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Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT00723580
Date of registration:	24/07/2008
Prospective Registration:	No
Primary sponsor:	Child Psychopharmacology Institute
Public title:	Actigraphic Analysis of Treatment Response
Scientific title:	Actigraphic Analysis of Treatment Response in a Six Year Old Girl With Kabuki Syndrome
Date of first enrolment:	May 2008
Target sample size:	1
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT00723580
Study type:	Interventional
Study design:
Phase:	N/A

Countries of recruitment
United States

Contacts

Name:	Bill J Duke, M.A., Ph.D.
Address:
Telephone:
Email:
Affiliation:	Child Psychopharmacology Institute

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of Kabuki Syndrome

- Medication Naive

- Single subject preparing to receive pharmacological intervention

Exclusion Criteria:

- Inability to wear actigraphy device

Age minimum: 2 Years
Age maximum: 10 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Psychomotor Agitation

Insomnia

Sleep Disorders, Circadian Rhythm

Intervention(s)

Drug: risperidone

Primary Outcome(s)

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

Secondary Outcome(s)

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

The Personality Inventory for Children: Social Skills Scale [Time Frame: May-7-2008 to July -14-2010]

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

The Personality Inventory for Children: Adjustment Scale [Time Frame: May-7-2008 to July -14-2010]

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

The Personality Inventory for Children: Family Relations Scale [Time Frame: May-7-2008 to July -14-2010]

The Personality Inventory for Children: Delinquency Scale [Time Frame: May 7, 2008-July 14,2010]

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

The Personality Inventory for Children: Achievement Scale [Time Frame: May-7-2008 to July -14-2010]

The Personality Inventory for Children: Somatic-Physiological Scale [Time Frame: May-7-2008 to July -14-2010]

The Personality Inventory for Children: Withdrawal Scale [Time Frame: May-7-2008 to July -14-2010]

Secondary ID(s)

Act1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	14/12/2010
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT00723580

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