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Functional and Neurochemical Brain Changes in First-episode Bipolar Mania

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00609193
First Posted: February 6, 2008
Last Update Posted: December 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Stephen Strakowski, University of Cincinnati
  Purpose
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.

Condition Intervention Phase
Bipolar Disorder Drug: lithium Drug: quetiapine Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional and Neurochemical Brain Changes in First-episode Bipolar Mania Following Successful Treatment With Lithium or Quetiapine

Resource links provided by NLM:


Further study details as provided by Stephen Strakowski, University of Cincinnati:

Primary Outcome Measures:
  • 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 ]

Enrollment: 81
Study Start Date: January 2008
Study Completion Date: July 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Study subjects receiving lithium
Drug: lithium
standard clinical care
2
Study subjects receiving quetiapine
Drug: quetiapine
standard clinical care

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00609193


Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0559
Sponsors and Collaborators
University of Cincinnati
National Institutes of Health (NIH)
Investigators
Principal Investigator: Stephen M Strakowski, MD University of Cincinnati
  More Information

Responsible Party: Stephen Strakowski, Academic Director of Medicine, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00609193     History of Changes
Other Study ID Numbers: BITREC - Project I
First Submitted: January 23, 2008
First Posted: February 6, 2008
Last Update Posted: December 7, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Quetiapine Fumarate
Lithium Carbonate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Antidepressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents