Bipolar Affective DisorderNCT02083978
Bipolar Research Study Using MR Imaging
An observational study of Bipolar Affective Disorder, run by Washington University Early Recognition Center at 1 site in United States.
Trial summary
In this proposal, the investigators will focus on subcortical gray and white matter structures commonly found to be abnormal in schizophrenia. Thus, the investigators will evaluate the volume and shape of the hippocampus, thalamus and basal ganglia, as well as measures of structural integrity of the corpus callosum… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Affective Disorder
- What is being tested?
- MRI scanning
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2014
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Community Sample
Who may be able to join
- between the ages of 18-30
- diagnosed with Bipolar Disorder
Who cannot join
- history of head injury
- unstable medical condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Neuromorphometry of Psychosis in Bipolar Disorder
In this proposal, the investigators will focus on subcortical gray and white matter structures commonly found to be abnormal in schizophrenia. Thus, the investigators will evaluate the volume and shape of the hippocampus, thalamus and basal ganglia, as well as measures of structural integrity of the corpus callosum and its various subregions.
Read the detailed description
There are relatively few studies evaluating brain structure in bipolar disorder (BD), the results of which have been largely inconsistent, both in terms of what abnormalities are present in BD and whether they show any similar abnormalities to those found in schizophrenia. One possibility that might explain the varying degree of reported similarity in structural findings in schizophrenia and BD is that there might be effects of BPD diagnostic subtype associated with brain structure. One viewpoint that contrasts schizophrenia and BD considers psychotic (PBD) to differ from non-psychotic (NPBD) subtypes in terms of shared pathophysiology with schizophrenia. PBD has been reported as being of special interest, as it shares symptomatic overlap with schizophrenia, "runs in families", shares a chromosomal linkage to the 13q13-32 and 22q12 with schizophrenia, shows similar increases in dopamine receptor Bmax induced by [c-11] N-methylspiperone positron emission tomography and similar working memory impairments as in schizophrenia. If PBP and NPBP are associated with different forms of brain pathology, then merging the two entities into a single "bipolar group" might obscure relevant anatomic differences if these occur primarily in only one group. In this proposal, the investigators will focus on subcortical gray and white matter structures commonly found to be abnormal in schizophrenia. Thus, the investigators will evaluate the volume and shape of the hippocampus, thalamus and basal ganglia, as well as measures of structural integrity of the corpus callosum and its various subregions.
- Conditions
- Bipolar Affective Disorder
- Being tested
- MRI scanning
- Keywords
- Bipolar Disorder, Magnetic Resonance Imaging (MRI) scanning
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scanningOther
| Study group | Role | What they receive |
|---|---|---|
| Bipolar Diagnosis | Individuals identified as having a Bipolar Diagnosis with a manic episode Receives: Other: MRI scanning | |
| Control | Individuals identified as not having a major psychiatric diagnosis Receives: Other: MRI scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
subcortical grey and white matter structures
Evaluation of the volume and shape of the hippocampus, thalamus and basal ganglia, as well as measures of structural integrity of the corpus callosum and its various subregions.
Measured: within one month of study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startJan 2010
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Affective 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University Early Recognition Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Mamah, M.D, MPE, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083978
- Sponsor's protocol ID
- 201105453
- Status last verified
- Jun 2015
- First submitted
- 7 Mar 2014
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromorphometry of Psychosis in Bipolar Disorder
- ClinicalTrials.gov ID
- NCT02083978
- Acronym / sponsor ID
- 201105453
- Conditions
- Bipolar Affective Disorder
- Keywords
- Bipolar Disorder, Magnetic Resonance Imaging (MRI) scanning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Washington University Early Recognition CenterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Mar 2014 (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.
In this proposal, the investigators will focus on subcortical gray and white matter structures commonly found to be abnormal in schizophrenia. Thus, the investigators will evaluate the volume and shape of the hippocampus, thalamus and basal ganglia, as well as measures of structural integrity of the corpus callosum and its various subregions.
Detailed description
There are relatively few studies evaluating brain structure in bipolar disorder (BD), the results of which have been largely inconsistent, both in terms of what abnormalities are present in BD and whether they show any similar abnormalities to those found in schizophrenia. One possibility that might explain the varying degree of reported similarity in structural findings in schizophrenia and BD is that there might be effects of BPD diagnostic subtype associated with brain structure. One viewpoint that contrasts schizophrenia and BD considers psychotic (PBD) to differ from non-psychotic (NPBD) subtypes in terms of shared pathophysiology with schizophrenia. PBD has been reported as being of special interest, as it shares symptomatic overlap with schizophrenia, "runs in families", shares a chromosomal linkage to the 13q13-32 and 22q12 with schizophrenia, shows similar increases in dopamine receptor Bmax induced by [c-11] N-methylspiperone positron emission tomography and similar working memory impairments as in schizophrenia. If PBP and NPBP are associated with different forms of brain pathology, then merging the two entities into a single "bipolar group" might obscure relevant anatomic differences if these occur primarily in only one group. In this proposal, the investigators will focus on subcortical gray and white matter structures commonly found to be abnormal in schizophrenia. Thus, the investigators will evaluate the volume and shape of the hippocampus, thalamus and basal ganglia, as well as measures of structural integrity of the corpus callosum and its various subregions.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipolar Diagnosis | – | Other: MRI scanningIndividuals identified as having a Bipolar Diagnosis with a manic episode |
| Control | – | Other: MRI scanningIndividuals identified as not having a major psychiatric diagnosis |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community Sample
Key inclusion criteria (2 listed)
- between the ages of 18-30
- diagnosed with Bipolar Disorder
Key exclusion criteria (2 listed)
- history of head injury
- unstable medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI scanning | Other | Bipolar Diagnosis, Control |
Primary outcome
subcortical grey and white matter structures
Time frame: within one month of study enrollment
Evaluation of the volume and shape of the hippocampus, thalamus and basal ganglia, as well as measures of structural integrity of the corpus callosum and its various subregions.
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 3 Jun 2015.
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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.
Daniel Mamah, M.D, MPE principal investigator
Washington University School of Medicine
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 Affective Disorder, run by Washington University Early Recognition Center 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 2 inclusion and 2 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 3 Jun 2015. 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?
subcortical grey and white matter structures (time frame: within one month of study enrollment). 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 3 Jun 2015.