Multidimensional Measurement of Psychopharmacological Treatment Response

Completed

• Conditions: Autism Spectrum Disorders; Mood Disorders; Sleep Disorders; Attention Deficit Disorders
• Interventions: Drug: Pharmacological Intervention

• Registration Number: NCT01184235
• Lead Sponsor: Child Psychopharmacology Institute

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 Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-12
• Study First Submitted QC: 2010-08-17
• Study First Posted: 2010-08-18
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-02
• Last Update Posted: 2014-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Autism Spectrum Disorders	Pharmacological Intervention	This group will include those receiving or anticipating receiving pharmacological intervention whose primary diagnosis is Autism Spectrum Disorder
Attention Deficit Hyperactivity Disorder	Pharmacological Intervention	This group will include those receiving or anticipating receiving pharmacological intervention whose primary diagnosis is Attention Deficit Hyperactivity Disorder.
Mood Disorders	Pharmacological Intervention	This group will include those receiving or anticipating receiving pharmacological intervention whose primary diagnosis is mood disorder.

Primary Outcome Measures

Name	Time	Method
Actigraphic Measurement	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 Outcome Measures

Name	Time	Method
Operationally Defined Observations	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.

Trial Locations

Locations (1)

Child Psychopharmacology Institute; 🇺🇸 Fargo, North Dakota, United States