[Skip to Navigation]
Views 718
Citations 0
Comment & Response
April 22, 2020

Effect Size and Blinding in Lumateperone Trial—Reply

Author Affiliations
  • 1Department of Psychiatry and Molecular Medicine, Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York
  • 2Department of Psychiatry, Zucker Hillside Hospital, Glen Oaks, New York
  • 3Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin Berlin, Berlin, Germany
  • 4Intra-Cellular Therapies Inc, New York, New York
JAMA Psychiatry. 2020;77(6):651-652. doi:10.1001/jamapsychiatry.2020.0613

In Reply We thank Gouse et al for raising 2 points regarding the efficacy and safety of lumateperone.1 The effect size of −0.30 for lumateperone, 42 mg, on the Positive and Negative Syndrome Scale total score is in the range of other recently approved antipsychotics: brexpiprazole (−0.26), cariprazine (−0.34), and lurasidone (−0.36).2 More recent trials of antipsychotics2,3 had higher placebo responses and therefore smaller effect size but not necessarily smaller improvement, which is what the patient and clinician would detect. Evaluated side by side in a separate study,4 lumateperone, 42 mg, and risperidone, 4 mg, a commonly used dose of a frequently prescribed antipsychotic, showed the same effect size of −0.4. The least-squares mean improvement from baseline in the Positive and Negative Syndrome Scale total score for lumateperone was similar in both studies (−14.5 in the current study1 vs −13.2 in the previous study4); only the placebo response differed (−10.3 in the current study1 vs −7.4 in the previous study4).

Limit 200 characters
Limit 25 characters
Conflicts of Interest Disclosure

Identify all potential conflicts of interest that might be relevant to your comment.

Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.

Err on the side of full disclosure.

If you have no conflicts of interest, check "No potential conflicts of interest" in the box below. The information will be posted with your response.

Not all submitted comments are published. Please see our commenting policy for details.

Limit 140 characters
Limit 3600 characters or approximately 600 words