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Functional and Neurochemical Brain Changes in First-episode Bipolar Mania

Information source: University of Cincinnati
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Disorder

Intervention: lithium (Drug); quetiapine (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: University of Cincinnati

Official(s) and/or principal investigator(s):
Stephen M Strakowski, MD, Principal Investigator, Affiliation: University of Cincinnati

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. 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.

Clinical Details

Official title: Functional and Neurochemical Brain Changes in First-episode Bipolar Mania Following Successful Treatment With Lithium or Quetiapine

Study design: Observational Model: Cohort, Time Perspective: Prospective

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.

Eligibility

Minimum age: 12 Years. Maximum age: 35 Years. Gender(s): Both.

Criteria:

Inclusion Criteria - First-episode manic bipolar patients (N=100; 15-20 patients/year):

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: All subjects will be excluded from participation for the following reasons. 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).

Locations and Contacts

University of Cincinnati, Cincinnati, Ohio 45267-0559, United States
Additional Information

Starting date: January 2008
Last updated: December 22, 2014

Page last updated: August 23, 2015

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