Your session is about to expire
← Back to Search
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 belowSelect...
I have been taking second-generation antipsychotics for over 3 months.
Select...
I am between 18 and 25 years old and generally healthy.
Timeline
Screening ~ 3 weeks3 visits
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
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
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with schizophrenia in the last 3 years.I have a history of seizures or neurological disorders.I have been taking second-generation antipsychotics for over 3 months.I am HIV positive.I have tried two or more antipsychotic medications without success.I am between 18 and 25 years old and generally healthy.I have been diagnosed with schizoaffective disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Antipsychotic plus study drug
- Group 2: Antipsychotics plus placebo
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Share this study with friends
Copy Link
Messenger