Actigraphic Analysis of Treatment Response

Child Psychopharmacology Institute

Status: Completed

Conditions: Psychomotor Agitation; Insomnia; Sleep Disorders, Circadian Rhythm

Treatments: Drug: risperidone

Study type: Interventional

Funder types: Other

Identifiers

NCT00723580

Act1

Details and patient eligibility

About

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

Full 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.

Enrollment: 1 patient

Sex: Female

Ages: 2 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Kabuki Syndrome
• Medication Naive
• Single subject preparing to receive pharmacological intervention

Exclusion criteria

• Inability to wear actigraphy device

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Sleep and Activity by Treatment Condition

Experimental group

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.

Treatment:

Drug: risperidone