Natural Treatments for the Management of Emotional Dysregulation in Youth With Non-verbal Learning Disability (NVLD) and/or Autism Spectrum Disorders (ASD)
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|ClinicalTrials.gov Identifier: NCT03757585|
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : June 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non-verbal Learning Disorder Autism Spectrum Disorder Autism||Drug: Open-label Treatment with Omega-3 Fatty Acids + Inositol Drug: Open-label Treatment with N-acetylcysteine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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 With Non-verbal Learning Disability (NVLD) and/or Autism Spectrum Disorders (ASD)|
|Actual Study Start Date :||May 20, 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: 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).
Drug: Open-label Treatment with Omega-3 Fatty Acids + Inositol
Open-label Treatment with Omega-3 Fatty Acids + Inositol
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.
Drug: Open-label Treatment with N-acetylcysteine
Open-label Treatment with acetylcysteine
- Mean Change in the Parent-Young Mania Rating Scale (P-YMRS) Score [ Time Frame: Baseline to 6 Weeks ]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.
- Mean Change in the Parent-completed Children's Depression Inventory (CDI) [ Time Frame: Baseline to 6 Weeks ]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.
- Mean Change in the NIMH Clinical Global Improvement scale (CGI) [ Time Frame: Baseline to 6 Weeks ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03757585
|Contact: Abigail Farrell, BSfirstname.lastname@example.org|
|Contact: Haley Driscoll, BAemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Abigail Farrell, BS 617-643-6617 firstname.lastname@example.org|
|Contact: Haley Driscoll, BA 617-724-2551 email@example.com|
|Principal Investigator: Janet Wozniak, MD|
|Principal Investigator:||Janet Wozniak, MD||Massachusetts General Hospital|