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Completed

NCT Number: NCT00609193

Functional and Neurochemical Brain Changes in First-episode Bipolar Mania

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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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

12 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Cincinnati

Cincinnati, Ohio, 45267-0559, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • Patients meet DSM-IV criteria for type I bipolar disorder, manic or mixed.
  • Patients have an index Young Mania Rating Scale (YMRS)70 total score >20.
  • 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.
  • Patients have no more than two prior episodes of major depression.
  • 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.

  • Any chemical use disorder within 3 months.
  • Any medical or neurological disorder that could influence fMRI and MRS results.
  • A history of mental retardation or an estimated IQ total score <85.
  • An MRI scan is contraindicated in the subject.
  • The patient cannot attend follow-up visits.
  • A positive urine pregnancy test (in women).

Treatment and study plan

Lithium

Drug

standard clinical care

Quetiapine

Drug

standard clinical care

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Feb 6, 2008
Registry last updated
Dec 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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