Tiagabine for Schizophrenia

Recruiting in Palo Alto (17 mi)

Overseen ByT.-U. Wilson Woo, M.D., Ph.D.

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Beth Israel Deaconess Medical Center

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for young adults aged 18-25 who have been diagnosed with schizophrenia within the last three years and are on second-generation antipsychotics. It's not for those with schizoaffective disorder, multiple failed antipsychotic trials, neurological disorders, pregnancy, HIV, suicidal tendencies or substance dependence.

Inclusion Criteria

I was diagnosed with schizophrenia in the last 3 years.

I have been taking second-generation antipsychotics for over 3 months.

I am between 18 and 25 years old and generally healthy.

Exclusion Criteria

I have a history of seizures or neurological disorders.

Actively suicidal

I am HIV positive.

+6 more

Participant Groups

The study tests if tiagabine can correct brain deficits in early-stage schizophrenia compared to a placebo. Participants will be randomly assigned to receive either tiagabine or an inactive pill without knowing which one they're getting.

2Treatment groups

Active Control

Placebo Group

Group I: Antipsychotic plus study drugActive Control1 Intervention

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

Group II: Antipsychotics plus placeboPlacebo Group1 Intervention

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