Status:
ACTIVE_NOT_RECRUITING
Treating Schizophrenia by Correcting Abnormal Brain Development
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Dartmouth-Hitchcock Medical Center
Conditions:
Schizophrenia
Eligibility:
All Genders
18-25 years
Phase:
PHASE3
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....
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 anticonvuls...
Eligibility Criteria
Inclusion
- Meets criteria for the diagnosis of schizophrenia, with onset of psychotic symptoms within the past 3 years.
- Currently on second-generation antipsychotics for at least 3 months.
- Age 18-25, otherwise healthy.
Exclusion
- Diagnosis of schizoaffective disorder.
- Has failed two or more clinically adequate antipsychotic trials.
- History of seizures or any neurologic disorders.
- Pregnant or nursing women.
- Known HIV infection.
- Actively suicidal.
- History of any substance dependence.
- Currently meets criteria for substance abuse/dependence.
- Other MRI exclusion criteria per Radiology Department protocols.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00179465
Start Date
November 1 2003
End Date
September 1 2026
Last Update
January 27 2025
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115