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
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