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A Randomized Controlled Trial of Inositol and Omega-3 Fatty Acids in Pediatric Mania

ClinicalTrials.gov · COMPLETED, 2019

69 participants

Abstract

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.

Primary outcome: Improvement in Mania Symptoms by Change in Young Mania Rating Scale (YMRS); Improvement in Depression Symptoms by Children's Depression Rating Scale (CDRS).

Enrollment: 69 participants.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 69 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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