Overview

Neurofunctional and Neurochemical Markers of Treatment Response in Bipolar Disorder

Status:
Unknown status
Trial end date:
2017-07-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Cincinnati
Treatments:
Lithium Carbonate
Criteria
Inclusion Criteria- bipolar patients (Manic=, depressed=60; 30 patients/year):

1. The patient meets DSM-IV criteria for type I bipolar disorder, manic or mixed, or
depressed.

2. The patient has an index Young Mania Rating Scale (YMRS)total score >15 or Montgomery
Asberg Rating Scale (MADRS) total score >20.

3. The patient is between 15 and 55 years old.

Inclusion Criteria- Healthy subjects (N=40):

1. Healthy subjects will be between the ages of 15 and 55 years.

2. Healthy subjects will have no history of any Axis I psychiatric disorder.

3. 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.

1. Any medical or neurological disorder that could influence fMRI and MRS results.

2. A history of mental retardation or an estimated IQ total score <85.

3. An MRI scan is contraindicated in the subject for any reason, including psychological
impediments to being inside the MR scanner.

4. The patient cannot attend follow-up visits.