NCT00179465

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_3 schizophrenia

Timeline
4mo left

Started Nov 2003

Longer than P75 for phase_3 schizophrenia

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Nov 2003Sep 2026

Study Start

First participant enrolled

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
21 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

22.8 years

First QC Date

September 12, 2005

Last Update Submit

January 23, 2025

Conditions

Schizophrenia

Keywords

TreatmentfMRICognitionBrain development

Outcome Measures

Primary Outcomes (2)

  • Neurocognitive Functions-Working Memory

    Working memory will be assessed using the n-back working memory test

    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

  • Neurocognitive Functions-Executive Function

    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

    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

Secondary Outcomes (1)

  • Clinical symptoms

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

Study Arms (2)

Antipsychotic plus study drug

ACTIVE COMPARATOR

Half of the subjects will receive the study medications in addition to their ongoing antipsychotic regimen.

Drug: Tiagabine

Antipsychotics plus placebo

PLACEBO COMPARATOR

Half of the subjects will receive placebo in addition to their antipsychotic regimen.

Drug: Placebo

Interventions

TiagabineDRUG

Up to 36 mg daily

Also known as: Antipsychotic
Antipsychotic plus study drug
PlaceboDRUG

Placebo

Also known as: Antipsychotic
Antipsychotics plus placebo

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

  • Woo TU, Crowell AL. Targeting synapses and myelin in the prevention of schizophrenia. Schizophr Res. 2005 Mar 1;73(2-3):193-207. doi: 10.1016/j.schres.2004.07.022.

    PMID: 15653262BACKGROUND

  • Woo TU, Whitehead RE, Melchitzky DS, Lewis DA. A subclass of prefrontal gamma-aminobutyric acid axon terminals are selectively altered in schizophrenia. Proc Natl Acad Sci U S A. 1998 Apr 28;95(9):5341-6. doi: 10.1073/pnas.95.9.5341.

    PMID: 9560277BACKGROUND

  • Woo TU, Spencer K, McCarley RW. Gamma oscillation deficits and the onset and early progression of schizophrenia. Harv Rev Psychiatry. 2010 May-Jun;18(3):173-89. doi: 10.3109/10673221003747609.

    PMID: 20415633BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Interventions

TiagabineAntipsychotic Agents

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Nipecotic AcidsAcids, HeterocyclicHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-RingTranquilizing AgentsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic UsesPsychotropic Drugs

Study Officials

  • T.-U. Wilson Woo, M.D., Ph.D.

    Beth Israel Deaconess Medical Center, Harvard Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychiatry

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

November 1, 2003

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

January 27, 2025

Record last verified: 2025-01

Locations

US(1)