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Clinical Trial Details

Title
Protocol: ALK3831-A308 A Phase 3 Study to Assess the Long Term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 in Subjects with Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder
Study Purpose
The purpose of this study is to look at the long-term safety and tolerability (side effects) of ALKS 3831, and to see if it is effective in treating schizophrenia, schizophreniform disorder, and bipolar I disorder.
Study Plan
During this study, all subjects will take ALKS 3831 (the “study drug.”) We will monitor your schizophrenia/bipolar I disorder symptoms and overall health throughout the study. We will give you physical examinations, take samples of your blood and urine, monitor your heart, and ask you to fill out questionnaires. The study staff can explain any procedure that you do not understand. You should feel free to ask questions at any time.
Investigators

Principal Investigator
Steven P. Cuffe, M.D., FACPsych
Psychiatry

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