Actigraphic Analysis of Treatment Response - Study Results

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Health Services Research
Conditions:	Sleep Disorders, Circadian Rhythm Insomnia Psychomotor Agitation
Intervention:	Drug: risperidone

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A six year old child with Autism Spectrum Disorder (pervasive developmental disorder) and Kabuki Syndrome anticipating a pharmacological intervention was evaluated for sleep and behavioral disturbances. She was invited to participate, her parents provided consent and the child acknowledged her assent.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The child had previously not responded to multiple medication trials, was stimulated by diphenylhydramine, over-sedated on clonidine and had mood destabilization when tried on mirtazapine. The child received no medication for the month preceding the initiation of the study.

Reporting Groups

	Description
Actigraphic (Activity Count) Measurement of Sleep and Activity	Actigraphic measurements obtained by attaching an actigraphic watch device to the child's non-dominant wrist obtain measurements that occur every thirty seconds for a duration of approximately 21 days. These measurements reflect treatment condition sleep characteristics where sleep is indicated by activity counts below 40. Three 21 day actigraphic measurement periods occurred with the initial measurement occurring through baseline period and the period in which the child's pharmacological treatment was initiated. The second and third, 21 day periods of Actigraphic measurement occurred at 22 and 23 months from baseline. Five treatment conditions during the measurement periods including 1. baseline no medication 2. risperidone .25 mg at bedtime for 7 days (q.h.s.) 3. risperidone twice daily (b.i.d.) 4. risperidone .25 mg three times a day (t.i.d.) and 5. risperidone .50 mg three times a day (t.i.d.)

Description

Actigraphic (Activity Count) Measurement of Sleep and Activity

Actigraphic measurements obtained by attaching an actigraphic watch device to the child's non-dominant wrist obtain measurements that occur every thirty seconds for a duration of approximately 21 days. These measurements reflect treatment condition sleep characteristics where sleep is indicated by activity counts below 40. Three 21 day actigraphic measurement periods occurred with the initial measurement occurring through baseline period and the period in which the child's pharmacological treatment was initiated. The second and third, 21 day periods of Actigraphic measurement occurred at 22 and 23 months from baseline. Five treatment conditions during the measurement periods including 1. baseline no medication 2. risperidone .25 mg at bedtime for 7 days (q.h.s.) 3. risperidone twice daily (b.i.d.) 4. risperidone .25 mg three times a day (t.i.d.) and 5. risperidone .50 mg three times a day (t.i.d.)

Participant Flow: Overall Study

	Actigraphic (Activity Count) Measurement of Sleep and Activity
STARTED	1 ^[1]
Baseline Measurements	1 ^[2]
COMPLETED	1 ^[3]
NOT COMPLETED	0

[1]	Study was extended with continued repeated measurements.
[2]	Actigraphic, Psychometric and Observational Baseline Data Collected.
[3]	Completion of repeated Measurements

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Actigraphic (Activity Count) Measurement of Sleep and Activity	Actigraphic measurements obtained by attaching an actigraphic watch device to the child's non-dominant wrist obtain measurements that occur every thirty seconds for a duration of approximately 21 days. These measurements reflect treatment condition sleep characteristics where sleep is indicated by activity counts below 40. Three 21 day actigraphic measurement periods occurred with the initial measurement occurring through baseline period and the period in which the child's pharmacological treatment was initiated. The second and third, 21 day periods of Actigraphic measurement occurred at 22 and 23 months from baseline. Five treatment conditions during the measurement periods including 1. baseline no medication 2. risperidone .25 mg at bedtime for 7 days (q.h.s.) 3. risperidone twice daily (b.i.d.) 4. risperidone .25 mg three times a day (t.i.d.) and 5. risperidone .50 mg three times a day (t.i.d.)

Description

Actigraphic (Activity Count) Measurement of Sleep and Activity

Actigraphic measurements obtained by attaching an actigraphic watch device to the child's non-dominant wrist obtain measurements that occur every thirty seconds for a duration of approximately 21 days. These measurements reflect treatment condition sleep characteristics where sleep is indicated by activity counts below 40. Three 21 day actigraphic measurement periods occurred with the initial measurement occurring through baseline period and the period in which the child's pharmacological treatment was initiated. The second and third, 21 day periods of Actigraphic measurement occurred at 22 and 23 months from baseline. Five treatment conditions during the measurement periods including 1. baseline no medication 2. risperidone .25 mg at bedtime for 7 days (q.h.s.) 3. risperidone twice daily (b.i.d.) 4. risperidone .25 mg three times a day (t.i.d.) and 5. risperidone .50 mg three times a day (t.i.d.)

Baseline Measures

	Actigraphic (Activity Count) Measurement of Sleep and Activity
Number of Participants [units: participants]	1
Age [units: participants]
<=18 years	1
Age [units: years] Mean ± Standard Deviation	6 ± 0
Gender [units: participants]
Female	1
Region of Enrollment [units: participants]
United States	1

Outcome Measures

1. Primary:

Actigraphic Measurement of Treatment Conditions [ Time Frame: May 12- July 14, 2010 ]

Show Outcome Measure 1

2. Secondary:

Systematic Observation Scale Item: Percentage of Impulsivity Observed [ Time Frame: May-7-2008 to July -14-2010 ]