Covid 19 Research using Clinical Trials (Home Page)
Report for D011595: Psychomotor Agitation NIH
(Synonyms: Psychomotor Agitation)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (5)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug97 | AVP-786 Wiki | 1.00 |
| drug2031 | Ravulizumab Wiki | 0.71 |
| drug315 | Baricitinib Wiki | 0.38 |
| drug2326 | Standard of care Wiki | 0.23 |
| drug1822 | Placebo Wiki | 0.06 |
There is one clinical trial.
Clinical Trials
1 A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Patients With Traumatic Brain Injury (TBI).
This is a multicenter, randomized, placebo-controlled study to evaluate AVP-786 for the treatment of neurobehavioral disinhibition including aggression, agitation, and irritability in participants with traumatic brain injury (TBI).
NCT03095066 Neurobehavioral Disinhibition Drug: AVP-786 Drug: Placebo MeSH:Brain Injuries Brain Injuries, Traumatic Psychomotor Agitation Aggression
HPO:Aggressive behavior
Primary Outcomes
Description: The NPI-C can be used to rate the presence of neuropsychiatric symptoms across 14 domains. The scores for each item within an individual domain/subscale range from 0 to 3, with a higher score indicating increased severity. The NPI-C-3 is comprised of the aggression, agitation, and irritability/lability subscales. The scores for the three subscales are summed to create the total NPI-C-3 composite score, which ranges from 0 to 99, with a higher score indicating increased severity.
Measure: Change from Baseline to Week 12 in the Composite of the Clinical Impression Severity Scores on the Neuropsychiatric Inventory Clinician Rating Scale (NPI-C) Subscales of Aggression, Agitation, and Irritability/Lability (NPI-C-3) Time: Baseline; Week 12
Secondary Outcomes
Description: The mCGI-C will be used to assess the clinician's general impression of the participant's treatment response. The mCGI-C is a 7-point (1 to 7) modified version of the CGI-C scale. A higher score represents worsening of symptoms.
Measure: Change from Baseline to Week 12 in Modified Clinical Global Impression of Change (mCGI-C) Raw Scores Time: Baseline; Week 12
Description: The NPI-C is used to rate the presence of neuropsychiatric symptoms across 14 domains. The scores for each item within an individual domain/subscale range from 0 to 3, with a higher score indicating increased severity.
Measure: Change from Baseline to Week 12 in NPI-C Rating Scale Subscales Scores for Aggression, Agitation, Irritability/Lability, and Disinhibition Time: Baseline; Week 12
Description: The mCGI-S will be used to assess the clinician's view of the participant's severity of aggression, agitation, and irritability symptoms. The mCGI-S is a 7-point (1 to 7) modified version of the CGI-S scale. In all cases, a higher score represents increased severity.
Measure: Change from Baseline to Week 12 in Modified Clinical Global Impression of Severity (mCGI-S) Scale Scores Time: Baseline; Week 12
Description: The PGI-S is a single-question scale that specifically assesses the severity of symptoms of neurobehavioral disinhibition, including aggression, agitation, and irritability, on a 7-point scale : 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Measure: Change from Baseline to Week 12 in Patient Global Impression of Severity (PGI-S) Scores Time: Baseline; Week 12
Description: The PGI-C is a 7-point (1 to 7) scale used to assess the participant's assessment of treatment response. A higher score indicates worsening of the symptoms.
Measure: Change from Baseline to Week 12 in Patient Global Impression of Change (PGI-C) Raw Scores Time: Baseline; Week 12
HPO Nodes
Primary Outcomes
Description: The NPI-C can be used to rate the presence of neuropsychiatric symptoms across 14 domains. The scores for each item within an individual domain/subscale range from 0 to 3, with a higher score indicating increased severity. The NPI-C-3 is comprised of the aggression, agitation, and irritability/lability subscales. The scores for the three subscales are summed to create the total NPI-C-3 composite score, which ranges from 0 to 99, with a higher score indicating increased severity.
Measure: Change from Baseline to Week 12 in the Composite of the Clinical Impression Severity Scores on the Neuropsychiatric Inventory Clinician Rating Scale (NPI-C) Subscales of Aggression, Agitation, and Irritability/Lability (NPI-C-3) Time: Baseline; Week 12Secondary Outcomes
Description: The mCGI-C will be used to assess the clinician's general impression of the participant's treatment response. The mCGI-C is a 7-point (1 to 7) modified version of the CGI-C scale. A higher score represents worsening of symptoms.
Measure: Change from Baseline to Week 12 in Modified Clinical Global Impression of Change (mCGI-C) Raw Scores Time: Baseline; Week 12Description: The NPI-C is used to rate the presence of neuropsychiatric symptoms across 14 domains. The scores for each item within an individual domain/subscale range from 0 to 3, with a higher score indicating increased severity.
Measure: Change from Baseline to Week 12 in NPI-C Rating Scale Subscales Scores for Aggression, Agitation, Irritability/Lability, and Disinhibition Time: Baseline; Week 12Description: The mCGI-S will be used to assess the clinician's view of the participant's severity of aggression, agitation, and irritability symptoms. The mCGI-S is a 7-point (1 to 7) modified version of the CGI-S scale. In all cases, a higher score represents increased severity.
Measure: Change from Baseline to Week 12 in Modified Clinical Global Impression of Severity (mCGI-S) Scale Scores Time: Baseline; Week 12Description: The PGI-S is a single-question scale that specifically assesses the severity of symptoms of neurobehavioral disinhibition, including aggression, agitation, and irritability, on a 7-point scale : 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Measure: Change from Baseline to Week 12 in Patient Global Impression of Severity (PGI-S) Scores Time: Baseline; Week 12Description: The PGI-C is a 7-point (1 to 7) scale used to assess the participant's assessment of treatment response. A higher score indicates worsening of the symptoms.
Measure: Change from Baseline to Week 12 in Patient Global Impression of Change (PGI-C) Raw Scores Time: Baseline; Week 12