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Multidimensional Measurement of Psychopharmacological Treatment Response

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01184235
Enrollment
44
Registered
2010-08-18
Start date
2010-08-31
Completion date
2011-08-31
Last updated
2014-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Circadian Disorders, Autism Spectrum Disorders, Mood Disorders, Executive Functioning, Pediatric Mood Disorders

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.

Interventions

This study will include those anticipating or receiving any pharmacological intervention

Sponsors

Child Psychopharmacology Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Actigraphic MeasurementThree week actigraphic measurement periodsActigraphic 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

MeasureTime frameDescription
Operationally Defined ObservationsRandomly repeated treatment course observational measurements during actigraphic measurement periodsThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026