Bipolar DisorderBBPPNCT01570426
Brain Imaging and Computer Games in Children With Either Bipolar Disorder, ADHD, Anxiety or Healthy Controls
An observational study of Bipolar Disorder and Attention Deficit Disorder With Hyperactivity, run by Bradley Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Attention Deficit Disorder With Hyperactivity, Attention Deficit Disorder Without Hyperactivity
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Dec 2018
- 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 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Participants will be recruited from in and around the Providence. Rhode Island area
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
Trial locations and contacts
1 site in 1 country.
PediMIND Program contact
United States1 site, 1 recruiting
- Recruiting
Bradley Hospital
East Providence, Rhode Island, 02915
Daniel P Dickstein, MD
About this study
Official title: Brain/Behavior Alterations in Pediatric Psychopathology
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.
Read the detailed description
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
- Bipolar Disorder, Attention Deficit Disorder With Hyperactivity, Attention Deficit Disorder Without Hyperactivity, Generalized Anxiety Disorder, Healthy
- 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
- Medical subject headings
- Bipolar Disorder, Attention Deficit Disorder with Hyperactivity, Generalized Anxiety Disorder, Mood Disorders, Anxiety Disorders, Mental Disorders, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral performance on computerized tasks
Measured: Day 1
MRI data (neural activation) during behavioral task
structural, functional and diffusion tensor imaging data will be collected during the second day of the study.
Measured: Day 2
Secondary outcomes (1)
Genetic material
Genetic samples (spit sample) will be examined in relation to neural activation, function, and structure as well as behavioral performance on computerized tasks.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startJul 2007
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bradley Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570426
- Sponsor's protocol ID
- 0195-07
- Other IDs
- K22MH074945
- Acronym
- BBPP
- Status last verified
- Jan 2018
- First submitted
- 27 Mar 2012
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20739018Seymour 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.
PubMed 23622855
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain/Behavior Alterations in Pediatric Psychopathology
- ClinicalTrials.gov ID
- NCT01570426
- Acronym / sponsor ID
- BBPP / 0195-07
- Conditions
- Bipolar Disorder, Attention Deficit Disorder With Hyperactivity, Attention Deficit Disorder Without Hyperactivity, Generalized Anxiety Disorder, Healthy
- Keywords
- Bipolar disorder, Mood disorders, ADHD, Attention Deficit Disorder with Hyperactivity, Attention Deficit Disorder without Hyperactivity, Anxiety disorders, Generalized anxiety disorder, Magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Bradley HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2007
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 4 Apr 2012 (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 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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Participants will be recruited from in and around the Providence. Rhode Island area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Behavioral performance on computerized tasks
Time frame: Day 1
MRI data (neural activation) during behavioral task
Time frame: Day 2
structural, functional and diffusion tensor imaging data will be collected during the second day of the study.
1 secondary outcome
Genetic material
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Results publication: PubMed 20739018Dickstein 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.
- Derived from this study: PubMed 23622855Seymour 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.
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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.
PediMIND Program contact
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 Bipolar Disorder and Attention Deficit Disorder With Hyperactivity, run by Bradley Hospital 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?
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: status not confirmed, as of the sponsor's last update on 18 Jan 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact PediMIND Program (401-432-1600, pedimind@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral performance on computerized tasks (time frame: Day 1). The study lists 2 primary outcomes in all. 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 NCT01570426, which also lists 2 linked publications.
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 18 Jan 2018.