Functional and Neurochemical Brain Changes in First-episode Bipolar Mania
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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 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 |
- 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 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
|
Eligibility| Ages Eligible for Study: | 12 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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).
Contacts and Locations| Contact: DeAnna Owens, BA | 513-558-1193 | owensd2@uc.edu |
| United States, Ohio | |
| University of Cincinnati | Recruiting |
| Cincinnati, Ohio, United States, 45267-0559 | |
| Principal Investigator: | Stephen M Strakowski, MD | University of Cincinnati |
More Information
No publications provided
| Responsible Party: | Stephen M. Strakowski, MD, 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: | March 23, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Lithium Quetiapine Lithium Carbonate Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Antimanic Agents Antidepressive Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013