (Schedule of Affective Disorders and Schizophrenia for School-Age Children - Epidemiological Version (K-SADS-E)) (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 score on the YMRS total score of at least 20.
• Subject must be able to swallow pills.
• Subjects with ADHD and ODD will be allowed to participate in the study provided that the impairment associated with these disorders is of mild or moderate severity (not severe) and milder in severity relative to the impairment of the bipolar disorder, according to clinician evaluation. Subjects with comorbid anxiety disorders will be allowed to participate provided that the impairment associated with the anxiety is of minimal severity, according to clinician evaluation. Subjects with comorbid CD will be excluded.

You may not qualify if:

• 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 fatty acid 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 of seizures.
• DSM-IV substance use, abuse or dependence (unlikely in ages 5-12).
• Judged clinically to be at serious suicidal risk.
• Current diagnosis of schizophrenia.
• Current diagnosis of conduct disorder
• Pregnancy (unlikely in ages 5-12).
• YMRS Item #8 (Content) score of 8 ("delusions; hallucinations").
• YMRS total score above 40.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Wozniak J, Faraone SV, Chan J, Tarko L, Hernandez M, Davis J, Woodworth KY, Biederman J. A randomized clinical trial of high eicosapentaenoic acid omega-3 fatty acids and inositol as monotherapy and in combination in the treatment of pediatric bipolar spectrum disorders: a pilot study. J Clin Psychiatry. 2015 Nov;76(11):1548-55. doi: 10.4088/JCP.14m09267.

  PMID: 26646031 DERIVED

MeSH Terms

Conditions

Mania; Depression

Interventions

Docosahexaenoic Acids; Inositol

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Results Point of Contact

• Title: Dr. Janet Wozniak
• Organization: Massachusetts General Hospital

jwozniak@partners.org

617-724-5600

Study Officials

• Janet Wozniak, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry at Harvard Medical School and at Massachusetts General Hospital

Study Record Dates

• First Submitted: July 15, 2011
• First Posted: July 18, 2011
• Study Start: February 3, 2012
• Primary Completion: April 11, 2019
• Study Completion: April 11, 2019
• Last Updated: August 13, 2020
• Results First Posted: April 21, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)