Actigraphic, Observational, Psychometric and Biological Measurement of Psychopharmacological Treatment Response
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Actigraphic Measurement
Study Overview
Brief Summary
The study examines actigraphic, observational, psychometric and associated repeated measurements obtained prior to and during psychopharmacological treatment.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 6 Months to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Autism Spectrum Disorders
This group will include those receiving or anticipating receiving pharmacological intervention whose primary diagnosis is Autism Spectrum Disorder
Intervention: Pharmacological Intervention (Drug)
Attention Deficit Hyperactivity Disorder
This group will include those receiving or anticipating receiving pharmacological intervention whose primary diagnosis is Attention Deficit Hyperactivity Disorder.
Intervention: Pharmacological Intervention (Drug)
Mood Disorders
This group will include those receiving or anticipating receiving pharmacological intervention whose primary diagnosis is mood disorder.
Intervention: Pharmacological Intervention (Drug)
Outcomes
Primary Outcomes
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
- Operationally Defined Observations(Randomly repeated treatment course observational measurements during actigraphic measurement periods)