NCT00723580|CompletedResults
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Sponsor study identifier
interventional
1
1 country
1
Study Start
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2010
Actual (reported)Study Completion
August 2010
Actual (reported)The study examines and illustrates the utility of utilizing actigraphic measurements to assess treatment response.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
July 24, 2008
Actual (reported)July 28, 2008
Actual (reported)July 2010
Actual (reported)August 2010
Actual (reported)December 14, 2010
Actual (reported)Actigraphic Measurement of Treatment Conditions
The child's impulsivity and inability to sleep represented a significant symptom and risk factor. Impulsivity and sleep will be actigraphically assessed by treatment conditions.
May 12- July 14, 2010
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
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.
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.).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Child Psychopharmacology Institute
Fargo, North Dakota, 58103, United States
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.
Bill J Duke, M.A., Ph.D.
Child Psychopharmacology Institute
1 participants (actual enrollment reported by the registry).
First Submitted
July 24, 2008
First Posted
July 28, 2008
Study Start
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
July 2010
Actual (reported)Study Completion
August 2010
Actual (reported)Last Updated
August 18, 2015
Results First Posted
December 14, 2010
Record last verified: 2015-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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