Functional and Neurochemical Brain Changes in First-episode Bipolar Mania

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stephen Strakowski, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00609193
First received: January 23, 2008
Last updated: January 13, 2014
Last verified: January 2014
  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 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 ]

Estimated Enrollment: 120
Study Start Date: January 2008
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (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

Ages Eligible for Study:   12 Years to 35 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

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

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

No publications provided

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
Study First Received: January 23, 2008
Last Updated: January 13, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Lithium
Quetiapine
Antimanic Agents
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 30, 2014