Enlighten Early

The Enlighten Early Study is a large multicenter, Phase III, randomised, double-blind study looking to evaluate the effects of ALKS 3831 (samidorphan + olanzapine, developed by the sponsor, Alkermes) compared to olanzapine on body weight in young adults with schizophrenia, schizophreniform disorder or bipolar I disorder who are early in their illness.

One of the more common side-effects of many antipsychotics is weight gain. This study aims to investigate a reduction in weight gain by using a combination of olanzapine and samidorphan compared to olanzapine alone.

This study includes 9 to 11 study visits and approximately spans across 20 weeks, including: a 4-week screening period, a 12-week treatment period (patients treated with either “olanzapine” or “olanzapine + samidorphan”) and a 4-week follow-up period.

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The main criteria includes:

  • Ages 18 - 39
  • Very recent onset of schizophrenia, schizophreniform disorder or bipolar disorder I
  • Treated with less than 14 days of olanzapine or less than 16 weeks of antipsychotics (cumulative; lifetime)

For further information or to refer a patient, please contact: Cerena Miravalles, tel: 086 0081175, email: cerenakyanna.miravalles@nuigalway.ie