Tiagabine for Schizophrenia

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Beth Israel Deaconess Medical Center

Must be taking: Second-generation antipsychotics

Disqualifiers: Schizoaffective, Seizures, Substance dependence, others

Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires participants to be on second-generation antipsychotics for at least 3 months. It seems you may need to continue your current antipsychotic medication.

What evidence supports the effectiveness of the drug Tiagabine for treating schizophrenia?

While there is no direct evidence for Tiagabine in treating schizophrenia, similar drugs like Topiramate have shown effectiveness in reducing symptoms in patients with schizophrenia, suggesting potential benefits of Tiagabine due to its similar action on neurotransmitter systems.¹ ² ³ ⁴ ⁵

How does the drug Tiagabine differ from other treatments for schizophrenia?

Tiagabine is unique because it is primarily used to treat epilepsy by increasing the levels of GABA (a calming neurotransmitter) in the brain, which may offer a novel approach for managing schizophrenia symptoms compared to traditional antipsychotics that target dopamine pathways.¹ ⁶ ⁷ ⁸ ⁹

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.

Research Team

T.-U. Wilson Woo, M.D., Ph.D.

Principal Investigator

Beth Israel Deaconess Medical Center, Harvard Medical School

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.

Exclusion Criteria

I have a history of seizures or neurological disorders.

Actively suicidal

I am HIV positive.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tiagabine or placebo in addition to their antipsychotic regimen

6 months

Regular visits for medication administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

Placebo
Tiagabine

Trial Overview 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.

Participant Groups

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.