Inositol and Omega-3 Fatty Acids in Pediatric Mania

• Status: Completed
• Trial end date: 2019-04-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Inositol

Criteria

Inclusion Criteria:

1. Male or female subjects, 5-12 years of age.

2. 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).

3. 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.

4. Subjects and their legal representative must be considered reliable.

5. 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.

6. Subjects must have an initial score on the YMRS total score of at least 20.

7. Subject must be able to swallow pills.

8. 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:

1. Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.

2. Serious or unstable illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.

3. History of bleeding diathesis, including those with von Willebrand disease.

4. Uncorrected hypothyroidism or hyperthyroidism.

5. 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.

6. Severe allergies or multiple adverse drug reactions.

7. Failed 2 or more previous trials with anti-manic treatments including lithium, anticonvulsants and atypical antipsychotic medication.

8. Current or past history of seizures.

9. DSM-IV substance use, abuse or dependence (unlikely in ages 5-12).

10. Judged clinically to be at serious suicidal risk.

11. Current diagnosis of schizophrenia.

12. Current diagnosis of conduct disorder

13. Pregnancy (unlikely in ages 5-12).

14. YMRS Item #8 (Content) score of 8 ("delusions; hallucinations").

15. YMRS total score above 40.

16. Girls who have begun menstruating.

17. C-SSRS score ≥ 4.

18. IQ < 70.