Open label means people know they are on ITI 007, so part of this could be placebo effect, but this is still very encouraging:
"Consistent with good clinical care, patients were tapered down from their previous antipsychotic medication during the screening period or switched to lumateperone from one day to the next if no tapering down of the previous antipsychotic medication was clinically indicated. In this study, the most recent antipsychotic taken prior to screening, in descending order of frequency, included risperidone, quetiapine, aripiprazole, olanzapine, lurasidone, ziprasidone, haloperidol, paliperidone, perphenazine, asenapine, brexpiprazole and iloperidone.
The most frequent drug-related adverse event was somnolence occurring in 6.6% of patients receiving ITI-007 60 mg dosed daily in the evening. The proportion of patients reporting somnolence in this study was lower than that observed with morning dosing in previous lumateperone controlled trials and similar to that seen with placebo in those studies. There were no drug related serious adverse events. The proportion of patients experiencing motor side effects on lumateperone was low: akathisia (0.3%), and extrapyramidal side effects (0.7%). There were no signs of emerging extrapyramidal side effects, akathisia or dyskinesia as measured by the SAS, BARS or AIMS, respectively."