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

Primary Purpose

Mood Disturbance, Mood Disorders, Natural Supplements

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Open-label Treatment with Omega-3 Fatty Acids + Inositol
Open-label Treatment with N-acetylcysteine
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mood Disturbance

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Omega-3 Fatty Acids + Inositol

N-acetylcysteine

Arm Description

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).

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 .

Outcomes

Primary Outcome Measures

Mean Change in the Parent-Young Mania Rating Scale (P-YMRS) Score
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 Outcome Measures

Mean Change in the Parent-completed Children's Depression Inventory (CDI)
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.
Mean Change in the NIMH Clinical Global Improvement scale (CGI)
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).

Full Information

First Posted
April 9, 2019
Last Updated
July 13, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03911414
Brief Title
A Clinical Trial Via Telepsychiatry of Treatments for the Management of Emotional Dysregulation in Youth
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 18, 2019 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mood Disturbance, Mood Disorders, Natural Supplements, Alternative Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Omega-3 Fatty Acids + Inositol
Arm Type
Experimental
Arm Description
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).
Arm Title
N-acetylcysteine
Arm Type
Experimental
Arm Description
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 .
Intervention Type
Drug
Intervention Name(s)
Open-label Treatment with Omega-3 Fatty Acids + Inositol
Intervention Description
Open-label Treatment with Omega-3 Fatty Acids + Inositol
Intervention Type
Drug
Intervention Name(s)
Open-label Treatment with N-acetylcysteine
Intervention Description
Open-label Treatment with N-acetylcysteine
Primary Outcome Measure Information:
Title
Mean Change in the Parent-Young Mania Rating Scale (P-YMRS) Score
Description
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.
Time Frame
Baseline to 6 Weeks
Secondary Outcome Measure Information:
Title
Mean Change in the Parent-completed Children's Depression Inventory (CDI)
Description
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.
Time Frame
Baseline to 6 Weeks
Title
Mean Change in the NIMH Clinical Global Improvement scale (CGI)
Description
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).
Time Frame
Baseline to 6 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah O'Connor, BS
Phone
617-643-6617
Email
hgoconnor@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet Wozniak, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114-2696
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannah O'Connor, BS
Phone
617-643-6617
Email
hgoconnor@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Janet Wozniak, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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