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Actigraphic Analysis of Treatment Response

This study has been completed.
Sponsor:
Information provided by:
Child Psychopharmacology Institute
ClinicalTrials.gov Identifier:
NCT00723580
First received: July 24, 2008
Last updated: December 17, 2010
Last verified: December 2010
Results First Received: September 22, 2010  
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
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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.)

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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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.)

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 ]

2.  Secondary:   Systematic Observation Scale Item: Percentage of Impulsivity Observed   [ Time Frame: May-7-2008 to July -14-2010 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Systematic Observation Scale: Percentage of Irritability Observed   [ Time Frame: May-7-2008 to July -14-2010 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Systematic Observation Scale: Percentage of Distractibility Observed   [ Time Frame: May-7-2008 to July -14-2010 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Systematic Observation Scale: Percentage of Hyperactivity Observed   [ Time Frame: May-7-2008 to July -14-2010 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   The Personality Inventory for Children: Adjustment Scale   [ Time Frame: May-7-2008 to July -14-2010 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   The Personality Inventory for Children: Achievement Scale   [ Time Frame: May-7-2008 to July -14-2010 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   The Personality Inventory for Children: Somatic-Physiological Scale   [ Time Frame: May-7-2008 to July -14-2010 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   The Personality Inventory for Children: Delinquency Scale   [ Time Frame: May 7, 2008-July 14,2010 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   The Personality Inventory for Children: Withdrawal Scale   [ Time Frame: May-7-2008 to July -14-2010 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   The Personality Inventory for Children: Social Skills Scale   [ Time Frame: May-7-2008 to July -14-2010 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

12.  Secondary:   The Personality Inventory for Children: Family Relations Scale   [ Time Frame: May-7-2008 to July -14-2010 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This single case study has limited generalizability in that these results may not apply to others. The methods explored, however, may apply to others and Single-subject repeated measurements can provide valuable clinical and scientific data.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Bill J. Duke, Ph.D.
Organization: Child Psychopharmacology Institute
phone: 701-241-9281 ext 2
e-mail: bduke@ChildPsychopharmacologyInstitute.org


No publications provided


Responsible Party: Bill J. Duke, M.A., Ph.D., ABMPP, Child Psychopharmacology Institute
ClinicalTrials.gov Identifier: NCT00723580     History of Changes
Other Study ID Numbers: Act1
Study First Received: July 24, 2008
Results First Received: September 22, 2010
Last Updated: December 17, 2010
Health Authority: United States: Institutional Review Board