Treating Schizophrenia by Correcting Abnormal Brain Development
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|ClinicalTrials.gov Identifier: NCT00179465|
Recruitment Status : Active, not recruiting
First Posted : September 16, 2005
Last Update Posted : December 11, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Tiagabine Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Study Start Date :||November 2003|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
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.
- Neurocognitive Functions [ Time Frame: 6 months ]
- Clinical symptoms [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00179465
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||T.-U. Wilson Woo, M.D., Ph.D.||Beth Israel Deaconess Medical Center, Harvard Medical School|