Neurofunctional and Neurochemical Markers of Treatment Response in Bipolar Mania
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Caleb M. Adler, University of Cincinnati
First received: January 23, 2008
Last updated: December 9, 2013
Last verified: December 2013
The purpose of the research is to study brain structure, function and chemistry of patients with bipolar disorder who are receiving lithium, an FDA-approved treatment for bipolar mania, in order to better understand who benefits from treatment and why they respond to medications. Studying this may help improve treatment and outcome in patients with bipolar disorder.
Bipolar I Disorder
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
||Neurofunctional and Neurochemical Markers of Treatment Response in Bipolar Disorder
Primary Outcome Measures:
- The purpose of the research is to study brain structure, function and chemistry of patients with bipolar disorder who are receiving lithium. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2014 (Final data collection date for primary outcome measure)
600 mg - 1800 mg per day
600 - 1800 mg
|Ages Eligible for Study:
||15 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Inclusion Criteria- bipolar patients (Manic=, depressed=60; 30 patients/year):
- The patient meets DSM-IV criteria for type I bipolar disorder, manic or mixed, or depressed.
- The patient has an index Young Mania Rating Scale (YMRS)total score >15 or Montgomery Asberg Rating Scale (MADRS) total score >20.
- The patient is between 15 and 55 years old.
Inclusion Criteria- Healthy subjects (N=40):
- Healthy subjects will be between the ages of 15 and 55 years.
- Healthy subjects will have no history of any Axis I psychiatric disorder.
- Healthy subjects will have no first-degree relatives with affective or psychotic disorders.
Exclusion criteria: All subjects will be excluded from participation for the following reasons.
- 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 for any reason, including psychological impediments to being inside the MR scanner.
- The patient cannot attend follow-up visits.
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: NCT00608075
|University of Cincinnati
|Cincinnati, Ohio, United States, 45267-0559 |
University of Cincinnati
||Caleb M Adler, MD
||University of Cincinnati
No publications provided
||Caleb M. Adler, Associate Professor, University of Cincinnati
History of Changes
|Other Study ID Numbers:
||Adler #1, R01-0788043-01A1
|Study First Received:
||January 23, 2008
||December 9, 2013
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 14, 2014
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action