Treating Schizophrenia by Correcting Abnormal Brain Development
NCT ID: NCT00179465
Last Updated: 2025-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
36 participants
INTERVENTIONAL
2003-11-30
2026-09-30
Brief Summary
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This study is funded by the National Institutes of Health.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Antipsychotic plus study drug
Half of the subjects will receive the study medications in addition to their ongoing antipsychotic regimen.
Tiagabine
Up to 36 mg daily
Antipsychotics plus placebo
Half of the subjects will receive placebo in addition to their antipsychotic regimen.
Placebo
Placebo
Interventions
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Tiagabine
Up to 36 mg daily
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently on second-generation antipsychotics for at least 3 months.
* Age 18-25, otherwise healthy.
Exclusion Criteria
* 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.
18 Years
25 Years
ALL
No
Sponsors
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Dartmouth-Hitchcock Medical Center
OTHER
Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Tsung-Ung Wilson Woo
Assistant Professor of Psychiatry
Principal Investigators
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T.-U. Wilson Woo, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center, Harvard Medical School
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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References
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Woo TU, Crowell AL. Targeting synapses and myelin in the prevention of schizophrenia. Schizophr Res. 2005 Mar 1;73(2-3):193-207. doi: 10.1016/j.schres.2004.07.022.
Woo TU, Whitehead RE, Melchitzky DS, Lewis DA. A subclass of prefrontal gamma-aminobutyric acid axon terminals are selectively altered in schizophrenia. Proc Natl Acad Sci U S A. 1998 Apr 28;95(9):5341-6. doi: 10.1073/pnas.95.9.5341.
Woo TU, Spencer K, McCarley RW. Gamma oscillation deficits and the onset and early progression of schizophrenia. Harv Rev Psychiatry. 2010 May-Jun;18(3):173-89. doi: 10.3109/10673221003747609.
Other Identifiers
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2004P000078
Identifier Type: -
Identifier Source: org_study_id
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