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| Name | Class |
|---|---|
| Demarest Lloyd Jr. Foundation | UNKNOWN |
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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 with non-verbal learning disability (NVLD) or Autism Spectrum Disorder (ASD). Subjects will include youth ages 5-17 years with a non-verbal learning disability (NVLD) or autism spectrum disorder (ASD) and current symptoms of emotional dysregulation.
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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: 2400 mg QD) or effervescent tablets (subjects ages 5-12: 1800mg QD; subjects ages 13-17: 2700 mg 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. The YMRS score ranges from 0-60. 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. Higher scores indicate more severe manic symptoms. | Baseline to 6 Weeks |
| 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 | United States |
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Participants may also be recruited from the referral pool of existing and new patients in the Pediatric Psychopharmacology Program and the MGH Child Psychiatry Outpatient Clinic or from the pool of children screened for participation in Protocol #2019-P-000846 ("An Open-Label Clinical Trial Conducted via Telepsychiatry of Complementary and Alternative Treatments (Omega-3 Fatty Acids and Inositol vs. N-acetylcysteine) for the Management of Emotional Dysregulation in Youth").
We will use advertisements on the Internet, including advertisements posted on the Partners Clinical trials website, and flyers to recruit participants. Individuals who respond to advertising will go through a phone screen with the study coordinator or research assistant via phone and will then be screened by a study clinician.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| 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 22, 2023 | Apr 23, 2025 |
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| Open-label Treatment with N-acetylcysteine | Drug | Open-label Treatment with acetylcysteine |
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| Baseline to 6 Weeks |
| Mean Change in the NIMH Clinical Global Improvement Scale (CGI) | The CGI-BPD-S is a clinician-rated measure of bipolar disorder severity. Severity scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The outcome reported reflects the change from baseline in CGI-BPD-S scores and negative scores represent improvement (i.e., decrease in severity from baseline). | Baseline to 6 Weeks |
Subjects will be treated with N-acetylcysteine capsules (subjects ages 5-12: 1800mg QD; subjects ages 13-17: 2400 mg QD) or effervescent tablets (subjects ages 5-12: 1800mg QD; subjects ages 13-17: 2700 mg QD) based on age. |
| COMPLETED |
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| NOT COMPLETED |
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Equal numbers of baseline participants in each group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Omega-3 Fatty Acid Plus Inositol | Subjects randomized to receive omega-3 fatty acids plus inositol received 2040mg (6 340mg capsules) of omega-3 fatty acids for the duration of the study. Subjects weighing 25kg or more also received 2000mg (2 1000mg capsules) of inositol per day. Children weighing less than 25kg received 1000mg (1 1000mg capsule) of inositol per day |
| BG001 | N-Acetylcysteine | Subjects randomized to receive NAC received NAC in either an effervescent tablet (PharmaNAC brand was chosen due to its palatability and ease of administration) or could instead opt for NAC encapsulated. For those who chose to take NAC in the effervescent tablet form, subjects age 12 and under received 1800mg daily (2 900 mg tablets) NAC and subjects age 13-17 received NAC 2700mg (3 900mg tablets) daily. For those who chose to take NAC in the capsule form, subjects age 12 and under received 1800mg (3 600mg capsules) of NAC daily and subjects age 13-17 received 2400mg (4 600mg capsules) of NAC daily. |
| 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 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | 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. The YMRS score ranges from 0-60. 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. Higher scores indicate more severe manic symptoms. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to 6 Weeks |
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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 a Scale | Baseline to 6 Weeks |
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| Secondary | Mean Change in the NIMH Clinical Global Improvement Scale (CGI) | The CGI-BPD-S is a clinician-rated measure of bipolar disorder severity. Severity scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The outcome reported reflects the change from baseline in CGI-BPD-S scores and negative scores represent improvement (i.e., decrease in severity from baseline). | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to 6 Weeks |
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Adverse events were monitored from enrollment until end of study, on average 6 weeks.
Poor response to treatment, leading to drop from the study, was measured by a CGI-bipolar score that is 2 points higher (more severe) than baseline for more than 2 consecutive weeks or a P-YMRS score that is 30% higher than baseline for more than 2 consecutive weeks only if the P-YMRS is in a clinically significant range of >15. If a subject scores=d a 4 or higher on the C-SSRS, they were dropped from the study.
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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 Acid Plus Inositol | Subjects randomized to receive omega-3 fatty acids plus inositol received 2040mg (6 340mg capsules) of omega-3 fatty acids for the duration of the study. Subjects weighing 25kg or more also received 2000mg (2 1000mg capsules) of inositol per day. Children weighing less than 25kg received 1000mg (1 1000mg capsule) of inositol per day | 0 | 27 | 0 | 27 | 11 | 27 |
| EG001 | N-Acetylcysteine | Subjects randomized to receive NAC received NAC in either an effervescent tablet (PharmaNAC brand was chosen due to its palatability and ease of administration) or could instead opt for NAC encapsulated. For those who chose to take NAC in the effervescent tablet form, subjects age 12 and under received 1800mg daily (2 900 mg tablets) NAC and subjects age 13-17 received NAC 2700mg (3 900mg tablets) daily. For those who chose to take NAC in the capsule form, subjects age 12 and under received 1800mg (3 600mg capsules) of NAC daily and subjects age 13-17 received 2400mg (4 600mg capsules) of NAC daily. | 0 | 27 | 1 | 27 | 13 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | Non-systematic Assessment |
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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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| Headache | General disorders | Non-systematic Assessment |
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| Increased Energy | General disorders | Systematic Assessment |
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| Tics | Psychiatric disorders | Systematic Assessment |
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| Agitated/ Irritable | Psychiatric disorders | Systematic Assessment |
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| Anxious/ Worried | Psychiatric disorders | Systematic Assessment |
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| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Decreased Energy | General disorders | Systematic Assessment |
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| Cold/Infection/Allergy | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Dermatological | Skin and subcutaneous tissue 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_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 23, 2025 | May 27, 2025 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| D007859 | Learning Disabilities |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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| 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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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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