Multidimensional Measurement of Psychopharmacological Treatment Response

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Child Psychopharmacology Institute
ClinicalTrials.gov Identifier:
NCT01184235
First received: August 12, 2010
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

The study examines actigraphic, observational, psychometric and associated repeated measurements obtained prior to and during psychopharmacological treatment.


Condition Intervention
Autism Spectrum Disorders
Mood Disorders
Sleep Disorders
Attention Deficit Disorders
Drug: Pharmacological Intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Actigraphic, Observational, Psychometric and Biological Measurement of Psychopharmacological Treatment Response

Resource links provided by NLM:


Further study details as provided by Child Psychopharmacology Institute:

Primary Outcome Measures:
  • Actigraphic Measurement [ Time Frame: Three week actigraphic measurement periods ] [ Designated as safety issue: No ]
    Actigraphic measurements are recorded every 30 seconds during three week measurement periods. The actigraphic measurements will be made utilizing an Actiwatch (AW-64 Phillips-Rispironics, Inc.), placed on the subject's non-dominant wrist. The measurements will occur every thirty seconds for approximately 21 consecutive days. Actigraphic measurements collected at this frequency reflect circadian patterns of interest; discern sleep states and characterize activity and activity patterns.


Secondary Outcome Measures:
  • Operationally Defined Observations [ Time Frame: Randomly repeated treatment course observational measurements during actigraphic measurement periods ] [ Designated as safety issue: No ]
    The Systematic Observation Scale™ utilizes operationally defined symptoms that are presented to the primary observer (self or parent) for determination regarding the percentage of time symptoms are present. Target symptoms will be defined at baseline. Systematic Observation Scale measurements will be obtained at baseline and weekly post-treatment for periods defined as treatment initiation, treatment adjustment or treatment-course longitudinal.


Enrollment: 44
Study Start Date: August 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Autism Spectrum Disorders
This group will include those receiving or anticipating receiving pharmacological intervention whose primary diagnosis is Autism Spectrum Disorder
Drug: Pharmacological Intervention
This study will include those anticipating or receiving any pharmacological intervention
Other Names:
  • antipsychotics
  • antidepressants
  • mood stabilizers
  • stimulants
  • NMDA antagonists
Attention Deficit Hyperactivity Disorder
This group will include those receiving or anticipating receiving pharmacological intervention whose primary diagnosis is Attention Deficit Hyperactivity Disorder.
Drug: Pharmacological Intervention
This study will include those anticipating or receiving any pharmacological intervention
Other Names:
  • antipsychotics
  • antidepressants
  • mood stabilizers
  • stimulants
  • NMDA antagonists
Unaffected 1st Degree Relatives
This group will include unaffected, non treated first degree relatives of this study's subjects receiving or anticipating receiving pharmacological intervention.
Mood Disorders
This group will include those receiving or anticipating receiving pharmacological intervention whose primary diagnosis is mood disorder.
Drug: Pharmacological Intervention
This study will include those anticipating or receiving any pharmacological intervention
Other Names:
  • antipsychotics
  • antidepressants
  • mood stabilizers
  • stimulants
  • NMDA antagonists

Detailed Description:

Baseline actigraphic measurements, multi-symptom operationally defined observations and psychometric data will be established and repeated to measure treatment response. Additional biological and biometric measures that have potential to further characterize the cohorts under study or treatment response will be collected as practical and when possible.

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children and adults, male or female receiving or anticipating pharmacological intervention and their non-affected first degree relatives will be invited to participate based on institutional actiwatch availability. Since children are the focus of the Child Psychopharmacology Institute they will be the primary recruitment focus, however, adult subjects may include non-affected first degree relatives or others who represent designated cohort groups and will be accepted based on actiwatch availabilty.

Criteria

Inclusion Criteria:

  • Diagnosis of:
  • Autism Spectrum Disorder
  • Mood Disorder
  • Attention Deficit Hyperactivity Disorder
  • Unaffected First Degree Relative of Study Subject
  • Anticipation of pharmacological intervention or current pharmacological intervention

Exclusion Criteria:

Inability to wear an actigraphy watch

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01184235

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
Principal Investigator: Robert D Staton, Ph.D., M.D. Child Psychopharmacology Institute
  More Information

No publications provided

Responsible Party: Child Psychopharmacology Institute
ClinicalTrials.gov Identifier: NCT01184235     History of Changes
Other Study ID Numbers: Act3
Study First Received: August 12, 2010
Last Updated: January 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Child Psychopharmacology Institute:
Circadian Disorders
Autism Spectrum Disorders
Mood Disorders
Executive Functioning
Pediatric Mood Disorders

Additional relevant MeSH terms:
Autistic Disorder
Sleep Disorders
Parasomnias
Attention Deficit Disorder with Hyperactivity
Mood Disorders
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Attention Deficit and Disruptive Behavior Disorders
Antidepressive Agents
Antipsychotic Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014