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Switching Medication to Treat Schizophrenia

StatusCompleted
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Secondary endpoint revised

    Show what changed: Secondary endpoints
    PsychiatricNumber Symptoms,of Hospitalization,Participants and Medication Side EffectsHospitalized

    Study Status, Sponsor/Collaborators, Outcome Measures, Baseline Characteristics, Outcome Measures (Results)v16

  2. Minor

    Enrollment target: 280 to 219

    Study sites: 16 to 0

    Study Identification, Study Status, Study Design, Outcome Measures, Contacts/Locations, Outcome Measures (Results)v15

  3. Minor

    Study Status, Arms and Interventions, Baseline Characteristics

    Re-verified, no change to tracked fields

    v14

  4. Notable

    Lead sponsor: National Institute of Mental Health (NIMH) to Icahn School of Medicine at Mount Sinai

    Results first posted: Dec 5, 2013; Primary endpoint revised; Trial status: Active, Not Recruiting to Completed; and 6 more

    Show all 10 changes in this update
    • Notable Lead sponsor: National Institute of Mental Health (NIMH) to Icahn School of Medicine at Mount Sinai
    • Notable Results first posted: Dec 5, 2013
    • Notable Primary endpoint revised
      Show what changed
      TimeNumber toWho medicationDiscontinued discontinuationMedication Within First 6 Study Months
    • Minor Trial status: Active, Not Recruiting to Completed
    • Minor Enrollment target: estimated 300 to confirmed 280
    • Minor Primary completion date changed from estimate of Apr 2009 to Mar 2009
    • Minor Study completion date changed from estimate of May 2009 to Mar 2009
    • Minor Secondary endpoint revised
      Show what changed
      Psychiatric symptomsSymptoms, hospitalizationHospitalization, and medicationMedication sideSide effectsEffects
    • Minor Collaborators expanded, about 6 words
      Show what changed
      National Institute of Mental Health (NIMH)
    • Minor Publications: details revised at 2 of 2 entries

    Study Identification, Study Status, Sponsor/Collaborators, Study Design, Outcome Measures, References, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Informationv13

  5. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Site details revised at 16 of 16 sites

    Study Status, Contacts/Locationsv12

Show 10 earlier versions

  1. Minor

    Primary completion date: Apr 2009

    Completion date: May 2009; Site details revised at 7 of 16 sites; Study arms: 0 to 2

    Study Status, Sponsor/Collaborators, Oversight, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locationsv11

  2. Minor

    Site contacts updated at 2 of 16 sites

    Study Status, Contacts/Locationsv10

  3. Minor

    Site contacts updated at 1 of 16 sites

    Study Status, Study Design, Contacts/Locationsv9

  4. Minor

    Site details revised at 1 of 16 sites

    Study Status, Contacts/Locationsv8

  5. Minor

    Study sites: 17 to 16

    Eligibility criteria revised

    Show what changed: Eligibility criteria
    [...] services from a crisis intervention program within the past 63 months Require placement in a skilled nursing facility as a [...]

    Study Status, Eligibility, Contacts/Locationsv7

  6. Minor

    Study sites: 14 to 17

    Study Status, Contacts/Locationsv6

  7. Minor

    Study sites: 12 to 14

    Study description revised

    Show what changed: Study description
    [...] table will begin taking long-acting injectable risperidone (RisperidolRisperdal Consta). Participants currently taking two antipsychotic me [...]

    Study Status, Study Description, Contacts/Locationsv5

  8. Minor

    Study Identification, Study Status

    Re-verified, no change to tracked fields

    v4

  9. Minor

    Study sites: 13 to 12

    Study Status, Contacts/Locationsv3

  10. Minor

    Study sites: 1 to 13

    Start date: Jul 2001; Eligibility criteria expanded, about 1 word; Study description expanded, about 77 words

    Show what changed: Eligibility criteria
    [...] hotic medications for at least 2 months Received at least 1 Medicaidoutpatient mental health service every 3 months for the past 6 months Exclusion crit [...] talization within the past 3 months Received services from a DMHAS crisis intervention program within the past 6 months Requir [...]
    Show what changed: Study description
    [...] prescribing for relatively stable outpatients. Participants arewill be randomly assigned to receiveeither continue taking their current medications for schizophrenia, or to switch to a new medication. Participants assigned to switch to a new medication will begin receiving either olanzapine (Zyprexa), risperidone (Risperdal), ziprasidone (Geodon), quetiapine (Seroquel), or aripiprazole (Abilify), depending on what they are currently taking. Participants currently taking a single oral medication will switch to olanzapine, risperidone, ziprasidone, quetiapine, or toaripiprazole. Participants rem [...] [...]

    Study Identification, Study Status, Study Description, Eligibility, Contacts/Locationsv2

  1. Minor

    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.
This study will evaluate the effectiveness of switching medications in decreasing schizophrenia symptoms in individuals who are currently taking an antipsychotic medication for the treatment of schizophrenia.
Trial Details
NCT Number NCT00044655
Lead Sponsor Icahn School of Medicine at Mount Sinai
Collaborators: National Institute of Mental Health (NIMH)
Conditions Schizophrenia
Enrollment 219 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov