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This is a 6-week open trial to identify the optimal dosing of cannabidiol (CBD) in youth with autism spectrum disorder (ASD) and to identify primary and secondary outcomes for future controlled studies. This study evaluates change in symptoms commonly associated with ASD, as evidence suggests that CBD may be effective in addressing difficulties such as irritability and anxiety, while maintaining a benign adverse effect (AE) profile in children and adolescents.
30 male and female participants with ASD between the ages of 7 and 17 years old are being recruited. Participants have fluent speech and an estimated IQ greater than or equal to 80. Study intervention is 98% pure CBD. The CBD is Greenwich Biosciences, Inc.'s 100mg/mL oral solution, brand name EPIDIOLEX. First, a Bayesian optimal interval (BOIN) design was used, such that participants were assigned to cohorts of size 3 receiving doses of 3, 6, or 9 mg/kg/day, depending on the treatment response of participants in prior cohorts.
The BOIN design ended after the fifth cohort of participants, and the two lower doses, 3 and 6 mg/kg/day, were eliminated. The highest dose, 9 mg/kg/day, was not tested. Therefore, in subsequent cohorts, we will be examining 9 mg/kg/day exclusively in up to 15 additional participants with co-occurring ASD and attention-deficit/hyperactivity disorder (ADHD) diagnoses, as this clinical profile appears to most closely resemble youth classified as responders within the BOIN design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 98% pure CBD | Experimental | 98% pure CBD. The CBD will be 100mg/mL oral solution provided by Greenwich Biosciences, Inc. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 98% pure CBD | Drug | A Bayesian optimal interval (BOIN) design was used, such that participants were assigned to cohorts of size 3 receiving doses of 3, 6, or 9 mg/kg/day, depending on the treatment response of participants in prior cohorts. The BOIN design has ended, and two doses have been tested and eliminated (3 and 6 mg/kg/day). We are now examining 9 mg/kg/day exclusively. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression Scale-Improvement (CGI-I) | The physician-rated CGI-I comprises one question asking how much a participant's condition has changed since baseline. The item is answered using a 7-point Likert scale, where 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; and 7 = very much worse. The total score is the item response; lower scores indicate greater improvement. | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Repetitive Behavior Scale-Revised (RBS-R) Score | The RBS-R is a 43-item self report used to measure the breadth of repetitive behavior in children. For each item, behaviors are rated on a 4-point scale: 0-Behavior does not occur, 1-Behavior occurs and is a mild problem, 2-Behavior occurs and is a moderate problem, 3-Behavior occurs and is a severe problem. On the last question, participants are asked to "lump together" all of the behaviors described in the questionnaire, and provide a rating for how much of a problem these repetitive behaviors are overall, on a scale from 1-100: 1-Not a problem at all, to 100-As bad as you can imagine. A decrease in scores indicates the repetitive behaviors became less of a problem overall. The total score is the sum of all items and ranges from 0 to 229. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco X Castellanos, MD | New York Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42204954 | Derived | Lawson J, Robinson L, Conlon GR, Shalev RA, Cervantes PE, Yoncheva Y, Hirsch GS, Troxel AB, Friedman D, Devinsky O, Castellanos FX. A Phase-2 Open-Label Trial of Cannabidiol to Treat Core and Associated Symptoms of Autism in Children and Adolescents Without Intellectual Disability. J Child Adolesc Psychopharmacol. 2026 Aug;36(6):350-358. doi: 10.1177/10445463261452514. Epub 2026 May 28. |
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Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in the investigator's University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting requests and accessing data may be found at (Link to be provided).
Data will be available for any purpose.
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| ID | Title | Description |
|---|---|---|
| FG000 | 3 mg/kg 98% Pure CBD | Participants who received 98% pure CBD: 3 mg/kg/day in Part 1 of the study. |
| FG001 | 6 mg/kg 98% Pure CBD | Participants who received 98% pure CBD: 6 mg/kg/day in Part 1 of the study. |
| FG002 | 9 mg/kg 98% Pure CBD | Participants who received 98% pure CBD: 9 mg/kg/day in Part 2 of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 3 mg/kg 98% Pure CBD | Participants who received 98% pure CBD: 3 mg/kg/day in Part 1 of the study. |
| BG001 | 6 mg/kg 98% Pure CBD | Participants who received 98% pure CBD: 6 mg/kg/day in Part 1 of the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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-Improvement (CGI-I) | The physician-rated CGI-I comprises one question asking how much a participant's condition has changed since baseline. The item is answered using a 7-point Likert scale, where 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; and 7 = very much worse. The total score is the item response; lower scores indicate greater improvement. | Posted | Mean | Standard Deviation | score on a scale | Week 6 |
|
6 weeks after participant received first dose.
PI monitor for adverse events (AEs) at each follow-up visit. Study coordinator phone call to parents/caregivers to assess for AEs at weeks 1, 3, and 5. Participants and caregivers completed UKU Side Effects Rating Scale at weeks 2, 4, and 6. Participants were not assessed for all-cause mortality.
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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 | 3 mg/kg 98% Pure CBD | Participants who received 98% pure CBD: 3 mg/kg/day in Part 1 of the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations/Tachycardia | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Francisco X Castellanos, MD | NYU Langone Health | 646-754-5194 | Francisco.Castellanos@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 13, 2022 | Apr 9, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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|
| Baseline, Week 6 |
| Change in Social Responsiveness Scale, 2nd Edition (SRS-2), School-Age Form Score | The SRS-2 is a 65-item questionnaire assessing Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests and Repetitive Behavior. Items are scored on a 4-point scale (ranging from 1=not true to 4=almost always true). The raw score is the sum of responses and is converted to a T-score; the final T-score has a mean of 50 points with a standard deviation of 10 points, where lower scores indicate greater social responsiveness:
| Baseline, Week 6 |
| Change in Aberrant Behavior Checklist (ABC) - Irritability Subscale Score | The ABC Irritability subscale comprises 15 items rated on a 4-point scale (ranging from 0=no problem at all to 3 = problem is severe in degree). The total score is the sum of responses and ranges from 0 to 45; higher scores indicate greater presences of irritability related behavior. | Baseline, Week 6 |
| Change in Screen for Child Anxiety Related Disorders (SCARED), Parent Version Score | The SCARED, Parent Version is a 41-item parent-report measure developed to measure child anxiety symptoms. Subscales include Somatic Symptoms/Panic Disorder, Generalized Anxiety Disorder, Separation Anxiety, Social Phobia, and School Phobia. Items are rated on a 3-point scale ranging from 0=not true or hardly ever true to 2=very true or often true. The total score is the sum of responses and ranges from 0 to 82; lower scores indicate lesser child anxiety symptoms. | Baseline, Week 6 |
| Change in Sleep Disturbance Scale for Children (SDSC) Score | The SDSC is a 26-item parent-completed assessment of their child's sleep-wake rhythm. The questionnaire measures Disorders of Initiating and Maintaining Sleep, Sleep Breathing Disorders, Disorders of Arousal, Sleep Wake Transition Disorders, Disorders of Excessive Somnolence, and Sleep Hyperhydrosis. Items are rated on 5-point scale where 1=never and 5=always (daily). The total score is the sum of responses and ranges from 26 to 130; lower scores indicate healthier sleep-wake rhythms. | Baseline, Week 6 |
| Change in Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) Parent/Caregiver Form Score | Used to measure adaptive functioning across three core domains (Communication, Daily Living Skills, and Socialization), and two optional domains (Motor Skills and Maladaptive Behavior); items are rated on a 3-point scale (0=never; 1=sometimes; 2=usually or often). The core domains sum to a total Adaptive Behavior Composite. The range of possible composite scores ranges from 20-140, with a higher score indicating higher levels of adaptive functioning. | Baseline, Week 6 |
| Change in Clinical Global Impression-Severity (CGI-S) Score | 1-item assessment of clinicians impression of severity of illness. Illness severity is rated on a 7-point scale ranging from 1=not at all to 7=among the most extremely ill. | Baseline, Week 6 |
| Change in Autism Family Experience Questionnaire (AFEQ) Score | Parent/Caregiver form used to measure impact of autism interventions on family experience and quality of life. Items are rated on a 5-point scale where 1=always and 5=never. The total score is the sum of responses and ranges from 48 - 240; lower scores indicate better outcomes. | Baseline, Week 6 |
| Change in Anxiety Scale for Children - Autism Spectrum Disorder - Parent Versions (ASC-ASD-P) Score | 24-item Parent/Caregiver-completed form developed to detect symptoms of anxiety in youth with ASD. Items are rated on a 4-point scale (0=never and 3=always). The total score is the sum of responses and ranges from 0 to 72; lower scores indicate lesser symptoms of anxiety. | Baseline, Week 6 |
| Anxiety Scale for Children - Autism Spectrum Disorder (ASC-ASD-C) - Child Version | 24-item Child-completed form developed to detect symptoms of anxiety in youth with ASD. Items are rated on a 4-point scale (0=never and 3=always). The total score is the sum of responses and ranges from 0 to 72; lower scores indicate lesser symptoms of anxiety. | Baseline, Week 6 |
| Change in Ohio State University (OSU) Autism Clinical Global Impressions: Severity | Reflects clinicians impression of severity of illness on a 7-point scale ranging from 1=not present to 7="classic" autism. | Baseline, Week 6 |
| OSU Autism Clinical Global Impressions: Improvement | Reflects clinicians impression of improvement on a 7-point scale ranging from 1=very much improved to 7=very much worse. | Week 6 |
| Change in Behavioral Inflexibility Scale (BIS) Score | 38-item Parent/Caregiver-completed measure designed to assess rigid patterns of behavior commonly associated with ASD. Items are rated on a 6-point Likert scale where 0=Not at all a problem and 5=Very severe or extreme problem. The total score is the sum of responses and ranges from 0 to 228; higher scores indicate greater behavioral inflexibility. | Baseline, Week 6 |
| Change in Home Situations Questionnaire - Modified for ASD (HSQ-ASD) Score | 24-item Parent/Caregiver-completed questionnaire measuring behavioral noncompliance in everyday settings over the past four weeks. Severity of non-compliance is rated on a 9-point Likert scale (where 1 = no interruption, and 9 = frequent/consistent interruption). The total score is the sum of responses and ranges from 24 to 216; higher scores indicate greater behavioral noncompliance. | Baseline, Week 6 |
| Change in Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior (SWAN) Score | SWAN is an 18-item Parent/Caregiver-completed measure designed to assess symptoms of ADHD in children and adolescents. Items are rated on a 7-point Likert scale, where Far Below Average = 3, Below Average = 2, Somewhat Below Average = 1, Average = 0, Somewhat Above Average = -1, Above Average = -2, and Far Above Average = -3. The total score is the sum of responses and ranges from -54 to 54; the lower the score, the higher the severity of ADHD symptoms. | Baseline, Week 6 |
| BG002 | 9 mg/kg 98% Pure CBD | Participants who received 98% pure CBD: 9 mg/kg/day in Part 2 of the study. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 9 mg/kg 98% Pure CBD | Participants who received 98% pure CBD: 9 mg/kg/day in Part 2 of the study. |
|
|
| Secondary | Change in Repetitive Behavior Scale-Revised (RBS-R) Score | The RBS-R is a 43-item self report used to measure the breadth of repetitive behavior in children. For each item, behaviors are rated on a 4-point scale: 0-Behavior does not occur, 1-Behavior occurs and is a mild problem, 2-Behavior occurs and is a moderate problem, 3-Behavior occurs and is a severe problem. On the last question, participants are asked to "lump together" all of the behaviors described in the questionnaire, and provide a rating for how much of a problem these repetitive behaviors are overall, on a scale from 1-100: 1-Not a problem at all, to 100-As bad as you can imagine. A decrease in scores indicates the repetitive behaviors became less of a problem overall. The total score is the sum of all items and ranges from 0 to 229. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 6 |
|
|
|
| Secondary | Change in Social Responsiveness Scale, 2nd Edition (SRS-2), School-Age Form Score | The SRS-2 is a 65-item questionnaire assessing Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests and Repetitive Behavior. Items are scored on a 4-point scale (ranging from 1=not true to 4=almost always true). The raw score is the sum of responses and is converted to a T-score; the final T-score has a mean of 50 points with a standard deviation of 10 points, where lower scores indicate greater social responsiveness:
| Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 6 |
|
|
|
| Secondary | Change in Aberrant Behavior Checklist (ABC) - Irritability Subscale Score | The ABC Irritability subscale comprises 15 items rated on a 4-point scale (ranging from 0=no problem at all to 3 = problem is severe in degree). The total score is the sum of responses and ranges from 0 to 45; higher scores indicate greater presences of irritability related behavior. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 6 |
|
|
|
| Secondary | Change in Screen for Child Anxiety Related Disorders (SCARED), Parent Version Score | The SCARED, Parent Version is a 41-item parent-report measure developed to measure child anxiety symptoms. Subscales include Somatic Symptoms/Panic Disorder, Generalized Anxiety Disorder, Separation Anxiety, Social Phobia, and School Phobia. Items are rated on a 3-point scale ranging from 0=not true or hardly ever true to 2=very true or often true. The total score is the sum of responses and ranges from 0 to 82; lower scores indicate lesser child anxiety symptoms. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 6 |
|
|
|
| Secondary | Change in Sleep Disturbance Scale for Children (SDSC) Score | The SDSC is a 26-item parent-completed assessment of their child's sleep-wake rhythm. The questionnaire measures Disorders of Initiating and Maintaining Sleep, Sleep Breathing Disorders, Disorders of Arousal, Sleep Wake Transition Disorders, Disorders of Excessive Somnolence, and Sleep Hyperhydrosis. Items are rated on 5-point scale where 1=never and 5=always (daily). The total score is the sum of responses and ranges from 26 to 130; lower scores indicate healthier sleep-wake rhythms. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 6 |
|
|
|
| Secondary | Change in Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) Parent/Caregiver Form Score | Used to measure adaptive functioning across three core domains (Communication, Daily Living Skills, and Socialization), and two optional domains (Motor Skills and Maladaptive Behavior); items are rated on a 3-point scale (0=never; 1=sometimes; 2=usually or often). The core domains sum to a total Adaptive Behavior Composite. The range of possible composite scores ranges from 20-140, with a higher score indicating higher levels of adaptive functioning. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 6 |
|
|
|
| Secondary | Change in Clinical Global Impression-Severity (CGI-S) Score | 1-item assessment of clinicians impression of severity of illness. Illness severity is rated on a 7-point scale ranging from 1=not at all to 7=among the most extremely ill. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 6 |
|
|
|
| Secondary | Change in Autism Family Experience Questionnaire (AFEQ) Score | Parent/Caregiver form used to measure impact of autism interventions on family experience and quality of life. Items are rated on a 5-point scale where 1=always and 5=never. The total score is the sum of responses and ranges from 48 - 240; lower scores indicate better outcomes. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 6 |
|
|
|
| Secondary | Change in Anxiety Scale for Children - Autism Spectrum Disorder - Parent Versions (ASC-ASD-P) Score | 24-item Parent/Caregiver-completed form developed to detect symptoms of anxiety in youth with ASD. Items are rated on a 4-point scale (0=never and 3=always). The total score is the sum of responses and ranges from 0 to 72; lower scores indicate lesser symptoms of anxiety. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 6 |
|
|
|
| Secondary | Anxiety Scale for Children - Autism Spectrum Disorder (ASC-ASD-C) - Child Version | 24-item Child-completed form developed to detect symptoms of anxiety in youth with ASD. Items are rated on a 4-point scale (0=never and 3=always). The total score is the sum of responses and ranges from 0 to 72; lower scores indicate lesser symptoms of anxiety. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 6 |
|
|
|
| Secondary | Change in Ohio State University (OSU) Autism Clinical Global Impressions: Severity | Reflects clinicians impression of severity of illness on a 7-point scale ranging from 1=not present to 7="classic" autism. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 6 |
|
|
|
| Secondary | OSU Autism Clinical Global Impressions: Improvement | Reflects clinicians impression of improvement on a 7-point scale ranging from 1=very much improved to 7=very much worse. | Posted | Mean | Standard Deviation | score on a scale | Week 6 |
|
|
|
| Secondary | Change in Behavioral Inflexibility Scale (BIS) Score | 38-item Parent/Caregiver-completed measure designed to assess rigid patterns of behavior commonly associated with ASD. Items are rated on a 6-point Likert scale where 0=Not at all a problem and 5=Very severe or extreme problem. The total score is the sum of responses and ranges from 0 to 228; higher scores indicate greater behavioral inflexibility. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 6 |
|
|
|
| Secondary | Change in Home Situations Questionnaire - Modified for ASD (HSQ-ASD) Score | 24-item Parent/Caregiver-completed questionnaire measuring behavioral noncompliance in everyday settings over the past four weeks. Severity of non-compliance is rated on a 9-point Likert scale (where 1 = no interruption, and 9 = frequent/consistent interruption). The total score is the sum of responses and ranges from 24 to 216; higher scores indicate greater behavioral noncompliance. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 6 |
|
|
|
| Secondary | Change in Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior (SWAN) Score | SWAN is an 18-item Parent/Caregiver-completed measure designed to assess symptoms of ADHD in children and adolescents. Items are rated on a 7-point Likert scale, where Far Below Average = 3, Below Average = 2, Somewhat Below Average = 1, Average = 0, Somewhat Above Average = -1, Above Average = -2, and Far Above Average = -3. The total score is the sum of responses and ranges from -54 to 54; the lower the score, the higher the severity of ADHD symptoms. | This outcome was not analyzed/assessed among participants in Part 1 of the trial (3 mg/kg and 6 mg/kg CBD arms). | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 6 |
|
|
|
| 0 |
| 0 |
| 0 |
| 6 |
| 6 |
| 6 |
| EG001 | 6 mg/kg 98% Pure CBD | Participants who received 98% pure CBD: 6 mg/kg/day in Part 1 of the study. | 0 | 0 | 0 | 9 | 8 | 9 |
| EG002 | 9 mg/kg 98% Pure CBD | Participants who received 98% pure CBD: 9 mg/kg/day in Part 2 of the study. | 0 | 0 | 0 | 8 | 6 | 8 |
| Increased Salivation | Endocrine disorders | Systematic Assessment |
|
| Dry mouth | Endocrine disorders | Systematic Assessment |
|
| Increased sweating | Endocrine disorders | Systematic Assessment |
|
| Appetite increase | Gastrointestinal disorders | Systematic Assessment |
|
| Appetite decrease | Gastrointestinal disorders | Systematic Assessment |
|
| Weight gain | General disorders | Systematic Assessment |
|
| Muscle aches | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Akathesia | Nervous system disorders | Systematic Assessment |
|
| Dystonia | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Increased stereotypies | Nervous system disorders | Systematic Assessment |
|
| Paresthesias | Nervous system disorders | Systematic Assessment |
|
| Rigidity | Nervous system disorders | Systematic Assessment |
|
| Asthenia | Psychiatric disorders | Systematic Assessment |
|
| Apathy | Psychiatric disorders | Systematic Assessment |
|
| Concentration difficulties | Psychiatric disorders | Systematic Assessment |
|
| Depressed Mood | Psychiatric disorders | Systematic Assessment |
|
| Emotionality | Psychiatric disorders | Systematic Assessment |
|
| Oppositionality | Psychiatric disorders | Systematic Assessment |
|
| Increased sleep duration | Psychiatric disorders | Systematic Assessment |
|
| Decreased sleep duration | Psychiatric disorders | Systematic Assessment |
|
| Sleepiness/Sedation | Psychiatric disorders | Systematic Assessment |
|
| Heavier Sleep | Psychiatric disorders | Systematic Assessment |
|
| Increased Dream Activity | Psychiatric disorders | Systematic Assessment |
|
| Sleep-onset Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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