Brain Imaging and Computer Games in Children With Either Bipolar Disorder, ADHD, Anxiety or Healthy Controls

NCT ID: NCT01570426

Last Updated: 2018-01-18

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-07-31

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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This study has 2 visits (total time \~6 hours):

Visit #1 (2-3 hours), includes: (a) detailed description of study and study consent, (b) interviews about the child's mental health, mood, and behavior, and (c) a screening IQ test (word games, playing with blocks).

If a child fits our study criteria, they will play some special computer games, provide a spit sample for DNA, and parents/children will complete questionnaires.

All children fitting our study criteria, will also be invited to complete visit #2 (2 hours) consisting of a special MRI brain scan at Brown University (Providence, RI). To make sure all children feel comfortable in the MRI, they will spend time in our practice MRI (i.e., "MRI simulator") that looks and sounds just like the real MRI. During the actual MRI, children will play a computerized game in which they can win and lose points. The MRI lasts one and a half hours (at most).

Participants are compensated for their time.

Conditions

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Bipolar Disorder Attention Deficit Disorder With Hyperactivity Attention Deficit Disorder Without Hyperactivity Generalized Anxiety Disorder Healthy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Bipolar Disorder

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

No interventions assigned to this group

ADHD/ADD

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

No interventions assigned to this group

Generalized Anxiety Disorder (GAD)

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

No interventions assigned to this group

Health Controls

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Bradley Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bradley Hospital

East Providence, Rhode Island, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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PediMIND Program

Role: CONTACT

401-432-1600

PediMIND Program

Role: CONTACT

401-432-1600

References

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Dickstein DP, Gorrostieta C, Ombao H, Goldberg LD, Brazel AC, Gable CJ, Kelly C, Gee DG, Zuo XN, Castellanos FX, Milham MP. Fronto-temporal spontaneous resting state functional connectivity in pediatric bipolar disorder. Biol Psychiatry. 2010 Nov 1;68(9):839-46. doi: 10.1016/j.biopsych.2010.06.029. Epub 2010 Aug 24.

Reference Type RESULT
PMID: 20739018 (View on PubMed)

Seymour KE, Pescosolido MF, Reidy BL, Galvan T, Kim KL, Young M, Dickstein DP. Emotional face identification in youths with primary bipolar disorder or primary attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2013 May;52(5):537-546.e3. doi: 10.1016/j.jaac.2013.03.011.

Reference Type DERIVED
PMID: 23622855 (View on PubMed)

Other Identifiers

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K22MH074945

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0195-07

Identifier Type: -

Identifier Source: org_study_id

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