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
  Purpose

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


Condition Intervention
Sleep Disorders, Circadian Rhythm
Insomnia
Psychomotor Agitation
Drug: risperidone

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Actigraphic Analysis of Treatment Response in a Six Year Old Girl With Kabuki Syndrome

Resource links provided by NLM:


Further study details as provided by Child Psychopharmacology Institute:

Primary Outcome Measures:
  • Actigraphic Measurement of Treatment Conditions [ Time Frame: May 12- July 14, 2010 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Systematic Observation Scale Item: Percentage of Impulsivity Observed [ Time Frame: May-7-2008 to July -14-2010 ] [ Designated as safety issue: No ]
    The Systematic Observation Scale utilizes single-subject repeated measurements. Symptoms and issues of interest are defined and a variety of frequency and sampling methods can be applied. The Systematic Observation Scale was designed so Primary Observers (parents, guardians, self observers or others) can make pre-treatment and subsequent observations to track, document and evaluate symptom variation over the course of an illness. The measurement utilized is the percentage of time the symptom is observed by the primary observer since the previous observation.

  • Systematic Observation Scale: Percentage of Irritability Observed [ Time Frame: May-7-2008 to July -14-2010 ] [ Designated as safety issue: No ]
  • Systematic Observation Scale: Percentage of Distractibility Observed [ Time Frame: May-7-2008 to July -14-2010 ] [ Designated as safety issue: No ]
  • Systematic Observation Scale: Percentage of Hyperactivity Observed [ Time Frame: May-7-2008 to July -14-2010 ] [ Designated as safety issue: No ]
  • The Personality Inventory for Children: Adjustment Scale [ Time Frame: May-7-2008 to July -14-2010 ] [ Designated as safety issue: No ]
    This scale measures general personality adjustment reflecting a dimension associated with highly adaptive to maladaptive adjustment. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function. The PIC was administered prior to treatment with risperidone and repeated after 22 months of treatment. The PIC serves as both an actuarial pre-treatment diagnostic tool as well as a post-treatment repeated measurement indicating treatment and developmentally associated change.

  • The Personality Inventory for Children: Achievement Scale [ Time Frame: May-7-2008 to July -14-2010 ] [ Designated as safety issue: No ]
    The factors that underlie this scale are academic ability, poor achievement, impulsivity, limited concentration and over or under-assertiveness with peers. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.

  • The Personality Inventory for Children: Somatic-Physiological Scale [ Time Frame: May-7-2008 to July -14-2010 ] [ Designated as safety issue: No ]
    The factors that underlie this scale are fatigue, aches and pains, insomnia, somatic response to stress and malingering. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.

  • The Personality Inventory for Children: Delinquency Scale [ Time Frame: May 7, 2008-July 14,2010 ] [ Designated as safety issue: No ]
    The factors that underlie this scale are poor frustration tolerance, irritability, sadness, lack of interest, hostility,limited social participation and resistance to authority. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.

  • The Personality Inventory for Children: Withdrawal Scale [ Time Frame: May-7-2008 to July -14-2010 ] [ Designated as safety issue: No ]
    The factors that underlie this scale are physical isolation, Shyness, isolation from peers, emotional distance and isolated intellectual interests. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function

  • The Personality Inventory for Children: Social Skills Scale [ Time Frame: May-7-2008 to July -14-2010 ] [ Designated as safety issue: No ]
    The factors that underlie this scale are social success, social rejection, adults as only social contacts, and the ability to lead and follow. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.

  • The Personality Inventory for Children: Family Relations Scale [ Time Frame: May-7-2008 to July -14-2010 ] [ Designated as safety issue: No ]
    The factors that underlie this scale are family stability, inter-parent communication, presence of love and happiness in the home and appropriateness of discipline. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.


Enrollment: 1
Study Start Date: May 2008
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sleep and Activity by Treatment Condition
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
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.).
Other Name: Actigraphic measurements

Detailed Description:

Actigraphic measurements will be recorded every 30 seconds and will be recorded for an 11 day baseline period, followed by a 10 day period of the initial pharmacological interventions. The non-invasive nature of watch-like actigraphy devices is particularly attractive for use in pediatric populations. Meaningful treatment response measurements are obtained when actigraphic data is combined with psychometric and observational repeated measurements. Subsequent to the initial data collection the parent consented and the child assented to extend the study and continue measurements.

The case study included baseline and repeated psychological, observational and actigraphic measurements that were initiated prior to treatment with risperidone and repeated throughout the treatment process with the final data collected in July 2010.

The Personality Inventory for Children (PIC) is an objective multidimensional measurement of affect, behavior, ability and family function. The PIC was administered prior to treatment with risperidone and repeated after 22 months of treatment. The PIC serves as both an actuarial pre-treatment diagnostic tool as well as a post-treatment repeated measurement indicating treatment associated change.

A primary observer (mother) was trained to report symptom percentages present since previous observations utilizing the operationally defined and observer defined items of the systematic observation scale throughout the treatment process.

Actigraphic measurements provide a basis by which to measure sleep and sleep onset latency as well as periods of mobility and immobility. When programmed to record activity every thirty seconds, thousands of measurements are quickly captured.

Actigraphic measurements were made utilizing a watch-like actigraphic device with an 11 day baseline actigraphic measurement period and continued measurements that included the initiation of a Once-Daily, Bedtime (q.h.s.) pharmacological intervention for 6 days, followed by a planned adjustment to Twice a Day (b.i.d.) dosing that was measured for an additional 4 days. Repeated actigraphic studies were subsequently conducted after 22 months of risperidone treatment and were collected along with the repeated observational and psychometric data.

This case study explores activity and sleep characteristics related to behavioral characteristics and treatment response and the utility of single subject repeated actigraphic, psychometric and observational measurements and monitoring of treatment response.

  Eligibility

Ages Eligible for Study:   2 Years to 10 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Inability to wear actigraphy device
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00723580

Locations
United States, North Dakota
Child Psychopharmacology Institute
Fargo, North Dakota, United States, 58103
Sponsors and Collaborators
Child Psychopharmacology Institute
Investigators
Principal Investigator: Bill J Duke, M.A., Ph.D. Child Psychopharmacology Institute
  More Information

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

Keywords provided by Child Psychopharmacology Institute:
Kabuki Syndrome
Actigraphy
Treatment Response Measurement

Additional relevant MeSH terms:
Sleep Disorders, Circadian Rhythm
Sleep Disorders
Parasomnias
Psychomotor Agitation
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Dyskinesias
Psychomotor Disorders
Neurobehavioral Manifestations
Chronobiology Disorders
Dyssomnias
Occupational Diseases
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on April 15, 2014