LAMBS/LADS: Neurofunctional and Neurochemical Markers of Treatment Response in Bipolar Disorder

• Sponsor: University of Cincinnati (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00608075
• Collaborator: (none)
• Enrollment: 260
• Location: 1
• Arms: 2
• Duration (Months): 123
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar I Disorder	Drug: lithium; Drug: Lithium	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 260 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Neurofunctional and Neurochemical Markers of Treatment Response in Bipolar Disorder
• Study Start Date: Apr 1, 2007
• Actual Primary Completion Date: Jul 1, 2015
• Anticipated Study Completion Date: Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: 1 Manic Patients	Drug: lithium; 600 mg - 1800 mg per day
Other: 2 Depressed Patients	Drug: Lithium; 600 - 1800 mg

Outcome Measures

Primary Outcome Measures

1. The purpose of the research is to study brain structure, function and chemistry of patients with bipolar disorder who are receiving lithium. [8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Cincinnati	Cincinnati	Ohio	United States	45267-0559

Sponsors and Collaborators

• University of Cincinnati

Investigators

• Principal Investigator: Caleb M Adler, MD, University of Cincinnati

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Caleb M. Adler, Associate Professor, University of Cincinnati
• ClinicalTrials.gov Identifier: NCT00608075
• Other Study ID Numbers: Adler #1; R01-0788043-01A1
• First Posted: Feb 6, 2008
• Last Update Posted: Oct 6, 2016
• Last Verified: Oct 1, 2016

• Additional relevant MeSH terms: Bipolar Disorder; Lithium Carbonate

Study Results

No Results Posted as of Oct 6, 2016