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This study consists of a 6-week, open-label, randomized clinical trial study to compare efficacy and tolerability of the natural treatments omega-3 fatty acids, inositol, and N-acetylcysteine (NAC) in the treatment of mood dysregulation in children and adolescents (ages 5-17). Subjects will be randomized to one of two arms: 1) omega-3 fatty acids plus inositol or 2) NAC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega-3 Fatty Acids + Inositol | Experimental | Subjects will be treated with 1020mg QAM + 1020mg QPM of omega-3 fatty acids and inositol based on weight (subjects under 25kg: 1000mg QD; Subjects weighing 25kg or more: 2000mg QD). |
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| N-acetylcysteine | Experimental | Subjects will be treated with N-acetylcysteine capsules (subjects ages 5-12: 1800mg QD; subjects ages 13-17: 2400mg QD) or effervescent tablets (subjects ages 5-12: 1800mg QD; subjects ages 13-17: 2700mg QD) based on age . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open-label Treatment with Omega-3 Fatty Acids + Inositol | Drug | Open-label Treatment with Omega-3 Fatty Acids + Inositol |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in the Parent-Young Mania Rating Scale (P-YMRS) Score | The YMRS consists of 11 items rated on a scale from 0 (symptoms not present) to 4 (symptoms extremely severe). It is used to assess manic symptoms. Scores from each item are summed to obtain the total YMRS score. The YMRS score ranges from 0-60. A higher score means a higher manic state. Questions are asked about the last week. This scale is generally accepted as the main outcome measure in studies of pediatric bipolar disorder and is linked directly to the core symptoms of mania. | Baseline to 6 Weeks (End of Treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in the Parent-completed Children's Depression Inventory (CDI) | The CDI consists of 27 items quantifying symptoms such as depressed mood, hedonic capacity, vegetative functions, self-evaluation, and interpersonal behaviors. Each item consists of three statements graded in order of increasing severity from 0 to 2; parents select the one that characterized their child's symptoms best during the past 1 week. The item scores are combined into a total depression score, which ranges from 0 to 54. A higher CDI score means a higher depressive state. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janet Wozniak, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114-2696 | United States |
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Enrollment numbers represent the number of child and parent/guardian dyads in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Omega-3 Fatty Acids + Inositol | Subjects were treated with 1020mg QAM + 1020mg QPM of omega-3 fatty acids and inositol based on weight (subjects under 25kg: 1000mg QD; Subjects weighing 25kg or more: 2000mg QD). |
| FG001 | N-acetylcysteine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 13, 2023 | Dec 12, 2025 |
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| Open-label Treatment with N-acetylcysteine | Drug | Open-label Treatment with N-acetylcysteine |
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| Baseline to 6 Weeks |
| Mean Change in the NIMH Clinical Global Improvement Scale (CGI) | The CGI is a measure of illness severity adapted for specific disorders. It allows rating of mania, depression and overall bipolar disorder illness, as well as other conditions frequently comorbid with bipolar disorder. The severity score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The improvement score ranges from 1 (very much improved) to 7 (very much worse). | Baseline to 6 Weeks |
Subjects were treated with N-acetylcysteine capsules (subjects ages 5-12: 1800mg QD; subjects ages 13-17: 2400mg QD) or effervescent tablets (subjects ages 5-12: 1800mg QD; subjects ages 13-17: 2700mg QD) based on age . |
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| NOT COMPLETED |
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Baseline Characteristics were collected for child participants and not collected for parent/guardian participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Omega-3 Fatty Acids + Inositol | Subjects will be treated with 1020mg QAM + 1020mg QPM of omega-3 fatty acids and inositol based on weight (subjects under 25kg: 1000mg QD; Subjects weighing 25kg or more: 2000mg QD). Open-label Treatment with Omega-3 Fatty Acids + Inositol: Open-label Treatment with Omega-3 Fatty Acids + Inositol |
| BG001 | N-acetylcysteine | Subjects will be treated with N-acetylcysteine capsules (subjects ages 5-12: 1800mg QD; subjects ages 13-17: 2400mg QD) or effervescent tablets (subjects ages 5-12: 1800mg QD; subjects ages 13-17: 2700mg QD) based on age . Open-label Treatment with N-acetylcysteine: Open-label Treatment with N-acetylcysteine |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Date of Birth | Count of Participants | Participants |
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| Sex: Female, Male | Self Reported Gender | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Self Reported Ethnicity | Count of Participants | Participants |
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| Race (NIH/OMB) | Self Reported Race | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in the Parent-Young Mania Rating Scale (P-YMRS) Score | The YMRS consists of 11 items rated on a scale from 0 (symptoms not present) to 4 (symptoms extremely severe). It is used to assess manic symptoms. Scores from each item are summed to obtain the total YMRS score. The YMRS score ranges from 0-60. A higher score means a higher manic state. Questions are asked about the last week. This scale is generally accepted as the main outcome measure in studies of pediatric bipolar disorder and is linked directly to the core symptoms of mania. | Posted | Mean | Standard Deviation | Units on YMRS Scale | Baseline to 6 Weeks (End of Treatment) |
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| Secondary | Mean Change in the Parent-completed Children's Depression Inventory (CDI) | The CDI consists of 27 items quantifying symptoms such as depressed mood, hedonic capacity, vegetative functions, self-evaluation, and interpersonal behaviors. Each item consists of three statements graded in order of increasing severity from 0 to 2; parents select the one that characterized their child's symptoms best during the past 1 week. The item scores are combined into a total depression score, which ranges from 0 to 54. A higher CDI score means a higher depressive state. | Posted | Mean | Standard Deviation | Units on CDI Scale | Baseline to 6 Weeks |
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| Secondary | Mean Change in the NIMH Clinical Global Improvement Scale (CGI) | The CGI is a measure of illness severity adapted for specific disorders. It allows rating of mania, depression and overall bipolar disorder illness, as well as other conditions frequently comorbid with bipolar disorder. The severity score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The improvement score ranges from 1 (very much improved) to 7 (very much worse). | Posted | Mean | Standard Deviation | Units on CGI-BPS-S Scale | Baseline to 6 Weeks |
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6 weeks (from baseline to end of study)
Adverse Events were collected for children participants taking the treatment, and not collected for parent/guardian participants. Parents/guardians did not take treatment and only completed questionnaires.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omega-3 Fatty Acids + Inositol | Subjects will be treated with 1020mg QAM + 1020mg QPM of omega-3 fatty acids and inositol based on weight (subjects under 25kg: 1000mg QD; Subjects weighing 25kg or more: 2000mg QD). | 0 | 14 | 0 | 14 | 7 | 14 |
| EG001 | N-acetylcysteine | Subjects will be treated with N-acetylcysteine capsules (subjects ages 5-12: 1800mg QD; subjects ages 13-17: 2400mg QD) or effervescent tablets (subjects ages 5-12: 1800mg QD; subjects ages 13-17: 2700mg QD) based on age . | 0 | 13 | 0 | 13 | 2 | 13 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea/Vomit/Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Cold/Infection/Allergy | General disorders | Non-systematic Assessment |
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| Agitated/Irritable | Psychiatric disorders | Non-systematic Assessment |
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| Anxious/Worried | Psychiatric disorders | Non-systematic Assessment |
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| Suicidal Ideation | Psychiatric disorders | Non-systematic Assessment |
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| Tics | Psychiatric disorders | Non-systematic Assessment |
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| Dermatological | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Genitourinary | Renal and urinary disorders | Non-systematic Assessment |
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| Other | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janet Wozniak | Massachusetts General Hospital | 6176436617 | jwozniak@partners.org |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 12, 2025 | Dec 12, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D007294 | Inositol |
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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