Multidimensional Measurement of Psychopharmacological Treatment Response

Mood Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01184235
• Other study ID #: Act3
• Status: Completed
• Phase: N/A
• First received: August 12, 2010
• Last updated: January 2, 2014
• Start date: August 2010
• Est. completion date: August 2011

Study information

• Verified date: January 2014
• Source: Child Psychopharmacology Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Disorders
• Autism Spectrum Disorders
• Child Development Disorders, Pervasive
• Disease
• Mood Disorders
• Parasomnias
• Sleep Disorders

Intervention

Drug:
• Pharmacological Intervention
This study will include those anticipating or receiving any pharmacological intervention

Locations

Country	Name	City	State
United States	Child Psychopharmacology Institute	Fargo	North Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Child Psychopharmacology Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

B. Duke and D. Staton,

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No