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OpenTrials
Completed

NCT Number: NCT01184235

Multidimensional Measurement of Psychopharmacological Treatment Response

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

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Key information

Conditions

Autism Spectrum Disorders Attention Deficit Disorder with Hyperactivity Attention Deficit Disorders Attention Deficit and Disruptive Behavior Disorders Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Mood Disorders Nervous System Diseases Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders Sleep Wake Disorders

Age range

6 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Child Psychopharmacology Institute

Fargo, North Dakota, 58103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmacological Intervention

Drug

This study will include those anticipating or receiving any pharmacological intervention

Other names: antipsychotics, antidepressants, mood stabilizers, stimulants, NMDA antagonists

Primary outcomes

  1. Actigraphic Measurement

    Time frame: Three week actigraphic measurement periods

    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 outcomes

  1. Operationally Defined Observations

    Time frame: Randomly repeated treatment course observational measurements during actigraphic measurement periods

    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.

Sponsors and collaborators

Lead sponsor

Child Psychopharmacology Institute

Other

Registry information

Official study title

Actigraphic, Observational, Psychometric and Biological Measurement of Psychopharmacological Treatment Response

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 18, 2010
Registry last updated
Jan 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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