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OpenTrials
Active, Not Recruiting

NCT Number: NCT00179465

Treating Schizophrenia by Correcting Abnormal Brain Development

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

About this study

It is hypothesized that enhancement of GABA neurotransmission during the early course of the illness by tiagabine (Gabitril), a GABA transporter GAT-1-specific inhibitor and a FDA-approved anticonvulsant, will improve both clinical symptoms and working memory in schizophrenia. This improvement is postulated to be the result of tiagabine-mediated modification of the developmental synaptic pruning of prefrontal cortical circuitry. The occurrence of circuitry modification after tiagabine treatment will be assessed by the following independent methodologic approaches: MRI morphometric analysis of prefrontal gray matter volume and fMRI measurements of brain activity patterns during performance of tasks that probe working memory.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tiagabine

Drug

Up to 36 mg daily

Other names: Antipsychotic

Placebo

Drug

Placebo

Other names: Antipsychotic

Primary outcomes

  1. Neurocognitive Functions-Working Memory

    Time frame: 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

  2. Neurocognitive Functions-Executive Function

    Time frame: 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

Secondary outcomes

  1. Clinical symptoms

    Time frame: Symptoms will be assessed at baseline and at 6-month time point to see if symptoms change after 6 months compared to baseline measures

    Positive and negative symptoms will be quantified using PANSS (positive and negative symptom scale)

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Dartmouth-Hitchcock Medical Center

Registry information

Official study title

Addition of Tiagabine to Second-Generation Antipsychotics in the Treatment of Recent-Onset Schizophrenia by Modification of Developmental Reorganization of the Prefrontal Cortex

Important dates

Study start
2003
Primary completion
2026
Study completion
2026
First posted
Sep 16, 2005
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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