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Treating Schizophrenia by Correcting Abnormal Brain Development

This study is currently recruiting participants.
Verified July 2011 by Beth Israel Deaconess Medical Center
Sponsor:
Collaborator:
Dartmouth-Hitchcock Medical Center
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00179465
First received: September 12, 2005
Last updated: July 28, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention Phase
Schizophrenia
 Drug: Tiagabine
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Neurocognitive Functions [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: November 2003
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00179465

Contacts
Contact: Noel Shaskan, B.A. 617-855-2381 nshaskan@mclean.harvard.edu

Locations
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     wwoo@bidmc.harvard.edu    
Principal Investigator: T.-U. Wilson Woo, M.D., Ph.D.            
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: T.-U. Wilson Woo, M.D., Ph.D. Beth Israel Deaconess Medical Center, Harvard Medical School
  More Information

Publications:

Responsible Party: T.-U. W. Woo, M.D., Ph.D., Assistant Professor of Psychiatry, Harvard Medical School, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00179465     History of Changes
Other Study ID Numbers: 2004P-000078, 1R21MH082235-01A1
Study First Received: September 12, 2005
Last Updated: July 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
Treatment
fMRI
Cognition
Brain development

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Tiagabine
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Anticonvulsants
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Agonists
GABA Agents

ClinicalTrials.gov processed this record on May 16, 2013