Treating Schizophrenia by Correcting Abnormal Brain Development

Addition of Tiagabine to Second-Generation Antipsychotics in the Treatment of Recent-Onset Schizophrenia by Modification of Developmental Reorganization of the Prefrontal Cortex

Sponsors

Lead Sponsor: Beth Israel Deaconess Medical Center

Collaborator: Dartmouth-Hitchcock Medical Center

Source 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.

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.

Overall Status Active, not recruiting
Start Date 2003-11-01
Completion Date 2022-09-01
Primary Completion Date 2022-09-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Neurocognitive Functions-Working Memory Working memory will be assessed at baseline and at 6-month time point to see if working memory changes after 6 months compared to baseline measurement
Neurocognitive Functions-Executive Function Executive function will be assessed at baseline and at 6-month time point to see if executive function changes after 6 months compared to baseline measure
Secondary Outcome
Measure Time Frame
Clinical symptoms Symptoms will be assessed at baseline and at 6-month time point to see if symptoms change after 6 months compared to baseline measures
Enrollment 36
Condition
Intervention

Intervention Type: Drug

Intervention Name: Tiagabine

Description: Up to 36 mg daily

Arm Group Label: Antipsychotic plus study drug

Other Name: Antipsychotic

Intervention Type: Drug

Intervention Name: Placebo

Description: Placebo

Arm Group Label: Antipsychotics plus placebo

Other Name: Antipsychotic

Eligibility

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

25 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
T.-U. Wilson Woo, M.D., Ph.D. Principal Investigator Beth Israel Deaconess Medical Center, Harvard Medical School
Location
Facility: Beth Israel Deaconess Medical Center
Location Countries

United States

Verification Date

2021-05-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Beth Israel Deaconess Medical Center

Investigator Full Name: Tsung-Ung Wilson Woo

Investigator Title: Assistant Professor of Psychiatry

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Antipsychotic plus study drug

Type: Active Comparator

Description: Half of the subjects will receive the study medications in addition to their ongoing antipsychotic regimen.

Label: Antipsychotics plus placebo

Type: Placebo Comparator

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News