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The study examines actigraphic, observational, psychometric and associated repeated measurements obtained prior to and during psychopharmacological treatment.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autism Spectrum Disorders | This group will include those receiving or anticipating receiving pharmacological intervention whose primary diagnosis is Autism Spectrum Disorder |
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| Attention Deficit Hyperactivity Disorder | This group will include those receiving or anticipating receiving pharmacological intervention whose primary diagnosis is Attention Deficit Hyperactivity Disorder. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacological Intervention | Drug | This study will include those anticipating or receiving any pharmacological intervention |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Inability to wear an actigraphy watch
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bill J Duke, M.A., Ph.D. | Child Psychopharmacology Institute | Principal Investigator |
| Robert D Staton, Ph.D., M.D. | Child Psychopharmacology Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Child Psychopharmacology Institute | Fargo | North Dakota | 58103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | B. Duke and D. Staton, |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D019964 | Mood Disorders |
| D012893 | Sleep Wake Disorders |
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D014150 | Antipsychotic Agents |
| D000928 | Antidepressive Agents |
| D000697 | Central Nervous System Stimulants |
| ID | Term |
|---|---|
| D014149 | Tranquilizing Agents |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| Randomly repeated treatment course observational measurements during actigraphic measurement periods |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D011619 | Psychotropic Drugs |