Functional and Neurochemical Brain Changes in First-episode Bipolar Mania

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00609193
• Other study ID #: BITREC - Project I
• Status: Completed
• Phase: Phase 4
• First received: January 23, 2008
• Last updated: December 3, 2015
• Start date: January 2008
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 35 Years

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• lithium
standard clinical care
• quetiapine
standard clinical care

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		8 weeks	No