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GABA Reuptake Inhibitor

Tiagabine for Schizophrenia

Phase 3
Waitlist Available
Led By T.-U. Wilson Woo, M.D., Ph.D.
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Currently on second-generation antipsychotics for at least 3 months
Age 18-25, otherwise healthy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up symptoms will be assessed at baseline and at 6-month time point to see if symptoms change after 6 months compared to baseline measures
Awards & highlights

Study Summary

This trial will test whether tiagabine can improve brain function in people with early schizophrenia.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Tiagabine may cause side effects like dizziness, fatigue, nausea, confusion and potentially worsen seizures in people prone to them. The placebo should not cause any direct side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been taking second-generation antipsychotics for over 3 months.
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I am between 18 and 25 years old and generally healthy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Neurocognitive Functions-Executive Function
Neurocognitive Functions-Working Memory
Secondary outcome measures
Clinical symptoms

Trial Design

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.

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
836 Previous Clinical Trials
13,010,300 Total Patients Enrolled
21 Trials studying Schizophrenia
1,966 Patients Enrolled for Schizophrenia
Dartmouth-Hitchcock Medical CenterOTHER
524 Previous Clinical Trials
2,543,305 Total Patients Enrolled
32 Trials studying Schizophrenia
4,182 Patients Enrolled for Schizophrenia
T.-U. Wilson Woo, M.D., Ph.D.Principal InvestigatorBeth Israel Deaconess Medical Center, Harvard Medical School

Media Library

Tiagabine (GABA Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00179465 — Phase 3
Schizophrenia Research Study Groups: Antipsychotic plus study drug, Antipsychotics plus placebo
Schizophrenia Clinical Trial 2023: Tiagabine Highlights & Side Effects. Trial Name: NCT00179465 — Phase 3
Tiagabine (GABA Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00179465 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~1 spots leftby Sep 2024