Treating Schizophrenia by Correcting Abnormal Brain Development
Verified March 2017 by Tsung-Ung Wilson Woo, Beth Israel Deaconess Medical Center
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Tsung-Ung Wilson Woo, Beth Israel Deaconess Medical Center
First received: September 12, 2005
Last updated: March 2, 2017
Last verified: March 2017
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.
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
||Addition of Tiagabine to Second-Generation Antipsychotics in the Treatment of Recent-Onset Schizophrenia by Modification of Developmental Reorganization of the Prefrontal Cortex
Primary Outcome Measures:
- Neurocognitive Functions [ Time Frame: 6 months ]
Secondary Outcome Measures:
- Clinical symptoms [ Time Frame: 6 months ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2018 (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.
|Ages Eligible for Study:
||18 Years to 25 Years (Adult)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00179465
|Beth Israel Deaconess Medical Center
|Boston, Massachusetts, United States, 02115 |
|Contact: T.-U. Wilson Woo, M.D., Ph.D. 617-855-2823 firstname.lastname@example.org |
|Principal Investigator: T.-U. Wilson Woo, M.D., Ph.D. |
Beth Israel Deaconess Medical Center
Dartmouth-Hitchcock Medical Center
||T.-U. Wilson Woo, M.D., Ph.D.
||Beth Israel Deaconess Medical Center, Harvard Medical School
Woo, TUW, Spencer KS, McCarley RW. Gamma oscillations and the early course and progression of schizophrenia. Harvard Review of Psychiatry 2009.
||Tsung-Ung Wilson Woo, Assistant Professor of Psychiatry, Beth Israel Deaconess Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 12, 2005
||March 2, 2017
Keywords provided by Tsung-Ung Wilson Woo, Beth Israel Deaconess Medical Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 25, 2017
Schizophrenia Spectrum and Other Psychotic Disorders
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Central Nervous System Depressants