Actigraphic Analysis of Treatment Response

Actigraphic Analysis of Treatment Response in a Six Year Old Girl With Kabuki Syndrome

Sponsors

Lead Sponsor: Child Psychopharmacology Institute

Source Child Psychopharmacology Institute
Brief Summary

The study examines and illustrates the utility of utilizing actigraphic measurements to assess treatment response.

Detailed Description

Actigraphic measurements will be recorded every 30 seconds and will be recorded for an 11 day baseline period, followed by a 10 day period of the initial pharmacological interventions. The non-invasive nature of watch-like actigraphy devices is particularly attractive for use in pediatric populations. Meaningful treatment response measurements are obtained when actigraphic data is combined with psychometric and observational repeated measurements. Subsequent to the initial data collection the parent consented and the child assented to extend the study and continue measurements. The case study included baseline and repeated psychological, observational and actigraphic measurements that were initiated prior to treatment with risperidone and repeated throughout the treatment process with the final data collected in July 2010. The Personality Inventory for Children (PIC) is an objective multidimensional measurement of affect, behavior, ability and family function. The PIC was administered prior to treatment with risperidone and repeated after 22 months of treatment. The PIC serves as both an actuarial pre-treatment diagnostic tool as well as a post-treatment repeated measurement indicating treatment associated change. A primary observer (mother) was trained to report symptom percentages present since previous observations utilizing the operationally defined and observer defined items of the systematic observation scale throughout the treatment process. Actigraphic measurements provide a basis by which to measure sleep and sleep onset latency as well as periods of mobility and immobility. When programmed to record activity every thirty seconds, thousands of measurements are quickly captured. Actigraphic measurements were made utilizing a watch-like actigraphic device with an 11 day baseline actigraphic measurement period and continued measurements that included the initiation of a Once-Daily, Bedtime (q.h.s.) pharmacological intervention for 6 days, followed by a planned adjustment to Twice a Day (b.i.d.) dosing that was measured for an additional 4 days. Repeated actigraphic studies were subsequently conducted after 22 months of risperidone treatment and were collected along with the repeated observational and psychometric data. This case study explores activity and sleep characteristics related to behavioral characteristics and treatment response and the utility of single subject repeated actigraphic, psychometric and observational measurements and monitoring of treatment response.

Overall Status Completed
Start Date 2008-05-01
Completion Date 2010-08-01
Primary Completion Date 2010-07-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Actigraphic Measurement of Treatment Conditions May 12- July 14, 2010
Secondary Outcome
Measure Time Frame
Systematic Observation Scale Item: Percentage of Impulsivity Observed May-7-2008 to July -14-2010
Systematic Observation Scale: Percentage of Irritability Observed May-7-2008 to July -14-2010
Systematic Observation Scale: Percentage of Distractibility Observed May-7-2008 to July -14-2010
Systematic Observation Scale: Percentage of Hyperactivity Observed May-7-2008 to July -14-2010
The Personality Inventory for Children: Adjustment Scale May-7-2008 to July -14-2010
The Personality Inventory for Children: Achievement Scale May-7-2008 to July -14-2010
The Personality Inventory for Children: Somatic-Physiological Scale May-7-2008 to July -14-2010
The Personality Inventory for Children: Delinquency Scale May 7, 2008-July 14,2010
The Personality Inventory for Children: Withdrawal Scale May-7-2008 to July -14-2010
The Personality Inventory for Children: Social Skills Scale May-7-2008 to July -14-2010
The Personality Inventory for Children: Family Relations Scale May-7-2008 to July -14-2010
Enrollment 1
Condition
Intervention

Intervention Type: Drug

Intervention Name: risperidone

Description: Five treatment conditions: 1. Baseline no medication 2. Risperidone .25 mg at bedtime (q.h.s.) x 7 days 3. Risperidone .25 mg twice daily (b.i.d.) 4. Risperidone .25 mg three times a day (t.i.d.) and 5. Risperidone .5 mg three times a day (t.i.d.).

Arm Group Label: Sleep and Activity by Treatment Condition

Other Name: Actigraphic measurements

Eligibility

Criteria:

Inclusion Criteria: - Diagnosis of Kabuki Syndrome - Medication Naive - Single subject preparing to receive pharmacological intervention Exclusion Criteria: - Inability to wear actigraphy device

Gender:

Female

Minimum Age:

2 Years

Maximum Age:

10 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Bill J Duke, M.A., Ph.D. Principal Investigator Child Psychopharmacology Institute
Location
Facility: Child Psychopharmacology Institute
Location Countries

United States

Verification Date

2015-07-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Child Psychopharmacology Institute

Investigator Full Name: Bill J. Duke, M.A., Ph.D., ABMPP

Investigator Title: Director

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Sleep and Activity by Treatment Condition

Type: Experimental

Description: Actigraphic measurements were obtained by attaching an actigraphic watch device to the child's non-dominant wrist. The measurements will include three separate three week periods beginning with a baseline period and the period in which the child's pharmacological treatment was initiated. Two additional three week actigraphic measurement periods will occur at 22 months post-baseline period and at 23 months post-baseline period. The resulting five treatment conditions were: 1. Baseline no medication 2. Risperidone .25 mg at bedtime (q.h.s.) x 7 days 3. Risperidone .25 mg twice daily (b.i.d.) 4. Risperidone .25 mg three times a day (t.i.d.) and 5. Risperidone .5 mg three times a day (t.i.d.). Sleep and activity will be evaluated by treatment conditions.

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Health Services Research

Masking: None (Open Label)

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