Neurofunctional and Neurochemical Markers of Treatment Response in Bipolar Disorder

Bipolar I Disorder Clinical Trial

— LAMBS/LADS  

Official title:

Neurofunctional and Neurochemical Markers of Treatment Response in Bipolar Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00608075
• Other study ID #: Adler #1
• Secondary ID: R01-0788043-01A1
• Status: Active, not recruiting
• Phase: Phase 4
• First received: January 23, 2008
• Last updated: October 5, 2016
• Start date: April 2007
• Est. completion date: July 2017

Study information

• Verified date: October 2016
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 260
• Est. completion date: July 2017
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar I Disorder
• Disease

Intervention

Drug:
• lithium
600 mg - 1800 mg per day
• Lithium
600 - 1800 mg

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The purpose of the research is to study brain structure, function and chemistry of patients with bipolar disorder who are receiving lithium.		8 weeks	No