Omega-3/Inositol + NAC for Mood Disorders

Overseen By Hannah O'Connor, BS

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Massachusetts General Hospital

Disqualifiers: Serious illness, Seizure disorder, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

37 Participants Needed

Trial Summary

What is the purpose of this trial?

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 (ages 5-17). Subjects will be randomized to one of two arms: 1) omega-3 fatty acids plus inositol or 2) NAC.

Research Team

Janet Wozniak, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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.

Inclusion Criteria

Subjects and their caregivers must be willing and able to comply with all study procedures

Male or female subjects, 5-17 years of age

Subjects and their caregivers must be English-speaking, and have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol

Exclusion Criteria

You have a serious or unstable illness affecting organs like the liver, kidneys, stomach, lungs, heart, or brain.

Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild

You have a history of a bleeding disorder, like von Willebrand disease, that makes it harder for your blood to clot.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either omega-3 fatty acids plus inositol or N-acetylcysteine for mood dysregulation

6 weeks

Conducted via telepsychiatry

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Open-label Treatment with N-acetylcysteine
• Open-label Treatment with Omega-3 Fatty Acids + Inositol

Trial Overview 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.

Participant Groups

Group I: Omega-3 Fatty Acids + Inositol Experimental Treatment 1 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-acetylcysteine Experimental Treatment 1 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 .

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+