Autism Spectrum DisordersNCT01184235
Multidimensional Measurement of Psychopharmacological Treatment Response
An observational study of Autism Spectrum Disorders and Mood Disorders, run by Child Psychopharmacology Institute at 1 site in United States.
Trial summary
The study examines actigraphic, observational, psychometric and associated repeated measurements obtained prior to and during psychopharmacological treatment. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorders, Mood Disorders, Sleep Disorders
- What is being tested?
- Pharmacological Intervention
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Inability to wear an actigraphy watch
Trial locations and contacts
1 site in 1 country.
United States1 site
Child Psychopharmacology Institute
Fargo, North Dakota, 58103
About this study
Official title: 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.
Read the 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.
- Being tested
- Pharmacological Intervention
- Keywords
- Circadian Disorders, Autism Spectrum Disorders, Mood Disorders, Executive Functioning, Pediatric Mood Disorders
- Medical subject headings
- Autism Spectrum Disorder, Mood Disorders, Sleep Wake Disorders, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacological InterventionDrug
Also called antipsychotics, antidepressants, mood stabilizers, stimulants
This study will include those anticipating or receiving any pharmacological intervention
| Study group | Role | What they receive |
|---|---|---|
| Autism Spectrum Disorders | This group will include those receiving or anticipating receiving pharmacological intervention whose primary diagnosis is Autism Spectrum Disorder Receives: 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. Receives: 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. Receives: Drug: Pharmacological Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three week actigraphic measurement periods
Secondary outcomes (1)
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.
Measured: Randomly repeated treatment course observational measurements during actigraphic measurement periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Child Psychopharmacology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bill J Duke, M.A., Ph.D., Principal investigator, Child Psychopharmacology InstituteRobert D Staton, Ph.D., M.D., Principal investigator, Child Psychopharmacology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184235
- Sponsor's protocol ID
- Act3
- Status last verified
- Jan 2014
- First submitted
- 12 Aug 2010
- Last updated
- 6 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
B. Duke and D. Staton,
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Actigraphic, Observational, Psychometric and Biological Measurement of Psychopharmacological Treatment Response
- ClinicalTrials.gov ID
- NCT01184235
- Acronym / sponsor ID
- Act3
- Keywords
- Circadian Disorders, Autism Spectrum Disorders, Mood Disorders, Executive Functioning, Pediatric Mood Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Child Psychopharmacology InstituteUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 18 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Autism Spectrum Disorders | – | Drug: Pharmacological InterventionThis group will include those receiving or anticipating receiving pharmacological intervention whose primary diagnosis is Autism Spectrum Disorder |
| Attention Deficit Hyperactivity Disorder | – | Drug: Pharmacological InterventionThis group will include those receiving or anticipating receiving pharmacological intervention whose primary diagnosis is Attention Deficit Hyperactivity Disorder. |
| 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 | – | Drug: Pharmacological InterventionThis group will include those receiving or anticipating receiving pharmacological intervention whose primary diagnosis is mood disorder. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Diagnosis of:
- Autism Spectrum Disorder
- Mood Disorder
- Attention Deficit Hyperactivity Disorder
- Unaffected First Degree Relative of Study Subject
Key exclusion criteria (1 listed)
- Inability to wear an actigraphy watch
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacological InterventionAlso: antipsychotics, antidepressants, mood stabilizers, stimulantsThis study will include those anticipating or receiving any pharmacological intervention | Drug | Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorders, Mood Disorders |
Primary outcome
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.
1 secondary outcome
Operationally Defined Observations
Time frame: Randomly repeated treatment course observational measurements during actigraphic measurement periods
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2014.
- Results publicationB. Duke and D. Staton,
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bill J Duke, M.A., Ph.D. principal investigator
Child Psychopharmacology Institute
Robert D Staton, Ph.D., M.D. principal investigator
Child Psychopharmacology Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorders and Mood Disorders, run by Child Psychopharmacology Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actigraphic Measurement (time frame: Three week actigraphic measurement periods). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01184235, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2014.