Brain Activity Flow Patterns Analysis Using Evoked Response Potentials in Youth With ADHD, Bipolar Disorder, or Autism Spectrum Disorders: A Preliminary Study
NCT ID: NCT01506232
Last Updated: 2024-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
1 participants
OBSERVATIONAL
2011-03-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ADHD
Youth diagnosed with ADHD.
No interventions assigned to this group
ASD
Youth diagnosed with an Autism Spectrum Disorder (ASD).
No interventions assigned to this group
BPD
Youth diagnosed with Bipolar Disorder.
No interventions assigned to this group
Healthy Controls
Youth not diagnosed with any psychiatric/psychological disorder.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Right handedness.
* Fulfills DSM-IV-TR diagnostic criteria for ADHD, bipolar disorder (BPD I, II, or NOS), or ASD (autistic disorder, Asperger's disorder, or PDD-NOS) as established by clinical diagnostic interview and supported by K-SADS-E module for respective diagnoses.
* Subjects and their legal representative must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
* Subjects and their legal representative must be considered reliable.
* Each subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document and the subject must sign an informed assent document.
Exclusion Criteria
* I.Q. \< 85
* History of active seizure disorder (as suggested by EEG suggestive of seizure activity and/or history of seizure in last 1 month)
* Pregnant or nursing females.
* Subjects with a medical condition that will either jeopardize subject safety or affect the scientific merit of the study, including:
* Organic brain disorders
* Uncorrected hypothyroidism or hyperthyroidism
* Renal or hepatic impairment.
* Clinically unstable psychiatric conditions or judged to be at serious suicidal risk
* Current diagnosis of schizophrenia
* History of substance use (except nicotine or caffeine) within past 3 months or urine drug screen positive for substances of abuse
* Significant sensory deficits such as deafness or blindness.
6 Years
17 Years
ALL
Yes
Sponsors
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ElMindA Ltd
INDUSTRY
Massachusetts General Hospital
OTHER
Responsible Party
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Gagan Joshi
Scientific Director, Pervasive Developmental Disorders Program, Clinical and Research Programs in Pediatric Psychopharmacology
Principal Investigators
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Gagan Joshi, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Cambridge, Massachusetts, United States
Countries
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Other Identifiers
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2010P000547
Identifier Type: -
Identifier Source: org_study_id
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