Functional and Neurochemical Brain Changes in First-episode Bipolar Mania
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Stephen Strakowski, University of Cincinnati
First received: January 23, 2008
Last updated: January 13, 2014
Last verified: January 2014
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Functional and Neurochemical Brain Changes in First-episode Bipolar Mania Following Successful Treatment With Lithium or Quetiapine
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2014 (Final data collection date for primary outcome measure)
Study subjects receiving lithium
standard clinical care
Study subjects receiving quetiapine
standard clinical care
|Ages Eligible for Study:
||12 Years to 35 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
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).
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
|University of Cincinnati
|Cincinnati, Ohio, United States, 45267-0559 |
University of Cincinnati
||Stephen M Strakowski, MD
||University of Cincinnati
No publications provided
||Stephen Strakowski, Academic Director of Medicine, University of Cincinnati
History of Changes
|Other Study ID Numbers:
||BITREC - Project I
|Study First Received:
||January 23, 2008
||January 13, 2014
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 14, 2014
Affective Disorders, Psychotic
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action