Functional and Neurochemical Brain Changes in First-episode Bipolar Mania

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stephen Strakowski, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00609193
First received: January 23, 2008
Last updated: January 13, 2014
Last verified: January 2014

January 23, 2008
January 13, 2014
January 2008
July 2014   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00609193 on ClinicalTrials.gov Archive Site
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Functional and Neurochemical Brain Changes in First-episode Bipolar Mania
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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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.

Bipolar Disorder
  • Drug: lithium
    standard clinical care
  • Drug: quetiapine
    standard clinical care
  • 1
    Study subjects receiving lithium
    Intervention: Drug: lithium
  • 2
    Study subjects receiving quetiapine
    Intervention: Drug: quetiapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
July 2014
July 2014   (final data collection date for primary outcome measure)

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).
Both
12 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00609193
BITREC - Project I
No
Stephen Strakowski, University of Cincinnati
University of Cincinnati
National Institutes of Health (NIH)
Principal Investigator: Stephen M Strakowski, MD University of Cincinnati
University of Cincinnati
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP