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A Study to Evaluate the Effect of ALKS 3831 Compared to Olanzapine on Body Weight in Young Adults With Schizophrenia, Schizophreniform, or Bipolar I Disorder Who Are Early in Their Illness

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Trial Profile

A Study to Evaluate the Effect of ALKS 3831 Compared to Olanzapine on Body Weight in Young Adults With Schizophrenia, Schizophreniform, or Bipolar I Disorder Who Are Early in Their Illness

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Sep 2019

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At a glance

  • Drugs Olanzapine/samidorphan (Primary) ; Olanzapine
  • Indications Bipolar I disorders; Psychotic disorders; Schizophrenia
  • Focus Registrational; Therapeutic Use
  • Acronyms ENLIGHTEN-Early
  • Sponsors Alkermes plc

    • Most Recent Events

    • 26 Jul 2019 Planned number of patients changed from 350 to 425.
    • 26 Jul 2019 Planned End Date changed from 1 Nov 2019 to 1 Dec 2021.
    • 26 Jul 2019 Planned primary completion date changed from 1 Oct 2019 to 1 Nov 2021.
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