A Deep Dive into Clinical Trials and Effect Sizes
In a recent video, Dr. Leslie Citrome, a clinical professor of psychiatry and behavioral sciences at New York Medical College, discusses the efficacy and tolerability of lumateperone, a second-generation antipsychotic, in treating schizophrenia. Dr. Citrome delves into the clinical trials that have evaluated lumateperone and explains the importance of understanding effect sizes like “number needed to treat” (NNT) and “number needed to harm” (NNH) for better clinical decision-making.
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For physicians treating patients with schizophrenia, lumateperone offers a promising alternative with a favorable tolerability profile, particularly for those concerned about weight gain or akathisia. Understanding the NNT and NNH can provide valuable insights into the drug’s applicability in your practice, allowing for more personalized treatment plans.
- Lumateperone is the newest second-generation antipsychotic, and its efficacy and tolerability were evaluated by pooling together three different clinical trials.
- The NNT for lumateperone was in single digits, indicating a high likelihood of treatment success compared to placebo.
- Lumateperone showed minimal weight gain and no akathisia but did exhibit some degree of sedation or somnolence.
- Dr. Citrome emphasized the importance of understanding NNT and NNH to estimate a drug’s potential usefulness in day-to-day clinical work.
“In general, long-acting injectable antipsychotics, I think, are preferred and for the simple reason is that we no longer have to guess whether someone is taking their medicine or not.”
– Dr. Leslie Citrome, Clinical Professor of Psychiatry and Behavioral Sciences, New York Medical College
- Placebo groups in clinical trials also show improvement due to the structured care setting, making it crucial for the drug’s effect to be significantly better than the placebo effect.
- Second-generation antipsychotics, including lumateperone, generally have similar efficacy but differ in their tolerability profiles.
- Two new mechanisms of action for treating schizophrenia are under development, which could potentially eliminate the risk of tardive dyskinesia and other adverse effects.
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