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Functional and Neurochemical Brain Changes in First-episode Bipolar Mania

NCT ID: NCT00609193

Last Updated: 2015-12-07

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

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2015-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bipolar Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Study subjects receiving lithium

lithium

Intervention Type DRUG

standard clinical care

2

Study subjects receiving quetiapine

quetiapine

Intervention Type DRUG

standard clinical care

Interventions

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lithium

standard clinical care

Intervention Type DRUG

quetiapine

standard clinical care

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients meet DSM-IV criteria for type I bipolar disorder, manic or mixed.
2. Patients have an index Young Mania Rating Scale (YMRS)70 total score \>20.
3. 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.
4. Patients have no more than two prior episodes of major depression.
5. Patients are between 12 and 35 years old; subjects \< 18 yrs old have a Tanner greater than or equal to 4

Exclusion Criteria

1. Any chemical use disorder within 3 months.
2. Any medical or neurological disorder that could influence fMRI and MRS results.
3. A history of mental retardation or an estimated IQ total score \<85.
4. An MRI scan is contraindicated in the subject.
5. The patient cannot attend follow-up visits.
6. A positive urine pregnancy test (in women).
Minimum Eligible Age

12 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Stephen Strakowski

Academic Director of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephen M Strakowski, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

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University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35585125 (View on PubMed)

Lippard 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.

Reference Type DERIVED
PMID: 33089593 (View on PubMed)

Strakowski 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.

Reference Type DERIVED
PMID: 27647671 (View on PubMed)

Other Identifiers

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BITREC - Project I

Identifier Type: -

Identifier Source: org_study_id