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Clinical Trials in Israel / NCT00179465
Active, not recruiting Phase 3

Treating Schizophrenia by Correcting Abnormal Brain Development

NCT00179465 · tracked via the Priya Life Science Israel tracker
Sponsor
Beth Israel Deaconess Medical Center
Phase
Phase 3
Started
2003-11
Last updated
2025-01-27

Condition(s) studied

Schizophrenia

Investigational drug(s) / intervention(s)

TiagabinePlacebo

Tiagabine: Up to 36 mg daily

Placebo: Placebo

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
25 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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
    Working memory will be assessed using the n-back working memory test
  • 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
    Executive function, which is a complex form of working memory, will be assessed using the MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia) battery

Trial sites (1)

FacilityCityRegionStatus
Beth Israel Deaconess Medical Center Boston Massachusetts

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Other trials for the same condition

Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine Recruiting
CLOZAPINE Response in Biotype-1 Recruiting
European Long-acting Antipsychotics in Schizophrenia Trial-II Enrolling by invitation
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Cerebellar Modulation of Cognition in Psychosis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT00179465 on ClinicalTrials.gov ↗ ← All trials in Israel