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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

  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 entryv10 Show 2 more changesShow less
    • Primary endpoints: 1 to 2
    • Secondary endpoints: details revised at 1 of 1 entry

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date: Jul 2018 to Sep 2019 Completion date: Jul 2019 to Sep 2019v9 Show 1 more changeShow less
    • Completion date: Jul 2019 to Sep 2019
Show 7 earlier versionsHide 7 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Site details revisedv8 Show 1 more changeShow less
    • Site details revised
  2. Primary completion date: Jul 2012 to Jul 2018 Completion date: Jul 2019v7 Show 1 more changeShow less
    • Completion date: Jul 2019
  3. Primary completion date: Jul 2011 to Jul 2012v6
  4. Re-verified, no change to tracked fieldsv5
  5. Phase: Not applicable to Phase 3 Primary endpoint revised · Enrollment target: 45 to 36 · Primary completion date: Jul 2011 · 5 morev4 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

    See this version in full on ClinicalTrials.gov ↗

  6. Re-verified, no change to tracked fieldsv3
  7. Eligibility criteria shortened, about 1 wordv2 See this version in full on ClinicalTrials.gov ↗
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Schizophrenia
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov