Back to resultsNeurofunctional and Neurochemical Markers of Treatment Response in Bipolar Disorder (LAMBS/LADS)
Primary Purpose
Bipolar I Disorder
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
lithium
Lithium
Sponsored by
About this trial
This is an interventional basic science trial for Bipolar I Disorder
Eligibility Criteria
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.
Sites / Locations
- University of Cincinnati
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
1
2
Arm Description
Manic Patients
Depressed Patients
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00608075
First Posted
January 23, 2008
Last Updated
October 5, 2016
Sponsor
University of Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT00608075
Brief Title
Neurofunctional and Neurochemical Markers of Treatment Response in Bipolar Disorder
Acronym
LAMBS/LADS
Official Title
Neurofunctional and Neurochemical Markers of Treatment Response in Bipolar Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar I Disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Manic Patients
Arm Title
2
Arm Type
Other
Arm Description
Depressed Patients
Intervention Type
Drug
Intervention Name(s)
lithium
Intervention Description
600 mg - 1800 mg per day
Intervention Type
Drug
Intervention Name(s)
Lithium
Intervention Description
600 - 1800 mg
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caleb M Adler, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0559
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35585125
Citation
Lei D, Li W, Tallman MJ, Strakowski SM, DelBello MP, Rodrigo Patino L, Fleck DE, Lui S, Gong Q, Sweeney JA, Strawn JR, Nery FG, Welge JA, Rummelhoff E, Adler CM. Changes in the structural brain connectome over the course of a nonrandomized clinical trial for acute mania. Neuropsychopharmacology. 2022 Oct;47(11):1961-1968. doi: 10.1038/s41386-022-01328-y. Epub 2022 May 18.
Results Reference
derived
Learn more about this trial
Neurofunctional and Neurochemical Markers of Treatment Response in Bipolar Disorder
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