Multidimensional Measurement of Psychopharmacological Treatment Response

January 2, 2014 updated by: Child Psychopharmacology Institute

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

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

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Child Psychopharmacology Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Autism Spectrum Disorders
This group will include those receiving or anticipating receiving pharmacological intervention whose primary diagnosis is Autism Spectrum Disorder
Drug: Pharmacological Intervention
This study will include those anticipating or receiving any pharmacological intervention
Other Names:
  • antipsychotics
  • antidepressants
  • mood stabilizers
  • stimulants
  • NMDA antagonists
Attention Deficit Hyperactivity Disorder
This group will include those receiving or anticipating receiving pharmacological intervention whose primary diagnosis is Attention Deficit Hyperactivity Disorder.
Drug: Pharmacological Intervention
This study will include those anticipating or receiving any pharmacological intervention
Other Names:
  • antipsychotics
  • antidepressants
  • mood stabilizers
  • stimulants
  • NMDA antagonists
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.
Drug: Pharmacological Intervention
This study will include those anticipating or receiving any pharmacological intervention
Other Names:
  • antipsychotics
  • antidepressants
  • mood stabilizers
  • stimulants
  • NMDA antagonists

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Three week actigraphic measurement periods

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operationally Defined Observations
Time Frame: 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.
Randomly repeated treatment course observational measurements during actigraphic measurement periods

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Child Psychopharmacology Institute

Investigators

  • Principal Investigator: Robert D Staton, Ph.D., M.D., Child Psychopharmacology Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • B. Duke and D. Staton,

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

August 12, 2010

First Submitted That Met QC Criteria

August 17, 2010

First Posted (Estimate)

August 18, 2010

Study Record Updates

Last Update Posted (Estimate)

January 6, 2014

Last Update Submitted That Met QC Criteria

January 2, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Act3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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