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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests natural treatments for children and teens who struggle with managing emotions, which may manifest as anxiety, aggression, or attention issues. It compares two treatments: one group will take omega-3 fatty acids combined with inositol, while the other will take N-acetylcysteine (NAC, a supplement). Children and teens who often feel overwhelmed by their emotions and can swallow pills might be suitable for this study. The trial aims to determine which treatment is more effective and how well they are tolerated. As a Phase 4 trial, the treatments have already received FDA approval and have proven effective, providing an opportunity to assess their benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What is the safety track record for these treatments?

A previous study found N-acetylcysteine (NAC) to be safe for managing neurological disorders, indicating it is generally well-tolerated with few side effects. Another review showed that NAC reduced symptoms in mood disorders like bipolar disorder without causing major problems.

Research has indicated that omega-3 fatty acids and inositol are also safe. One study found these natural products helped with mood disorders in children and teens and were gentle on the body, causing no significant side effects.

Both treatments have been studied for various conditions, and results suggest they are safe options with minimal risk of side effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because they offer a novel approach to managing mood disorders. Unlike conventional treatments like antidepressants or mood stabilizers, N-acetylcysteine (NAC) and Omega-3 Fatty Acids with Inositol work differently. NAC is known for its antioxidant properties, which help reduce oxidative stress in the brain, while Omega-3s and Inositol support brain health by influencing neurotransmitter function. These treatments have the potential to improve mood disorders with fewer side effects, offering a promising alternative to existing medications.

What evidence suggests that this trial's treatments could be effective for mood disorders?

Research has shown that N-acetylcysteine (NAC), which participants in this trial may receive, can help reduce symptoms of mood disorders. Studies indicate it improves mood in conditions like bipolar disorder, with patients experiencing noticeable reductions in depression. Similarly, clinical trials have demonstrated that omega-3 fatty acids combined with inositol, another treatment option in this trial, improve both manic and depressive symptoms. These supplements were well-tolerated and provided symptom relief for people with bipolar disorder. Overall, both treatments show promise in easing mood disorders, with strong evidence supporting their effectiveness. ^{4 6 7 8 9}

Who Is on the Research Team?

Janet Wozniak, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33354859/

N-acetylcysteine as an adjunctive treatment for bipolar ... Results from six clinical trials suggest that treatment augmentation with NAC for bipolar depression appears to be superior to placebo.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0163834324002238

Efficacy of N-acetylcysteine for patients with depression Conclusion. Our findings indicate that adjunctive NAC can ameliorate depressive symptoms in patients with psychiatric problems, particularly bipolar disorder.

3. psychopharmacologyinstitute.com psychopharmacologyinstitute.com/section/exploring-the-evidence-of-n-acetyl-cysteine-nac-for-mood-disorders-2768-5582/

Exploring the Evidence of N-Acetyl-Cysteine (NAC) for ... 53% of the patients completed the study and it was found that they had a significant reduction in various mood scales such as the Young Mania ...

4. psychiatrist.com psychiatrist.com/jcp/efficacy-adjunctive-n-acetylcysteine-major-depressive/

The Efficacy of Adjunctive N-Acetylcysteine in Major ... Clinically, N-acetylcysteine has demonstrated efficacy in the treatment of schizophrenia, mood symptoms in bipolar disorder, smoking and cannabis cessation, ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21719110/

The efficacy of N-acetylcysteine as an adjunctive treatment ... Conclusion: These open label data demonstrate a robust decrement in depression scores with NAC treatment. Large placebo controlled trials of acute bipolar ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3044191/

N-acetylcysteine in psychiatry: current therapeutic ... This review outlines the current literature regarding the use of NAC in disorders including addiction, compulsive and grooming disorders, schizophrenia and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9095537/

The Potential of N-Acetyl-L-Cysteine (NAC) in the Treatment of ... Secondary analysis of this paper found that NAC significantly reduced suicidal ideation as measured on the MADRS and BDRS; however, it had no significant effect ...

8. hhs.texas.gov hhs.texas.gov/sites/default/files/documents/acetylcysteine-nac-monograph.pdf

N-acetylcysteine (NAC) monograph NAC has the most evidence for its use in the treatment of negative symptoms of schizophrenia (if treatment continues for at least 24 weeks), ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0028390825002333

The neuroprotective effects of N-acetylcysteine in ... NAC remains among the strongest candidates with a high safety profile for managing several types of neurological disorders.