A Phase 4 interventional study of Omega-3 and Inositol in Pediatric Bipolar Spectrum Disorders, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2020-08-13.
Sponsored by Massachusetts General Hospital · Phase 4, Interventional, and Treatment
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.
The investigators propose to conduct a randomized, double blind, controlled trial that will evaluate effectiveness and tolerability of omega-3 fatty acids and inositol used alone and in combination. The investigators plan to decrease the variability in the population under study by limiting the age range to 5-12 years and excluding cases with significant, untreated, comorbidity. The cognitive effects/side effects with a neuropsychological battery pre and post treatment will be measured. Subjects with a history of failing treatment with two or more conventional treatments will be excluded.
This will be a 12-week, double-blind, randomized clinical trial study to compare efficacy and tolerability of the natural treatments omega-3 fatty acids and inositol used in combination in the treatment of bipolar spectrum disorders in children and adolescents (ages 5-12). Subjects will be randomized in double blind fashion to one of three arms: omega-3 fatty acids, inositol or the combined treatment. Further, the proposed study will include measures of cognition prior to starting study medication and at endpoint. The investigators will minimize the variability of the population under study by limiting the age range to 5-12 years, minimizing untreated or clinically significant comorbidity and excluding subjects who have already failed treatment with 2 or more anti-manic agents. Subjects will include youth ages 5-12 years with a bipolar spectrum disorder (type I, II, or NOS), mixed, manic, or hypomanic state, according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (American Psychiatric Association, 2000) (DSM-IV), randomized to 3 treatment arms: 1) treatment with omega-3 fatty acids (N=20); 2) treatment with inositol (N=20); 3) treatment with the combination of inositol and omega-3 fatty acids (N=20).
166 studies on the registry are indexed under Mania; 13 are open to participants now.
This study's enrollment of 69 is below the median of 89 across 138 interventional studies indexed under Mania.
Browse Mania studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Combination Omega-3 and Placebo treatment.
Drug: Omega-3
Combination Placebo and Inositol treatment.
Drug: Inositol
Combination Omega-3 and Inositol treatment.
Drug: Omega-3 · Drug: Inositol
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
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.
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.
Time frame: 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.
Time frame: Baseline to endpoint (12 weeks or last observation carried forward if dropped prior to week 12)
| Milestone | Omega-3/Placebo | Placebo/Inositol | Omega-3/Inositol |
|---|---|---|---|
| Started | 20 | 19 | 22 |
| Exposed | 19 | 16 | 17 |
| Completed | 10 | 7 | 10 |
| Not completed | 10 | 12 | 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.
| units on a scale | Omega-3/Placebo | Placebo/Inositol | Omega-3/Inositol |
|---|---|---|---|
| Improvement in Mania Symptoms by Change in Young Mania Rating Scale (YMRS) | -4.8 ± 7.9 | -6.4 ± 6.4 | -10.2 ± 9.0 |
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.
| units on a scale | Omega-3/Placebo | Placebo/Inositol | Omega-3/Inositol |
|---|---|---|---|
| Improvement in Depression Symptoms by Children's Depression Rating Scale (CDRS) | -4.9 ± 10.6 | -5.6 ± 10.1 | -10.8 ± 7.4 |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Omega-3/Placebo | 0/20 (0%) | 1/20 (5%) | 13/20 (65%) |
| Placebo/Inositol | 0/19 (0%) | 1/19 (5.3%) | 12/19 (63.2%) |
| Omega-3/Inositol | 0/22 (0%) | 0/22 (0%) | 10/22 (45.5%) |
| Event | Omega-3/Placebo | Placebo/Inositol | Omega-3/Inositol |
|---|---|---|---|
| Agitated/IrritablePsychiatric disorders | 1/20 | 1/19 | 0/22 |
| Event | Omega-3/Placebo | Placebo/Inositol | Omega-3/Inositol |
|---|---|---|---|
| Nausea/Vomit/DiarrheaGastrointestinal disorders | 4/20 | 1/19 | 3/22 |
| Cold/Infection/AllergyInfections and infestations | 3/20 | 1/19 | 1/22 |
| Agitated/IrritablePsychiatric disorders | 1/20 | 2/19 | 0/22 |
| Increased AppetiteGeneral disorders | 0/20 | 2/19 | 1/22 |
| HeadacheGeneral disorders | 0/20 | 1/19 | 1/22 |
| InsomniaNervous system disorders | 0/20 | 1/19 | 1/22 |
| SedationNervous system disorders | 0/20 | 1/19 | 0/22 |
| Weight GainGeneral disorders | 0/20 | 1/19 | 0/22 |
| Psychotic EpisodePsychiatric disorders | 0/20 | 1/19 | 0/22 |
| Sleep WalkingNervous system disorders | 0/20 | 1/19 | 0/22 |
| Age, Continuous(years) | Omega-3/Placebo | Placebo/Inositol | Omega-3/Inositol | Total |
|---|---|---|---|---|
| Mean | 7.8 ± 1.6 | 8.8 ± 2.3 | 8.4 ± 2.5 | 8.3 ± 2.2 |
| Sex: Female, Male(Participants) | Omega-3/Placebo | Placebo/Inositol | Omega-3/Inositol | Total |
|---|---|---|---|---|
| Female | 8 | 4 | 8 | 20 |
| Male | 11 | 12 | 9 | 32 |
| Ethnicity (NIH/OMB)(Participants) | Omega-3/Placebo | Placebo/Inositol | Omega-3/Inositol | Total |
|---|---|---|---|---|
| Hispanic or Latino | 4 | 2 | 0 | 6 |
| Not Hispanic or Latino | 14 | 14 | 17 | 45 |
| Unknown or Not Reported | 1 | 0 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Omega-3/Placebo | Placebo/Inositol | Omega-3/Inositol | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 | 2 |
| White | 16 | 14 | 16 | 46 |
| More than one race | 1 | 1 | 0 | 2 |
| Unknown or Not Reported | 2 | 0 | 0 | 2 |
| Region of Enrollment(participants) | Omega-3/Placebo | Placebo/Inositol | Omega-3/Inositol | Total |
|---|---|---|---|---|
| United States | 19 | 16 | 17 | 52 |
| YMRS(units on a scale) | Omega-3/Placebo | Placebo/Inositol | Omega-3/Inositol | Total |
|---|---|---|---|---|
| Mean | 26.1 ± 7.2 | 25.8 ± 6.5 | 24.2 ± 5.8 | 25.4 ± 6.5 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drugs tested here: Omega-3 fatty acid · Inositol
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