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Omega-3/Inositol + NAC for Mood Disorders

Phase 4
Recruiting
Led By Janet Wozniak, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 weeks
Awards & highlights

Study Summary

This trial will compare the effectiveness of omega-3 fatty acids, inositol, and N-acetylcysteine (NAC) in treating mood dysregulation in children and adolescents.

Who is the study for?
This trial is for English-speaking children and adolescents aged 5-17 with emotional dysregulation who can swallow pills, use a computer with internet for telepsychiatry sessions, and have caregiver support. Excluded are those with serious illnesses, low IQ (<70), substance abuse issues, severe allergies or adverse drug reactions, thyroid disorders, pregnancy/nursing status, or high suicide risk.Check my eligibility
What is being tested?
The study compares the effectiveness of two natural treatments: Omega-3 fatty acids plus inositol versus N-acetylcysteine (NAC) over six weeks to manage mood swings in youth. Participants will be randomly assigned to one of these open-label treatment groups via telepsychiatry.See study design
What are the potential side effects?
Potential side effects may include digestive discomfort from omega-3s or NAC and possible allergic reactions if sensitive to any components. Since it's an open-label study using natural supplements known for their safety profile, fewer side effects are expected compared to pharmaceutical drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Change in the Parent-Young Mania Rating Scale (P-YMRS) Score
Secondary outcome measures
Mean Change in the NIMH Clinical Global Improvement scale (CGI)
Mean Change in the Parent-completed Children's Depression Inventory (CDI)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Omega-3 Fatty Acids + InositolExperimental Treatment1 Intervention
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).
Group II: N-acetylcysteineExperimental Treatment1 Intervention
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 .

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,431 Total Patients Enrolled
Janet Wozniak, MDPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital
Joan And Stanford I. Weill Medical College Of Cornell Uni (Medical School)
Mass Gen Hospital (Residency)
9 Previous Clinical Trials
365 Total Patients Enrolled

Media Library

Open-label Treatment with N-acetylcysteine (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03911414 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are persons aged 20 or more being admitted to this investigation?

"This study seeks to enroll children aged 5-17 years old. There are 30 trials specifically for minors and 89 studies catered towards those above the retirement age of 65."

Answered by AI

Has any additional research been conducted on Open-label Treatment with N-acetylcysteine?

"Currently, there are 58 clinical studies assessing Open-label Treatment with N-acetylcysteine. Of these, 12 trials are in their final phase of development. Whilst the majority of research is based within Boston, Massachusetts; a total of 81 different medical centres across the US have launched investigations for this potential therapy."

Answered by AI

What conditions respond favorably to open-label treatment with N-acetylcysteine?

"Open-label Treatment with N-acetylcysteine is an efficient method of treating corneal ulceration, acute rhinitis, and acetaminophen."

Answered by AI

May I be included in this exploration?

"To qualify for this research initiative, participants must suffer from a mood disorder and be between 5-17 years old. Ultimately, 60 individuals will be accepted into the trial."

Answered by AI

What is the aggregate size of the cohort participating in this experiment?

"Affirmative. According to the information available on clinicaltrials.gov, enrollment is ongoing for this medical trial which was initially posted on June 18th 2019 and has been updated as recently as November 1st 2022. Sixty patients are needed across one site in order to complete the study."

Answered by AI

To what extent may Open-label Treatment with N-acetylcysteine be hazardous to individuals?

"N-acetylcysteine has been successfully passed through Phase 4 trials and therefore is approved for use, thus receiving a score of 3 in our safety assessment."

Answered by AI

Is the research team still recruiting individuals for this trial?

"Affirmative. The clinicaltrials.gov website displays that this medical trial is presently recruiting participants; it was initially posted on June 18th 2019 and has been updated as recent as November 1st 2022. This study seeks to find 60 subjects across a single site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Clinical Trial Via Telepsychiatry of Treatments for the Management of Emotional Dysregulation in Youth
Janet Wozniak, MD 2019. "A Clinical Trial Via Telepsychiatry of Treatments for the Management of Emotional Dysregulation in Youth". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03911414.
~7 spots leftby Jan 2025
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