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| ID | Type | Description | Link |
|---|---|---|---|
| 5R21AT002927 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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Published studies on omega 3 fatty acids in the treatment of bipolar disorder and schizophrenia have shown reductions in time to recurrence, a decrease in the positive and negative symptoms of schizophrenia, and improvements in Clinical Global Impression Scale, Young Mania Rating Scale, and HAM-D scores. The following are the hypotheses:
This study is an innovative treatment approach to autism. It adapts a promising adjunct therapy for bipolar disorder and schizophrenia to a new population, that of children and adolescents with autism. It will analyze the possible relationship between dosage of omega 3 fatty acids and treatment outcomes. Finally, it will attempt to identify which specific subgroups of subjects will respond to this intervention, which components and associated features are most responsive and whether this impacts subjects' quality of life. The data generated by this study is intended to support the rationale for a full scale, large multi-site clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega 3 fatty Acids, drug | Active Comparator | Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study. |
|
| Placebo | Placebo Comparator | The placebo will be dispensed to subjects in the control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega 3 fatty acids | Drug | The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression Scale(CGI)- Improvement | This scale measures the impression of improvement as assessed from interviewing the subject and informant.The scale is measured with numbers from 0 through 7 with 0 not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. Units = scores on a scale. | Administered biweekly, endpoint score (week 12) only used for data analysis |
| Aberrant Behavior Checklist (ABC) | Aberrant Behavior Checklist (ABC)-Community Version (Irritability Subscale) (Aman et al. 1985). It is designed to objectively identify five behavior subscales through observation by the primary caregiver. The five behavior subscales include (ranges show no problem to severe problem): irritability (range 0-45), lethargy (range 0-48), stereotypy (range 0-21), hyperactivity range 0-48), and inappropriate speech (range 0-12), all possible signs and symptoms of affective instability in autistic individuals (Lainhart & Folstein, 1994). Improvement is shown with scores decreasing over time. Total score is not used. Inter-rater reliability for the ABC-CV is moderate to high across subscales with a mean of .63. Test-retest reliability correlations are .98 -Irritability, .99 -Lethargy, .98 -Stereotypy, .98 -Hyperactivity, and .96 -Inappropriate Speech. The ABC will be filled out by an informant (teacher/parent), and then reviewed by the IE. Administration time is approximately 10 minutes. | Administered every 4 weeks, 12 week scores used for means, score on irritability subscale reported |
| Vineland Adaptive Behavior Scale | The Vineland Scale is a semi-structured informant interview that assesses subjects' functioning. It is administered to a caretaker/family member. The scale has been revised and standardized in all populations. This scale has been found to assess social deficits in autism and strengths in daily living skills. Items are classified under four major adaptive domains: communication, daily living skills, socialization and motor skills. The items are scored 0-2 (yes/sometimes/never). Each domain is summed, and the domain scores are converted to standardized scores. The normative score is 100, with standard deviation of 15. The standardized score is used in this study. A higher score (above 100) means better adaptive behavior. Minimum value is 0, maximum value is infinity. |
| Measure | Description | Time Frame |
|---|---|---|
| Overt Aggression Scale-Modified | The Modified version, Coccaro et al. is designed for outpatient use and assessment of behavior over one week. This scale was assessed biweekly. The OAS-M consists of 3 domains: Aggression, Irritability, and Suicidality (not used). Aggression Domain: 4 subscales of weighted behavior: Verbal Aggression (1), Aggression Against Objects (2), Aggression Against Others (3), and Self-Aggression (4). Within each category, severity of an event receives a scaled score (0-5) (higher score for worse behaviors) which is then multiplied by the weekly frequency of this event and weight, then totaled (for use in this study). Irritability subscale is divided into subjective/objective, 0 (low)-5 (high). The total scale has a minimum value of 0 (no display of aggressive/irritable behavior) and a maximum value of infinity (worse aggressive/irritable behavior) as reporting the number of times an aggressive/irritable behavior occurred does not have a maximum value). Higher scores mean worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sherie L. Novotny, MD | Division of Child and Adolescent Psychiatry at the University of Medicine and Dentistry of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Behavioral Health Care Building, UMDNJ-RWJMS | Piscataway | New Jersey | 08854 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Amminger GP, Berger GE, Schafer MR, Klier C, Friedrich MH, Feucht M. Omega-3 Fatty Acids Supplementation in Children with Autism. Biol Psychiatry. 2006 Aug 22 Harel Z, Gascon G, Riggs S, Vaz R, Brown W, Exil G. Supplementation with omega-3 polyunsaturated fatty acids in the management of recurrent migraines in adolescents. J Adolesc Health. 2002 Aug;31(2):154-61. Itomura M, Hamazaki K, Sawazaki S, Kobayashi M, Terasawa K, Watanabe S, Hamazaki T. The effect of fish oil on physical aggression in schoolchildren. J Nutr Biochem. 2005 Mar;16(3):163-71. Mitchell EA, Aman MG, Turbott SH, Manku M. Clinical characteristics and serum essential fatty acid levels in hyperactive children. Clin Pediatr 1987; 26:406-11. Nemets H, Nemets B, Apter A, Bracha Z, Belmaker RH Omega-3 treatment of childhood depression: Am J Psychiatry. 2006 Jun;163(6):1098-100. Richardson AJ, Montgomery P. The Oxford-Durham study. Pediatrics. 2005 May;115(5):1360-6. |
| Label | URL |
|---|---|
| University Behavior Health Care official website | View source |
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There is no plan at this time.
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Participants were required to undergo diagnostic testing and intelligence testing prior to starting the study. Individuals who were unable to participate in these processes were not allowed to enter into the active phase of the study.
Recruitment was difficult for this study due to multiple disruptions in the flow of the study due to issues with the IRB process. Additionally, there were periods of time when there was not a research coordinator to assist with recruitment and pt flow.
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| ID | Title | Description |
|---|---|---|
| FG000 | Omega 3 Fatty Acids, Drug | Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study. Omega 3 fatty acids : The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly. |
| FG001 | Placebo | The placebo will be dispensed to subjects in the control group Placebo : Same dosage as that of omega 3 fatty acids |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Omega 3 Fatty Acids, Drug | Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study. Omega 3 fatty acids : The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Global Impression Scale(CGI)- Improvement | This scale measures the impression of improvement as assessed from interviewing the subject and informant.The scale is measured with numbers from 0 through 7 with 0 not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. Units = scores on a scale. | Posted | Mean | Standard Deviation | units on a scale | Administered biweekly, endpoint score (week 12) only used for data analysis |
|
The adverse event data were collected over the course of the study from the start in 2007 until completion in 2011. Each participant was observed for adverse events during the course of their treatment which was the course of the study, ie 12 weeks. Participants were not monitored for adverse events after the completion of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omega 3 Fatty Acids, Drug | Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study. Omega 3 fatty acids : The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Recurrence of mood disorder in one participant | Psychiatric disorders | Non-systematic Assessment | One subject had a recurrence of a psychiatric issue ( although might be unrelated to the intake of the placebo which he was on) which lead to hospitalization and discontinuation of taking the placebo and subsequent withdrawal from the study. |
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One subject had a recurrence of a psychiatric issue ( although might be unrelated to the intake of the placebo which he was on) which lead to hospitalisation and discontinuation of taking the placebo and subsequent withdrawal from the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sherie Novotny MD | UMDNJ | (732) 235-4119 | novotnsl@rutgers.edu |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D000374 | Aggression |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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|
| Placebo | Other | Same dosage as that of omega 3 fatty acids |
|
| Administered during the baseline visit and on week 12 ( termination) |
| Administered biweekly and at week 12 (termination) |
| Parental Stress Index | This measurement assesses child and parental characteristics and parent-child relationship dimensions associated with the presence of parenting stress/ troubled relationships. It is a self-report scale completed by the parent, consisting of 101 items organized into two domains with the following subscales: (1) child characteristics domain - adaptability, demandingness, mood, distractibility/hyperactivity, acceptability of child to parent, and child's reinforcement of parent, and (2) parent characteristics domain - depression, attachment to child, social isolation, sense of competence in the parenting role, relationship with spouse/parenting partner, role restrictions, and parental health. Scores are 1-5 with 1 being strongly agree and 5 being strongly disagree. Scores are collected and standardized. The higher a score is, the more stress a parent is experiencing. Minimum value is 101 and maximum value is 505. | Administered during the baseline visit and on week 12 ( termination) |
The placebo will be dispensed to subjects in the control group Placebo : Same dosage as that of omega 3 fatty acids |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Placebo |
The placebo will be dispensed to subjects in the control group Placebo : Same dosage as that of omega 3 fatty acids |
|
|
|
| Primary | Aberrant Behavior Checklist (ABC) | Aberrant Behavior Checklist (ABC)-Community Version (Irritability Subscale) (Aman et al. 1985). It is designed to objectively identify five behavior subscales through observation by the primary caregiver. The five behavior subscales include (ranges show no problem to severe problem): irritability (range 0-45), lethargy (range 0-48), stereotypy (range 0-21), hyperactivity range 0-48), and inappropriate speech (range 0-12), all possible signs and symptoms of affective instability in autistic individuals (Lainhart & Folstein, 1994). Improvement is shown with scores decreasing over time. Total score is not used. Inter-rater reliability for the ABC-CV is moderate to high across subscales with a mean of .63. Test-retest reliability correlations are .98 -Irritability, .99 -Lethargy, .98 -Stereotypy, .98 -Hyperactivity, and .96 -Inappropriate Speech. The ABC will be filled out by an informant (teacher/parent), and then reviewed by the IE. Administration time is approximately 10 minutes. | Youth and adolescents ages 5-17 with autism spectrum disorder | Posted | Mean | Standard Deviation | units on a scale | Administered every 4 weeks, 12 week scores used for means, score on irritability subscale reported |
|
|
|
|
| Primary | Vineland Adaptive Behavior Scale | The Vineland Scale is a semi-structured informant interview that assesses subjects' functioning. It is administered to a caretaker/family member. The scale has been revised and standardized in all populations. This scale has been found to assess social deficits in autism and strengths in daily living skills. Items are classified under four major adaptive domains: communication, daily living skills, socialization and motor skills. The items are scored 0-2 (yes/sometimes/never). Each domain is summed, and the domain scores are converted to standardized scores. The normative score is 100, with standard deviation of 15. The standardized score is used in this study. A higher score (above 100) means better adaptive behavior. Minimum value is 0, maximum value is infinity. | Posted | Mean | Standard Deviation | units on a scale | Administered during the baseline visit and on week 12 ( termination) |
|
|
|
| Secondary | Overt Aggression Scale-Modified | The Modified version, Coccaro et al. is designed for outpatient use and assessment of behavior over one week. This scale was assessed biweekly. The OAS-M consists of 3 domains: Aggression, Irritability, and Suicidality (not used). Aggression Domain: 4 subscales of weighted behavior: Verbal Aggression (1), Aggression Against Objects (2), Aggression Against Others (3), and Self-Aggression (4). Within each category, severity of an event receives a scaled score (0-5) (higher score for worse behaviors) which is then multiplied by the weekly frequency of this event and weight, then totaled (for use in this study). Irritability subscale is divided into subjective/objective, 0 (low)-5 (high). The total scale has a minimum value of 0 (no display of aggressive/irritable behavior) and a maximum value of infinity (worse aggressive/irritable behavior) as reporting the number of times an aggressive/irritable behavior occurred does not have a maximum value). Higher scores mean worse outcome. | Posted | Mean | Standard Deviation | units on a scale | Administered biweekly and at week 12 (termination) |
|
|
|
|
| Secondary | Parental Stress Index | This measurement assesses child and parental characteristics and parent-child relationship dimensions associated with the presence of parenting stress/ troubled relationships. It is a self-report scale completed by the parent, consisting of 101 items organized into two domains with the following subscales: (1) child characteristics domain - adaptability, demandingness, mood, distractibility/hyperactivity, acceptability of child to parent, and child's reinforcement of parent, and (2) parent characteristics domain - depression, attachment to child, social isolation, sense of competence in the parenting role, relationship with spouse/parenting partner, role restrictions, and parental health. Scores are 1-5 with 1 being strongly agree and 5 being strongly disagree. Scores are collected and standardized. The higher a score is, the more stress a parent is experiencing. Minimum value is 101 and maximum value is 505. | Posted | Mean | Standard Deviation | units on a scale | Administered during the baseline visit and on week 12 ( termination) |
|
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Placebo | The placebo will be dispensed to subjects in the control group Placebo : Same dosage as that of omega 3 fatty acids | 1 | 8 | 0 | 8 |
|
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| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012919 | Social Behavior |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |