Treating Schizophrenia by Correcting Abnormal Brain Development

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00179465
Recruitment Status : Recruiting
First Posted : September 16, 2005
Last Update Posted : March 6, 2017
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Tsung-Ung Wilson Woo, Beth Israel Deaconess Medical Center

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.

This study is funded by the National Institutes of Health.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Tiagabine Drug: Placebo Phase 3

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 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : November 2003
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Antipsychotic plus study drug
Half of the subjects will receive the study medications in addition to their ongoing antipsychotic regimen.
Drug: Tiagabine
Up to 36 mg daily
Placebo Comparator: Antipsychotics plus placebo
Half of the subjects will receive placebo in addition to their antipsychotic regimen.
Drug: Placebo

Primary Outcome Measures :
  1. Neurocognitive Functions [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Clinical symptoms [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00179465

Contact: Noel Shaskan, B.A. 617-855-2381

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   
Principal Investigator: T.-U. Wilson Woo, M.D., Ph.D.         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Dartmouth-Hitchcock Medical Center
Principal Investigator: T.-U. Wilson Woo, M.D., Ph.D. Beth Israel Deaconess Medical Center, Harvard Medical School

Responsible Party: Tsung-Ung Wilson Woo, Assistant Professor of Psychiatry, Beth Israel Deaconess Medical Center Identifier: NCT00179465     History of Changes
Other Study ID Numbers: 2004P000078
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: March 2017

Keywords provided by Tsung-Ung Wilson Woo, Beth Israel Deaconess Medical Center:
Brain development

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
GABA Agonists
GABA Agents