Treating Schizophrenia by Correcting Abnormal Brain Development
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|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|
- Neurocognitive Functions [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Clinical symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||November 2003|
|Estimated Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Antipsychotic plus study drug
Half of the subjects will receive the study medications in addition to their ongoing antipsychotic regimen.
Up to 36 mg daily
Placebo Comparator: Antipsychotics plus placebo
Half of the subjects will receive placebo in addition to their antipsychotic regimen.
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.
|Contact: Noel Shaskan, B.A.||firstname.lastname@example.org|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: T.-U. Wilson Woo, M.D., Ph.D. 617-855-2823 email@example.com|
|Principal Investigator: T.-U. Wilson Woo, M.D., Ph.D.|
|Principal Investigator:||T.-U. Wilson Woo, M.D., Ph.D.||Beth Israel Deaconess Medical Center, Harvard Medical School|