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

This study is currently recruiting participants.
Verified by University of Cincinnati, July 2008

Sponsored by: University of Cincinnati
Information provided by: University of Cincinnati
ClinicalTrials.gov Identifier: NCT00609193
  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
Drug: lithium
Drug: quetiapine
Phase IV

MedlinePlus related topics:   Bipolar Disorder    MRI Scans   

Drug Information available for:   Quetiapine    Quetiapine fumarate    Lithium carbonate    Lithium citrate   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective

Further study details as provided by 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   120
Study Start Date:   January 2008
Estimated Study Completion Date:   July 2013
Estimated Primary Completion Date:   July 2012 (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
3
Healthy controls

  Eligibility
Ages Eligible for Study:   16 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 16 years old and no older than 35.


Criteria

Inclusion Criteria - First-episode manic bipolar patients (N=80; 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 no prior psychiatric hospitalizations and <3 months of lifetime psychotropic medication exposure, including no active psychotropic medication in the two 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 16 and 35 years old.

Inclusion Criteria - Healthy subjects (N=40; 8-10 subjects/year):

  1. Healthy subjects are 16 to 35 years old.
  2. Healthy subjects have no history of any Axis I psychiatric disorder.
  3. Healthy subjects have no first-degree relatives with affective or psychotic disorders.

Exclusion criteria: All subjects will be excluded from participation for the following reasons.

  1. Any history of alcohol or drug dependence, and any alcohol or drug 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609193

Contacts
Contact: Jonathon Schroer, BA, BPh     513-558-3991     jonathon.schroer@uc.edu    

Locations
United States, Ohio
University of Cincinnati     Recruiting
      Cincinnati, Ohio, United States, 45267-0559

Sponsors and Collaborators
University of Cincinnati

Investigators
Principal Investigator:     Stephen M Strakowski, MD     University of Cincinnati    
  More Information


Responsible Party:   University of Cincinnati ( Stephen M. Strakowski, MD )
Study ID Numbers:   BITREC - Project I
First Received:   January 23, 2008
Last Updated:   July 21, 2008
ClinicalTrials.gov Identifier:   NCT00609193
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Quetiapine
Lithium Carbonate
Lithium

Additional relevant MeSH terms:
Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antimanic Agents
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 03, 2008




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