Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00179465
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-07
First Post:
2005-09-12
Brief Title:
Treating Schizophrenia by Correcting Abnormal Brain Development
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
Addition of Tiagabine to Second-Generation Antipsychotics in the Treatment of Recent-Onset Schizophrenia by Modification of Developmental Reorganization of the Prefrontal Cortex
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-06
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:
None
Brief Summary:
The purpose of this study is to determine whether treatment with tiagabine Gabitril during the early course of schizophrenia can fundamentally correct the brain deficits associated with the disease
This study is funded by the National Institutes of Health
This study is funded by the National Institutes of Health
Detailed Description:
It is hypothesized that enhancement of GABA neurotransmission during the early course of the illness by tiagabine Gabitril a GABA transporter GAT-1-specific inhibitor and a FDA-approved anticonvulsant will improve both clinical symptoms and working memory in schizophrenia This improvement is postulated to be the result of tiagabine-mediated modification of the developmental synaptic pruning of prefrontal cortical circuitry The occurrence of circuitry modification after tiagabine treatment will be assessed by the following independent methodologic approaches MRI morphometric analysis of prefrontal gray matter volume and fMRI measurements of brain activity patterns during performance of tasks that probe working memory
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