Clinical Trial 45971

Garden Grove, CA 92845



This study will 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

  • Has less than 24 weeks previous treatment with antipsychotics (cumulative; lifetime)

    • Subject treated with aripiprazole can receive an additional 1 year of treatment at ≤5 mg/day, and this treatment will not be considered as part of the 24 weeks of previous treatment with antipsychotics
  • Has less than 4 years elapse since the initial onset of active-phase of symptoms
  • Has a body mass index (BMI) of <30 kg/m^2
  • Agrees to use an acceptable method of contraception for the duration of the study and for 30 days after the last dose of study drug
  • Subject meets the criteria for a primary diagnosis of schizophrenia, schizophreniform disorder, or bipolar I disorder
  • For bipolar I disorder, must have been experiencing an episode of acute mania within ≤14 days prior to Visit 1
  • Suitable for outpatient treatment
  • Additional criteria may apply

Qualified Participants May Receive:

Monetary compensation for participating.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.