Study summary

The purpose of this study was to evaluate the efficacy of ASP4345 on cognitive impairment compared to placebo using change from baseline in MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite score (excluding social cognition domain). The primary estimand used a Hypothetical Strategy and compared participants as though the participant had continued on the assigned treatment and to evaluate the safety and tolerability of ASP4345 compared to placebo. This study also evaluated the effects of ASP4345 compared to placebo on functional capacity using the University of California San Diego Performance-based Skills Assessment-2 Extended Range (UPSA-2-ER) total score and evaluated the pharmacokinetic profile of ASP4345.

Additional Study Details

Phase
2
Product
  • ASP4345
  • placebo
  • risperidone
  • quetiapine
  • olanzapine
  • ziprasidone
  • aripiprazole
  • brexpiprazole
  • paliperidone
  • lurasidone
  • Type
    Interventional
    Masking
    Triple (Participant, Investigator, Outcomes Assessor)
    Enrollment number
    233
    Show Additional Study Details

    Study documents

    Scientific Results Summary
    Available Language(s): English
    Plain Language Summary
    Available Language(s): English
    Protocol
    Available Language(s): English
    Statistical Analysis Plan (SAP)
    Available Language(s): English

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    • Brazil
    • Bulgaria
    • Canada
    • Chile
    • China
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      Locations

      Contact Us
      Contact Us
      Completed
      California Neuropsychopharmacology Clinical Research Institute-LA, LLC
      Pico Rivera, CA, United States, 90660
      Completed
      Pacific Research Partners, LLC
      Oakland, CA, United States, 94607
      Completed
      InSite Clinical Research, LLC
      DeSoto, TX, United States, 75115
      Completed
      Cherry Street Services, Inc.
      Grand Rapids, MI, United States, 49503
      Completed
      Finger Lakes Clinical Research
      Rochester, NY, United States, 14618
      Completed
      New York State Psychiatric Institute
      New York, NY, United States, 10032
      Completed
      Pillar Clinical Research, LLC
      Richardson, TX, United States, 75080
      Completed
      Arch Clinical Trials, LLC
      St. Louis, MO, United States, 63118
      Completed
      CNS Research Science, Inc.
      Cerritos, CA, United States, 90703
      Completed
      Hassman Research Institute
      Berlin, NJ, United States, 08009
      Completed
      Uptown Research Institute
      Chicago, IL, United States, 60640
      Completed
      Artemis Institute for Clinical Research
      San Diego, CA, United States, 92103
      Completed
      Community Clinical Research, Inc.
      Austin, TX, United States, 78754
      Completed
      Midwest Clinical Research Center
      Dayton, OH, United States, 45417
      Completed
      Sharp Mesa Vista Hospital
      San Diego, CA, United States, 92123
      Completed
      Alam Medical Research Inc.
      Chicago, IL, United States, 60612
      Completed
      Atlanta Center for Medical Research
      Atlanta, GA, United States, 30331
      Completed
      Manhattan Psychiatric Center’s 125th Street Clinic
      New York, NY, United States, 10035
      Completed
      Michigan Clinical Research Institute PC
      Ann Arbor, MI, United States, 48105
      Withdrawn
      Woodland Research Northwest, LLC
      Rogers, AR, United States, 72758
      Completed
      SPRI Clinical Trials, LLC
      Brooklyn, NY, United States, 11235
      Completed
      CNS Research Science, Inc.
      Jamaica, NY, United States, 11432
      Completed
      Synergy East
      Lemon Grove, CA, United States, 91945
      Completed
      Albuquerque Neuroscience Inc.
      Albuquerque, NM, United States, 87109
      Completed
      Collaborative Neuroscience Network, LLC
      Torrance, CA, United States, 90502
      Completed
      Collaborative Neuroscience Network, LLC
      Garden Grove, CA, United States, 92845
      Completed
      California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego)
      San Diego, CA, United States, 92102
      Completed
      Radiant Research, Inc.
      Atlanta, GA, United States, 30328
      Withdrawn
      Pillar Clinical Research, LLC
      Garland, TX, United States, 75042

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