Functional and Neurochemical Brain Changes in First-episode Bipolar Mania

December 3, 2015 updated by: Stephen Strakowski, University of Cincinnati

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0559
        • University of Cincinnati

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Study subjects receiving lithium
Drug: lithium
standard clinical care
2
Study subjects receiving quetiapine
Drug: quetiapine
standard clinical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Stephen M Strakowski, MD, University of Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

January 23, 2008

First Submitted That Met QC Criteria

January 23, 2008

First Posted (Estimate)

February 6, 2008

Study Record Updates

Last Update Posted (Estimate)

December 7, 2015

Last Update Submitted That Met QC Criteria

December 3, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BITREC - Project I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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