Management of Emotional Dysregulation in Youth With Non-verbal Learning Disability (NVLD) and/or Autism Spectrum Disorders (ASD) Using Telepsychiatry of Complementary and Alternative Treatments
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|ClinicalTrials.gov Identifier: NCT03757585|
Recruitment Status : Not yet recruiting
First Posted : November 29, 2018
Last Update Posted : December 3, 2018
|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-Acetyl Cysteine||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)|
|Estimated Study Start Date :||December 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Omega-3 Fatty Acids + Inositol
Subjects will be treated with 1500mg QAM + 1500mg QPM of Omega-3 Fatty acids and inositol based on weight (Subjects under 25kg: 80mg per kg, rounded down to the nearest 500mg; Subjects weighing 25kg or more: 1000mg QAM + 1000mg QPM).
Drug: Open-label Treatment with Omega-3 Fatty Acids + Inositol
Open-label Treatment with Omega-3 Fatty Acids + Inositol
Experimental: N-Acetyl Cysteine
Subjects will be treated with N-Acetyl Cysteine based on age (Subjects ages 5-12: 1800mg daily; Subjects ages 13-17: 2700 mg daily).
Drug: Open-label Treatment with N-Acetyl Cysteine
Open-label Treatment with N-Acetyl Cysteine
- 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, BSemail@example.com|
|Contact: Elizabeth Noyes, BAfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Not yet recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Abigail Farrell, BS 617-643-6617 email@example.com|
|Contact: Elizabeth Noyes, BA 617-726-4651 firstname.lastname@example.org|
|Principal Investigator: Janet Wozniak, MD|
|Principal Investigator:||Janet Wozniak, MD||Massachusetts General Hospital|