Trial Outcomes & Findings for A Clinical Trial Via Telepsychiatry of Treatments for the Management of Emotional Dysregulation in Youth (NCT NCT03911414)
NCT ID: NCT03911414
Last Updated: 2026-03-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
27 participants
Primary outcome timeframe
Baseline to 6 Weeks (End of Treatment)
Results posted on
2026-03-18
Participant Flow
Enrollment numbers represent the number of child and parent/guardian dyads in the study.
Participant milestones
| Measure |
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).
|
N-acetylcysteine
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 .
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Trial Via Telepsychiatry of Treatments for the Management of Emotional Dysregulation in Youth
Baseline characteristics by cohort
| Measure |
Omega-3 Fatty Acids + Inositol
n=14 Participants
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
|
N-acetylcysteine
n=13 Participants
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
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
14 Participants
n=110 Participants
|
13 Participants
n=114 Participants
|
27 Participants
n=224 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=110 Participants
|
5 Participants
n=114 Participants
|
8 Participants
n=224 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=110 Participants
|
8 Participants
n=114 Participants
|
19 Participants
n=224 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=224 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=110 Participants
|
13 Participants
n=114 Participants
|
25 Participants
n=224 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=224 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=110 Participants
|
2 Participants
n=114 Participants
|
2 Participants
n=224 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=110 Participants
|
9 Participants
n=114 Participants
|
20 Participants
n=224 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=110 Participants
|
2 Participants
n=114 Participants
|
4 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=224 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 Weeks (End of Treatment)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.
Outcome measures
| Measure |
N-acetylcysteine
n=10 Participants
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 .
|
Omega-3 Fatty Acids + Inositol
n=9 Participants
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).
|
|---|---|---|
|
Mean Change in the Parent-Young Mania Rating Scale (P-YMRS) Score
|
-1.9 Units on YMRS Scale
Standard Deviation 5.9
|
-2.4 Units on YMRS Scale
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: Baseline to 6 WeeksThe 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.
Outcome measures
| Measure |
N-acetylcysteine
n=10 Participants
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 .
|
Omega-3 Fatty Acids + Inositol
n=9 Participants
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).
|
|---|---|---|
|
Mean Change in the Parent-completed Children's Depression Inventory (CDI)
|
-3.5 Units on CDI Scale
Standard Deviation 8.5
|
-1.7 Units on CDI Scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Baseline to 6 WeeksThe 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).
Outcome measures
| Measure |
N-acetylcysteine
n=10 Participants
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 .
|
Omega-3 Fatty Acids + Inositol
n=9 Participants
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).
|
|---|---|---|
|
Mean Change in the NIMH Clinical Global Improvement Scale (CGI)
|
-0.6 Units on CGI-BPS-S Scale
Standard Deviation 0.7
|
-0.6 Units on CGI-BPS-S Scale
Standard Deviation 0.9
|
Adverse Events
Omega-3 Fatty Acids + Inositol
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
N-acetylcysteine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Omega-3 Fatty Acids + Inositol
n=14 participants at risk
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).
|
N-acetylcysteine
n=13 participants at risk
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 .
|
|---|---|---|
|
General disorders
Cold/Infection/Allergy
|
7.1%
1/14 • Number of events 3 • 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.
|
0.00%
0/13 • 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.
|
|
Psychiatric disorders
Agitated/Irritable
|
7.1%
1/14 • Number of events 1 • 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.
|
0.00%
0/13 • 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.
|
|
Psychiatric disorders
Anxious/Worried
|
7.1%
1/14 • Number of events 1 • 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.
|
7.7%
1/13 • Number of events 1 • 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.
|
|
Psychiatric disorders
Suicidal Ideation
|
7.1%
1/14 • Number of events 1 • 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.
|
0.00%
0/13 • 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.
|
|
Psychiatric disorders
Tics
|
7.1%
1/14 • Number of events 1 • 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.
|
0.00%
0/13 • 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.
|
|
Skin and subcutaneous tissue disorders
Dermatological
|
7.1%
1/14 • Number of events 1 • 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.
|
0.00%
0/13 • 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.
|
|
Renal and urinary disorders
Genitourinary
|
0.00%
0/14 • 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.
|
7.7%
1/13 • Number of events 1 • 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.
|
|
General disorders
Other
|
7.1%
1/14 • Number of events 1 • 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.
|
0.00%
0/13 • 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.
|
|
Gastrointestinal disorders
Nausea/Vomit/Diarrhea
|
35.7%
5/14 • Number of events 8 • 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.
|
0.00%
0/13 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place