Recruiting

Observational Study

Sponsor:

Bradley Hospital

Code:

NCT01570426

Conditions

Bipolar Disorder

Attention Deficit Disorder With Hyperactivity

Attention Deficit Disorder Without Hyperactivity

Generalized Anxiety Disorder

Healthy

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Accepted

Study Details

Brief summary:

The purpose of this research is to learn more about how children with mental health problems, including bipolar disorder (BD), attention deficit hyperactivity disorder (ADHD), and generalized anxiety disorder (GAD), differ from children without these problems. The investigators want to understand how these 4 groups of children differ in brain activity, function, and structure.

Conditions

Bipolar Disorder

Attention Deficit Disorder With Hyperactivity

Attention Deficit Disorder Without Hyperactivity

Generalized Anxiety Disorder

Healthy

Study ID

NCT01570426

Start date

Jul, 2007

Status verified date

Jan, 2018

Completion date

Dec, 2018

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Accepted

General Inclusion Criteria:

  • English- speaking,children \& adolescents between the ages of 7- 17
  • consenting parent/guardian

General Exclusion Criteria:

  • estimated IQ less than 70
  • substance/alcohol use or dependence within the last 2 months
  • Autism Spectrum Disorders or primary psychosis
  • medical/neurological conditions that mimic the psychiatric disorders of interest
  • implanted metal (NO BRACES or COCHLEAR IMPLANT)

For inclusion in the Bipolar group, participants:

  • have to meet Diagnostic and Statistical Manual, 4th Edition Text Revision (DSM-IV-TR) criteria for BD Type I, including at least one lifetime episode of mania

For inclusion in the ADHD/ADD group, participants:

  • meet DSM-IV-TR criteria for any subtype of ADHD or ADD
  • can not currently meet diagnostic criteria for bipolar, depressive or anxiety disorders

For inclusion in the Generalized Anxiety Group (GAD), participants:

  • have to meet DSM-IV-TR criteria for GAD
  • can not currently meet diagnostic criteria for Obsessive Compulsive Disorder (OCD) or Post-Traumatic Stress Disorder (PTSD)

For inclusion in the Healthy Control group, participants:

  • can not have a past/current history of psychiatric or substance use disorders
  • can not have a first-degree relative (parents, brothers/sisters) with a history of psychiatric illness

Study Design

Enrollment

240 participants

Anticipated

Interventions and Outcome Measures

Arms

Bipolar Disorder

Children, 7- 17 years-old, who meet diagnostic criteria for bipolar disorder, Type 1

ADHD/ADD

Children, 7-17 years-old, who meet diagnostic criteria for attention deficit/hyperactivity disorder (ADHD) OR attention deficit disorder (without hyperactivity)

Generalized Anxiety Disorder (GAD)

Children, 7-17 years-old, who meet diagnostic criteria for Generalized Anxiety Disorder (GAD)

Health Controls

Children, ages 7-17 years-old, without a history of psychiatric diagnosis

Primary outcome measure

  • Behavioral performance on computerized tasks [ Time Frame: Day 1 ]
  • MRI data (neural activation) during behavioral task [ Time Frame: Day 2 ]

Central Contacts and Locations

Central contacts

PediMIND Program

401-432-1600pedimind@gmail.com

PediMIND Program

401-432-1600

Locations

Bradley Hospital

Recruiting

East Providence, Rhode Island, United States, 02915

Principal Investigator:

Daniel P Dickstein, MD

More Information

Sponsor

Bradley Hospital

Last update posted

Jan 18, 2018

Last verified

Jan, 2018

Keywords

  • Bipolar disorder
  • Mood disorders
  • ADHD
  • Attention Deficit Disorder with Hyperactivity
  • Attention Deficit Disorder without Hyperactivity
  • Anxiety disorders
  • Generalized anxiety disorder
  • Magnetic resonance imaging
  • Mental disorders
  • Mental disorders diagnosed in childhood
  • affective neuroscience
  • emotion
  • MRI
  • fMRI
  • neurocognitive tasks
  • imaging
  • Healthy controls
  • typical development

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bradley Hospital on 2018-01-18.