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Treating Schizophrenia by Correcting Abnormal Brain Development

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 27, 2025 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary and study completion dates: Sep 2024 to Sep 2026v13
  2. Primary and study completion dates: Sep 2022 to Sep 2024v12
  3. Secondary endpoints: details revised at 1 of 1 entryv11
  4. Primary and study completion dates: Sep 2019 to Sep 2022
    • Primary endpoints: 1 to 2
    • Secondary endpoints: details revised at 1 of 1 entry
    v10
  5. Primary completion date: Jul 2018 to Sep 2019
    • Study completion date: Jul 2019 to Sep 2019
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v8
  2. Primary completion date: Jul 2012 to Jul 2018
    • Study completion date: Jul 2019
    v7
  3. Primary completion date: Jul 2011 to Jul 2012v6
  4. Re-verified, no change to tracked fieldsv5
  5. Phase: Not applicable to Phase 3v4 Show 8 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 45 to 36
    • Primary completion date: Jul 2011
    • Interventions: Tiagabine (Gabitril) added onto antipsychotics (Drug) to Placebo (Drug), Tiagabine (Drug)
    • Secondary endpoints: details revised at 1 of 1 entry
    • Publications: 2 to 3
    • Study arms: 0 to 2
    • Collaborators expanded, about 3 words
  6. Re-verified, no change to tracked fieldsv3
  7. Eligibility criteria shortened, about 1 wordv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT00179465
Lead Sponsor Beth Israel Deaconess Medical Center
Collaborators: Dartmouth-Hitchcock Medical Center
Conditions
(from sponsor)		 Schizophrenia
Related terms Schizophrenia
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov