Neurofunctional and Neurochemical Markers of Treatment Response in Bipolar Disorder
LAMBS/LADS
2 other identifiers
interventional
260
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2007
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 23, 2008
CompletedFirst Posted
Study publicly available on registry
February 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedOctober 6, 2016
October 1, 2016
8.3 years
January 23, 2008
October 5, 2016
Conditions
Outcome Measures
Primary Outcomes (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
Study Arms (2)
1
OTHERManic Patients
2
OTHERDepressed Patients
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Cincinnati
Cincinnati, Ohio, 45267-0559, United States
Related Publications (1)
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.
PMID: 35585125DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Caleb M Adler, MD
University of Cincinnati
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 23, 2008
First Posted
February 6, 2008
Study Start
April 1, 2007
Primary Completion
July 1, 2015
Study Completion
July 1, 2017
Last Updated
October 6, 2016
Record last verified: 2016-10