Adults 5 to 12, any sex, with Pediatric Bipolar Spectrum Disorders. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Improvement in Mania Symptoms by Change in Young Mania Rating Scale (YMRS)Primary· Baseline to endpoint (12 weeks or last observation carried forward if dropped prior to week 12)
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.
Group
Value
95% CI
Omega-3/Placebo
-4.8
± 7.9
Placebo/Inositol
-6.4
± 6.4
Omega-3/Inositol
-10.2
± 9.0
Improvement in Depression Symptoms by Children's Depression Rating Scale (CDRS)Primary· Baseline to endpoint (12 weeks or last observation carried forward if dropped prior to week 12)
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.
Group
Value
95% CI
Omega-3/Placebo
-4.9
± 10.6
Placebo/Inositol
-5.6
± 10.1
Omega-3/Inositol
-10.8
± 7.4
Adverse events — posted to ClinicalTrials.gov
Time frame: 12 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Massachusetts General Hospital
Last refreshed: 13 August 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01396486.