Bipolar DisorderNCT00391235
White Matter in Pediatric Bipolar Disorder: A DTI Study
An observational study of Bipolar Disorder, run by Cambridge Health Alliance at 1 site in United States.
Trial summary
Fourteen subjects with bipolar disorder and 14 matching healthy controls, aged 6-13, will receive a magnetic resonance imaging (MRI) scan on a 3 Tesla scanner. They will also have a clinical interview, including the KSADS-PL. All subjects must be right-handed. Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Oct 2008
- 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 6 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Bipolar Disorder
Who may be able to join
- Age 6 to 13
- Male or female
- Right-handed
Who cannot join
- IQ less than 70
- Learning disabilities
- History of autism, schizophrenia, anorexia or bulimia nervosa
- Substance abuse
- Claustrophobia
- Metal in body
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
United States1 site
Cambridge Health Alliance
Medford, Massachusetts, 02155
About this study
Official title: White Matter Connectivity in Pediatric Bipolar Disorder: A Diffusion Tensor Imaging Study
Fourteen subjects with bipolar disorder and 14 matching healthy controls, aged 6-13, will receive a magnetic resonance imaging (MRI) scan on a 3 Tesla scanner. They will also have a clinical interview, including the KSADS-PL. All subjects must be right-handed.
Read the detailed description
We propose to investigate the connectivity of white matter tracts using diffusion tensor imaging (DTI) in children with very early onset bipolar disorder (BPD). We hypothesize that the connectivity between the prefrontal cortex and the temporal lobe and parietal lobe and limbic structures will be abnormal, indicating white matter and gray matter deficits in early onset BPD. We also hypothesize that the superior lateral fasciculus cingulum bundle and the inferior lateral fasciculus will have decreased fractional anisotropy in very early onset BPD relative to healthy controls.
- Conditions
- Bipolar Disorder
- Keywords
- bipolar disorder, magnetic resonance imaging, white matter, diffusion tensor imaging, children, adolescents
- Medical subject headings
- Bipolar Disorder
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 |
|---|---|---|
| BPD | Children with bipolar disorder | |
| HC | Healthy comparison children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional anisotropy in brain white matter
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2006 (estimated)
- Study startSep 2005
- Primary completionSep 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Child Adolescent Psychiatry., Eli Lilly and Company
- Investigators
- Jean A Frazier, MD, Principal investigator, Cambridge Health Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391235
- Sponsor's protocol ID
- CHA-IRB-0132/09/05
- Status last verified
- Dec 2010
- First submitted
- 19 Oct 2006
- Last updated
- 6 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- White Matter Connectivity in Pediatric Bipolar Disorder: A Diffusion Tensor Imaging Study
- ClinicalTrials.gov ID
- NCT00391235
- Acronym / sponsor ID
- CHA-IRB-0132/09/05
- Conditions
- Bipolar Disorder
- Keywords
- bipolar disorder, magnetic resonance imaging, white matter, diffusion tensor imaging, children, adolescents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cambridge Health AllianceUniversity, hospital or other
- Collaborators
- American Academy of Child Adolescent Psychiatry., Eli Lilly and Company
- Study start
- Sep 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 23 Oct 2006 (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.
Fourteen subjects with bipolar disorder and 14 matching healthy controls, aged 6-13, will receive a magnetic resonance imaging (MRI) scan on a 3 Tesla scanner. They will also have a clinical interview, including the KSADS-PL. All subjects must be right-handed.
Detailed description
We propose to investigate the connectivity of white matter tracts using diffusion tensor imaging (DTI) in children with very early onset bipolar disorder (BPD). We hypothesize that the connectivity between the prefrontal cortex and the temporal lobe and parietal lobe and limbic structures will be abnormal, indicating white matter and gray matter deficits in early onset BPD. We also hypothesize that the superior lateral fasciculus cingulum bundle and the inferior lateral fasciculus will have decreased fractional anisotropy in very early onset BPD relative to healthy controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPD | – | –Children with bipolar disorder |
| HC | – | –Healthy comparison children |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Bipolar Disorder
Key inclusion criteria (3 listed)
- Age 6 to 13
- Male or female
- Right-handed
Key exclusion criteria (7 listed)
- IQ less than 70
- Learning disabilities
- History of autism, schizophrenia, anorexia or bulimia nervosa
- Substance abuse
- Claustrophobia
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
Fractional anisotropy in brain white matter
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2010.
- Description of this research program at Cambridge Health AllianceLink provided by the sponsor.
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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.
Jean A Frazier, MD principal investigator
Cambridge Health Alliance
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, run by Cambridge Health Alliance 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?
The sponsor lists 3 inclusion and 7 exclusion criteria. 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: finished, as of the sponsor's last update on 6 Dec 2010. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional anisotropy in brain white matter (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2010; AzTrials last refreshed its copy on 6 Nov 2026.