CompletedPhase 4

Inositol and Omega-3 Fatty Acids in Pediatric Mania

United States69 participantsStarted 2012-02-03

Plain-language 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.

Who can participate

Age range5 Years – 12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

What they're measuring

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

Timeframe: 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)

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

Trial details

NCT IDNCT01396486

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-04-11

Results submitted2020-04-06

View on ClinicalTrials.gov More Pediatric Bipolar Spectrum Disorders trials

Plain-language summary

Who can participate

Age range5 Years – 12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

What they're measuring

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

Timeframe: 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)

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