Multidimensional Measurement of Psychopharmacological Treatment Response

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

Detailed Description
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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.

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

Conditions
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Autism Spectrum Disorders, Mood Disorders, Sleep Disorders, Attention Deficit Disorders

Intervention / Treatment
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* Drug: Pharmacological Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Autism Spectrum Disorders<br>This group will include those receiving or anticipating receiving pharmacological intervention whose primary diagnosis is Autism Spectrum Disorder | Drug: Pharmacological Intervention<br>* This study will include those anticipating or receiving any pharmacological intervention<br>* Other names: NMDA antagonists;|
| Attention Deficit Hyperactivity Disorder<br>This group will include those receiving or anticipating receiving pharmacological intervention whose primary diagnosis is Attention Deficit Hyperactivity Disorder. | Drug: Pharmacological Intervention<br>* This study will include those anticipating or receiving any pharmacological intervention<br>* Other names: NMDA antagonists;|
| Unaffected 1st Degree Relatives<br>This group will include unaffected, non treated first degree relatives of this study's subjects receiving or anticipating receiving pharmacological intervention. | |
| Mood Disorders<br>This group will include those receiving or anticipating receiving pharmacological intervention whose primary diagnosis is mood disorder. | Drug: Pharmacological Intervention<br>* This study will include those anticipating or receiving any pharmacological intervention<br>* Other names: NMDA antagonists;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Actigraphic Measurement | 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. | Three week actigraphic measurement periods | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operationally Defined Observations | 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. | Randomly repeated treatment course observational measurements during actigraphic measurement periods | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Circadian Disorders, Autism Spectrum Disorders, Mood Disorders, Executive Functioning, Pediatric Mood Disorders