Actigraphic Analysis of Treatment Response

NCT00723580 | Completed Results

• 1 other identifier: Act1
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep Disorders, Circadian Rhythm; Insomnia; Psychomotor Agitation

Keywords

Kabuki Syndrome; Actigraphy; Treatment Response Measurement

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• 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

Study Arms (1)

Sleep and Activity by Treatment Condition

EXPERIMENTAL

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.

Drug: risperidone

Interventions

risperidone DRUG

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.).

Also known as: Actigraphic measurements

Sleep and Activity by Treatment Condition

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Inability to wear actigraphy device

Sponsors & Collaborators

• Child Psychopharmacology Institute: lead

Study Sites (1)

Child Psychopharmacology Institute

Fargo, North Dakota, 58103, United States

Location

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm; Sleep Initiation and Maintenance Disorders; Psychomotor Agitation; Kabuki syndrome

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

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.

Results Point of Contact

• Title: Bill J. Duke, Ph.D.
• Organization: Child Psychopharmacology Institute

bduke@ChildPsychopharmacologyInstitute.org

701-241-9281

Study Officials

• Bill J Duke, M.A., Ph.D.

  Child Psychopharmacology Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 24, 2008
• First Posted: July 28, 2008
• Study Start: May 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 18, 2015
• Results First Posted: December 14, 2010

Record last verified: 2015-07

Locations

US (1)