Treating Schizophrenia by Correcting Abnormal Brain Development

NCT ID: NCT00179465

Last Updated: 2025-01-27

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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.

Group Type ACTIVE_COMPARATOR

Tiagabine

Intervention Type DRUG

Up to 36 mg daily

Antipsychotics plus placebo

Half of the subjects will receive placebo in addition to their antipsychotic regimen.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Tiagabine

Up to 36 mg daily

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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Antipsychotic Antipsychotic

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Tsung-Ung Wilson Woo

Assistant Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 15653262 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9560277 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20415633 (View on PubMed)

Other Identifiers

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2004P000078

Identifier Type: -

Identifier Source: org_study_id

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