N/A
N=1
Actigraphic Analysis of Treatment Response
Sleep Disorders, Circadian Rhythm · Insomnia · Psychomotor Agitation
Bottom Line
View on ClinicalTrials.gov: NCT00723580 ↗Enrolled (actual)
1
Serious AEs
0.0%
Results posted
Dec 2010
Primary outcome: Primary: Actigraphic Measurement of Treatment Conditions — 55.02; 9.94 activity
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- risperidone (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- Female
- Sponsor
- Child Psychopharmacology Institute
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Actigraphic Measurement of Treatment Conditions |
55.02; 9.94 | — |
| SECONDARY Systematic Observation Scale Item: Percentage of Impulsivity Observed |
— | — |
| SECONDARY Systematic Observation Scale: Percentage of Irritability Observed |
— | — |
| SECONDARY Systematic Observation Scale: Percentage of Distractibility Observed |
— | — |
| SECONDARY Systematic Observation Scale: Percentage of Hyperactivity Observed |
— | — |
| SECONDARY The Personality Inventory for Children: Adjustment Scale |
— | — |
| SECONDARY The Personality Inventory for Children: Achievement Scale |
— | — |
| SECONDARY The Personality Inventory for Children: Somatic-Physiological Scale |
— | — |
| SECONDARY The Personality Inventory for Children: Delinquency Scale |
— | — |
| SECONDARY The Personality Inventory for Children: Withdrawal Scale |
— | — |
| SECONDARY The Personality Inventory for Children: Social Skills Scale |
— | — |
| SECONDARY The Personality Inventory for Children: Family Relations Scale |
— | — |
Summary
The study examines and illustrates the utility of utilizing actigraphic measurements to assess treatment response.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Kabuki Syndrome
- Medication Naive
- Single subject preparing to receive pharmacological intervention
Exclusion Criteria
- Inability to wear actigraphy device
Data sourced from ClinicalTrials.gov (NCT00723580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.