Multidimensional Measurement of Psychopharmacological Treatment Response

NCT01184235 | Completed

• 1 other identifier: Act3
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Autism Spectrum Disorders; Mood Disorders; Sleep Disorders; Attention Deficit Disorders

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Operationally Defined Observations

  Randomly repeated treatment course observational measurements during actigraphic measurement periods

Study Arms (4)

Autism Spectrum Disorders

This group will include those receiving or anticipating receiving pharmacological intervention whose primary diagnosis is Autism Spectrum Disorder

Drug: Pharmacological Intervention

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

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

Interventions

Pharmacological Intervention DRUG

This study will include those anticipating or receiving any pharmacological intervention

Also known as: antipsychotics, antidepressants, mood stabilizers, stimulants, NMDA antagonists

Attention Deficit Hyperactivity Disorder; Autism Spectrum Disorders; Mood Disorders

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Inability to wear an actigraphy watch

Sponsors & Collaborators

• Child Psychopharmacology Institute: lead

Study Sites (1)

Child Psychopharmacology Institute

Fargo, North Dakota, 58103, United States

Location

Related Publications (1)

• B. Duke and D. Staton,

  RESULT

MeSH Terms

Conditions

Autism Spectrum Disorder; Mood Disorders; Sleep Wake Disorders; Attention Deficit Disorder with Hyperactivity

Interventions

Antipsychotic Agents; Antidepressive Agents; Central Nervous System Stimulants

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Attention Deficit and Disruptive Behavior Disorders

Intervention Hierarchy (Ancestors)

Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs

Study Officials

• Bill J Duke, M.A., Ph.D.

  Child Psychopharmacology Institute

  PRINCIPAL INVESTIGATOR

• Robert D Staton, Ph.D., M.D.

  Child Psychopharmacology Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2010
• First Posted: August 18, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: January 6, 2014

Record last verified: 2014-01

Locations

US (1)