The Kalea Trial is evaluating the effectiveness and safety of an investigational treatment for adults with MDD who are currently in a depressive episode lasting at least 1 month to no more than 2 years, have previously had at least 1 depressive episode, and have tried at least 1 oral (by mouth) antidepressant.
During the trial treatment period, participants will be randomly assigned to 1 of 2 groups to receive either the investigational treatment or a placebo (a substance that looks like the investigational treatment but contains no active ingredients), both given as injections. Eligible participants may also take part in an open-label extension period, during which all participants will receive the investigational treatment. Participants will not be expected to do anything at home throughout the trial.
Total participation will include up to 10 trial visits over the course of approximately 28 weeks. Some visits will take place virtually.
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