Bipolar DisorderNCT00609193
Functional and Neurochemical Brain Changes in First-episode Bipolar Mania
An observational study of Bipolar Disorder, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this study is to use magnetic resonance imaging (MRI) to examine brain structure, function and chemistry in people with bipolar disorder who are being treated with either quetiapine or lithium. Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- lithium and quetiapine
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jul 2015
- 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 12 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: You are being asked to take part in this research study because you have been diagnosed with bipolar disorder and are currently experiencing mania. Mania is identified by periods of extreme elation or irritability, excessive energy, racing thoughts, difficulty sleeping, poor judgment and/or reckless behavior. Bipolar disorder is an illness in which people experience mania as well as mood swings into depression. To participate in this study you must be at least 12 years old and no older than 35.
Inclusion Criteria - First-episode manic bipolar patients (N=100; 15-20 patients/year):
- Patients meet DSM-IV criteria for type I bipolar disorder, manic or mixed.
- Patients have an index Young Mania Rating Scale (YMRS)70 total score >20.
- Patients have <3 months of lifetime anti-manic or anti-depressant medication exposure, including no active psychotropic medication in the one weeks prior to the index admission. Importantly, patients will NOT be taken off medications for this study; this criterion is to exclude subjects receiving active treatment at the time of admission to support the 'first-episode' criterion.
- Patients have no more than two prior episodes of major depression.
- Patients are between 12 and 35 years old; subjects < 18 yrs old have a Tanner greater than or equal to 4
Exclusion criteria: All subjects will be excluded from participation for the following reasons.
- Any chemical use disorder within 3 months.
- Any medical or neurological disorder that could influence fMRI and MRS results.
- A history of mental retardation or an estimated IQ total score <85.
- An MRI scan is contraindicated in the subject.
- The patient cannot attend follow-up visits.
- A positive urine pregnancy test (in women).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati
Cincinnati, Ohio, 45267-0559
About this study
Official title: Functional and Neurochemical Brain Changes in First-episode Bipolar Mania Following Successful Treatment With Lithium or Quetiapine
The purpose of this study is to use magnetic resonance imaging (MRI) to examine brain structure, function and chemistry in people with bipolar disorder who are being treated with either quetiapine or lithium. Both of these medicines are FDA-approved to treat mania in adults and lithium is also FDA approved in children; quetiapine is commonly used in children with mania, but is not FDA approved for this indication in this age group.
- Conditions
- Bipolar Disorder
- Being tested
- lithium, quetiapine
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lithiumDrug
standard clinical care
quetiapineDrug
standard clinical care
| Study group | Role | What they receive |
|---|---|---|
| 1 | Study subjects receiving lithium Receives: Drug: lithium | |
| 2 | Study subjects receiving quetiapine Receives: Drug: quetiapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The purpose of this study is to use magnetic resonance imaging (MRI) to examine brain structure, function and chemistry in people with bipolar disorder who are being treated with either quetiapine or lithium.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Stephen Strakowski, University of Cincinnati
- Investigators
- Stephen M Strakowski, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609193
- Sponsor's protocol ID
- BITREC - Project I
- Status last verified
- Dec 2015
- First submitted
- 23 Jan 2008
- Last updated
- 7 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lei D, Li W, Tallman MJ, Strakowski SM, DelBello MP, Rodrigo Patino L, Fleck DE, Lui S, Gong Q, Sweeney JA, Strawn JR, Nery FG, Welge JA, Rummelhoff E, Adler CM. Changes in the structural brain connectome over the course of a nonrandomized clinical trial for acute mania. Neuropsychopharmacology. 2022 Oct;47(11):1961-1968. doi: 10.1038/s41386-022-01328-y. Epub 2022 May 18.
PubMed 35585125Lippard ETC, Weber W, Welge J, Adler CM, Fleck DE, Almeida J, DelBello MP, Strakowski SM. Variation in rostral anterior cingulate functional connectivity with amygdala and caudate during first manic episode distinguish bipolar young adults who do not remit following treatment. Bipolar Disord. 2021 Aug;23(5):500-508. doi: 10.1111/bdi.13025. Epub 2020 Nov 18.
PubMed 33089593Strakowski SM, Fleck DE, Welge J, Eliassen JC, Norris M, Durling M, Komoroski RA, Chu WJ, Weber W, Dudley JA, Blom TJ, Stover A, Klein C, Strawn JR, DelBello MP, Lee JH, Adler CM. fMRI brain activation changes following treatment of a first bipolar manic episode. Bipolar Disord. 2016 Sep;18(6):490-501. doi: 10.1111/bdi.12426. Epub 2016 Sep 19.
PubMed 27647671
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Neurochemical Brain Changes in First-episode Bipolar Mania Following Successful Treatment With Lithium or Quetiapine
- ClinicalTrials.gov ID
- NCT00609193
- Acronym / sponsor ID
- BITREC - Project I
- Conditions
- Bipolar Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jan 2008
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 6 Feb 2008 (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 study is to use magnetic resonance imaging (MRI) to examine brain structure, function and chemistry in people with bipolar disorder who are being treated with either quetiapine or lithium. Both of these medicines are FDA-approved to treat mania in adults and lithium is also FDA approved in children; quetiapine is commonly used in children with mania, but is not FDA approved for this indication in this age group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: lithiumStudy subjects receiving lithium |
| 2 | – | Drug: quetiapineStudy subjects receiving quetiapine |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- You are being asked to take part in this research study because you have been diagnosed with bipolar disorder and are currently experiencing mania. Mania is identified by periods of extreme elation or irritability, excessive energy, racing thoughts, difficulty sleeping, poor judgment and/or reckless behavior. Bipolar disorder is an illness in which people experience mania as well as mood swings into depression. To participate in this study you must be at least 12 years old and no older than 35.
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 |
|---|---|---|
| lithiumstandard clinical care | Drug | 1 |
| quetiapinestandard clinical care | Drug | 2 |
Primary outcome
The purpose of this study is to use magnetic resonance imaging (MRI) to examine brain structure, function and chemistry in people with bipolar disorder who are being treated with either quetiapine or lithium.
Time frame: 8 weeks
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 7 Dec 2015.
- Derived from this study: PubMed 35585125Lei D, Li W, Tallman MJ, Strakowski SM, DelBello MP, Rodrigo Patino L, Fleck DE, Lui S, Gong Q, Sweeney JA, Strawn JR, Nery FG, Welge JA, Rummelhoff E, Adler CM. Changes in the structural brain connectome over the course of a nonrandomized clinical trial for acute mania. Neuropsychopharmacology. 2022 Oct;47(11):1961-1968. doi: 10.1038/s41386-022-01328-y. Epub 2022 May 18.
- Derived from this study: PubMed 33089593Lippard ETC, Weber W, Welge J, Adler CM, Fleck DE, Almeida J, DelBello MP, Strakowski SM. Variation in rostral anterior cingulate functional connectivity with amygdala and caudate during first manic episode distinguish bipolar young adults who do not remit following treatment. Bipolar Disord. 2021 Aug;23(5):500-508. doi: 10.1111/bdi.13025. Epub 2020 Nov 18.
- Derived from this study: PubMed 27647671Strakowski SM, Fleck DE, Welge J, Eliassen JC, Norris M, Durling M, Komoroski RA, Chu WJ, Weber W, Dudley JA, Blom TJ, Stover A, Klein C, Strawn JR, DelBello MP, Lee JH, Adler CM. fMRI brain activation changes following treatment of a first bipolar manic episode. Bipolar Disord. 2016 Sep;18(6):490-501. doi: 10.1111/bdi.12426. Epub 2016 Sep 19.
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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.
Stephen M Strakowski, MD principal investigator
University of Cincinnati
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 University of Cincinnati 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: finished, as of the sponsor's last update on 7 Dec 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?
The purpose of this study is to use magnetic resonance imaging (MRI) to examine brain structure, function and chemistry in people with bipolar disorder who are being treated with either quetiapine or lithium. (time frame: 8 weeks). 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 NCT00609193, which also lists 3 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 7 Dec 2015.