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| Sponsored by: |
Child Psychopharmacology Institute |
|---|---|
| Information provided by: | Child Psychopharmacology Institute |
| ClinicalTrials.gov Identifier: | NCT00723580 |
Purpose
The study examines and illustrates the utility of utilizing actigraphic measurements to assess treatment response.
| Condition | Intervention |
|---|---|
|
Sleep Disorders, Circadian Rhythm Insomnia Psychomotor Agitation |
Drug: risperidone |
| Study Type: | Interventional |
| Study Design: | Health Services Research, Open Label, Uncontrolled, Single Group Assignment |
| Official Title: | Actigraphic Analysis of Treatment Response in a Six Year Old Girl With Kabuki Syndrome |
| Enrollment: | 1 |
| Study Start Date: | May 2008 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
The only arm is the actigraphic measurements that will be obtained by attaching the actigraphic watch device to the child's non-dominant wrist and will obtain measurements through baseline period and the period in which the child's pharmacological treatment is initiated.
|
Drug: risperidone
Risperidone .25 mg q.h.s. x 7 days the b.i.d.
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Actigraphic measurements will be recorded very 30 seconds and will be recorded for an 11 day baseline period, followed by a 10 day period of the initial pharmacological interventions.
Eligibility| Ages Eligible for Study: | 2 Years to 10 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, North Dakota | |
| Child Psychopharmacology Institute | |
| Fargo, North Dakota, United States, 58103 | |
| Principal Investigator: | Bill J Duke, M.A., Ph.D. | Child Psychopharmacology Institute |
More Information
| Responsible Party: | Child Psychopharmacology Institute ( Bill J. Duke, M.A., Ph.D., ABMPP ) |
| Study ID Numbers: | Act1 |
| Study First Received: | July 24, 2008 |
| Last Updated: | July 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00723580 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Kabuki Syndrome Actigraphy Treatment Response Measurement |
|
Neurotransmitter Agents Tranquilizing Agents Sleep Disorders, Circadian Rhythm Psychotropic Drugs Risperidone Central Nervous System Depressants Sleep Disorders Dyssomnias Disorders of Environmental Origin Psychomotor Agitation Chronobiology Disorders |
Antipsychotic Agents Dyskinesias Serotonin Signs and Symptoms Dopamine Mental Disorders Neurologic Manifestations Dopamine Agents Occupational Diseases Neurobehavioral Manifestations Kabuki Syndrome |
|
Neurotransmitter Agents Sleep Disorders, Circadian Rhythm Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Sleep Disorders Disorders of Environmental Origin Psychomotor Agitation Chronobiology Disorders Signs and Symptoms Serotonin Antagonists Mental Disorders Therapeutic Uses Psychomotor Disorders Occupational Diseases |
Neurobehavioral Manifestations Tranquilizing Agents Nervous System Diseases Risperidone Dyssomnias Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents Dyskinesias Pharmacologic Actions Serotonin Agents Neurologic Manifestations Dopamine Agents Central Nervous System Agents |
