Ignite Creation Date:
2024-05-05 @ 10:10 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01042496
Status:
COMPLETED
Last Update Posted:
2016-02-08
First Post:
2010-01-04
Brief Title:
Bipolar Depression Before and After Lamotrigine Treatment
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
1H-MR Spectroscopy of Bipolar Depression Before and After Lamotrigine Treatment
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
1HMRS-BP
Brief Summary:
This study compared glutamate and other neurometabolites measured by proton magnetic resonance spectroscopy 1H-MRS in bipolar I and II patients currently depressed with age-matched healthy controls The study will also compare 1H-MRS of bipolar I and II patients before and after taking a 12-week course of lamotrigine
The goal of this study was to better understand the neurobiology of bipolar depression and how lamotrigine may therapeutically impact brain function and mood response
The hypothesis was that in comparison to non-remission participants bipolar participants who achieve remission defined as a Montgomery Asberg Depression Rating Scale MADRS score 12 at week 12 associated with lamotrigine monotherapy will exhibit a greater decrease in glutamate Glu and an increase in N-acetyl aspartate NAA reported as a cerebrospinal fluid CSF-corrected absolute concentration percent change from baseline to endpoint in anterior cingulate AC and dorsolateral prefrontal cortex DLPFC
The goal of this study was to better understand the neurobiology of bipolar depression and how lamotrigine may therapeutically impact brain function and mood response
The hypothesis was that in comparison to non-remission participants bipolar participants who achieve remission defined as a Montgomery Asberg Depression Rating Scale MADRS score 12 at week 12 associated with lamotrigine monotherapy will exhibit a greater decrease in glutamate Glu and an increase in N-acetyl aspartate NAA reported as a cerebrospinal fluid CSF-corrected absolute concentration percent change from baseline to endpoint in anterior cingulate AC and dorsolateral prefrontal cortex DLPFC
Detailed Description:
Depression is the predominant prevailing mood state in bipolar disorder and bipolar depression is associated with substantial morbidity and mortality However in comparison to acute mania bipolar depression is understudied both from the standpoint of its pathophysiology as well as clinical trials which include FDA-approved treatments Given this lack of evidence to base guidelines clinicians and patients are limited as to how best to treat the depressive phase of the illness
Proton magnetic resonance spectroscopy 1H-MRS is a valuable non-invasive method to study in-vivo brain biochemistry Of the novel imaging paradigms MRS is uniquely positioned to investigate biochemical mechanism of drug action that is objectively measurable and clinically relevant As there is increasing interest in glutamatergic dysregulation in mood disorders this project will utilize 1H-MRS to study glutamate and glutamine levels in brain regions implicated in bipolar disorder anterior cingulate and dorsolateral prefrontal cortex
This was a 5-year single-site study of bipolar depression utilizing 1H-MR spectroscopy before and after treatment with lamotrigine At baseline bipolar depressed subjects and age-matched controls underwent a 1H-MRS at Mayo Clinic in Rochester Minnesota The bipolar depressed subjects were then be placed on 12-week open evaluation of lamotrigine monotherapy After 12 weeks the bipolar subjects underwent a second 1H-MRS scan
Two different MRS sequences were used to measure the brain chemicals in a single 2 x 2 x 2 cm cube located in the center of anterior cingulate cortex an intermediate echo-time PRESS sequence and a 2D J-resolved averaged PRESS sequence Spectroscopic data were inspected for quality subjects whose data were contaminated by artifact were excluded from the study Spectra were then processed using LCModel to quantify brain chemical levels Regular brain MRI images were segmented yielding a map of the amount of CSF in the head The MRS cube was overlaid onto the CSF map and the fraction of CSF within the cube measured This measurement was used to remove the CSF from the MRS cube giving brain chemical concentrations The concentrations were then used for statistical analysis
Note All of the spectroscopy data are expressed in Institutional Units IU
Proton magnetic resonance spectroscopy 1H-MRS is a valuable non-invasive method to study in-vivo brain biochemistry Of the novel imaging paradigms MRS is uniquely positioned to investigate biochemical mechanism of drug action that is objectively measurable and clinically relevant As there is increasing interest in glutamatergic dysregulation in mood disorders this project will utilize 1H-MRS to study glutamate and glutamine levels in brain regions implicated in bipolar disorder anterior cingulate and dorsolateral prefrontal cortex
This was a 5-year single-site study of bipolar depression utilizing 1H-MR spectroscopy before and after treatment with lamotrigine At baseline bipolar depressed subjects and age-matched controls underwent a 1H-MRS at Mayo Clinic in Rochester Minnesota The bipolar depressed subjects were then be placed on 12-week open evaluation of lamotrigine monotherapy After 12 weeks the bipolar subjects underwent a second 1H-MRS scan
Two different MRS sequences were used to measure the brain chemicals in a single 2 x 2 x 2 cm cube located in the center of anterior cingulate cortex an intermediate echo-time PRESS sequence and a 2D J-resolved averaged PRESS sequence Spectroscopic data were inspected for quality subjects whose data were contaminated by artifact were excluded from the study Spectra were then processed using LCModel to quantify brain chemical levels Regular brain MRI images were segmented yielding a map of the amount of CSF in the head The MRS cube was overlaid onto the CSF map and the fraction of CSF within the cube measured This measurement was used to remove the CSF from the MRS cube giving brain chemical concentrations The concentrations were then used for statistical analysis
Note All of the spectroscopy data are expressed in Institutional Units IU
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH079261-01A2 | NIH | None | httpsreporternihgovquickSearchR01MH079261-01A2 |