Alternative Treatment, Mood Disorders, Mood Disturbance, Natural Supplements
Conditions
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.
Interventions
Open-label Treatment with Omega-3 Fatty Acids + Inositol
Open-label Treatment with N-acetylcysteine
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in the Parent-Young Mania Rating Scale (P-YMRS) Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in the Parent-completed Children's Depression Inventory (CDI) | 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. |
| Mean Change in the NIMH Clinical Global Improvement Scale (CGI) | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJanet Wozniak, MD
Massachusetts General Hospital
Participant flow
Pre-assignment details
Enrollment numbers represent the number of child and parent/guardian dyads in the study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 27 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 13 |
| other Total, other adverse events | 7 / 14 | 2 / 13 |
| serious Total, serious adverse events | 0 / 14 | 0 / 13 |
Outcome results
None listed