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Completed

NCT Number: NCT03911414

A Clinical Trial Via Telepsychiatry of Treatments for the Management of Emotional Dysregulation in Youth

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.

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Key information

Conditions

Mood Disturbance Alternative Treatment Mental Disorders Mood Disorders Natural Supplements

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114-2696, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subjects, 5-17 years of age.
  • Current symptoms of emotional dysregulation as indicated by combined T-scores on the Child Behavior Checklist > 180 on the Anxiety/Depression + Aggression + Attention subscales.
  • 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.
  • Subjects and their caregivers must be willing and able to comply with all study procedures.
  • Each subject and his/her parent/guardian must understand the nature of the study. The subject's parent/guardian must sign an informed consent document and the subject must sign an informed assent document.
  • Subject must be able to swallow pills.
  • Subject must have access to a computer with a camera, speaker, microphone, and internet connection.

Exclusion criteria

  • Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
  • Serious or unstable illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
  • History of bleeding diathesis, including those with von Willebrand disease.
  • Uncorrected hypothyroidism or hyperthyroidism.
  • History of sensitivity to omega-3 fatty acids, inositol or NAC. A non-responder or history of intolerance to omega-3 fatty acid, inositol or NAC after 2 months of treatment at adequate doses as determined by the clinician.
  • Severe allergies or multiple adverse drug reactions.
  • Unstable or untreated seizure disorder.
  • DSM-IV substance use, abuse or dependence.
  • Judged clinically to be at serious suicidal risk or C-SSRS score ≥ 4.
  • Current diagnosis of schizophrenia.
  • Current diagnosis or symptoms of psychosis.
  • IQ < 70.
  • Pregnant or nursing.

Treatment and study plan

Open-label Treatment with Omega-3 Fatty Acids + Inositol

Drug

Open-label Treatment with Omega-3 Fatty Acids + Inositol

Open-label Treatment with N-acetylcysteine

Drug

Open-label Treatment with N-acetylcysteine

Primary outcomes

  1. Mean Change in the Parent-Young Mania Rating Scale (P-YMRS) Score

    Time frame: 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.

Secondary outcomes

  1. 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.

  2. 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).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Apr 11, 2019
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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