Rankings / Mood, Anxiety & Stress
Lumateperone (Caplyta)
Mood, Anxiety & Stress · Atypical antipsychotic
Tier B
Bottom line
Read Off Label grades Lumateperone (Caplyta) as B (6.6/10) based on strong evidence, med-high benefit magnitude, and a med-risk safety profile.
Intra-Cellular Therapies/J&J.
Studied, labeled, or reported-use context: Oral 42 mg once daily — Rx; not individualized guidance.
What the evidence says
Intra-Cellular Therapies/J&J. FDA-approved Nov 2025 as adjunctive therapy for major depressive disorder (4th indication, after schizophrenia and bipolar I/II depression): two Phase 3 trials (n=485; n=480) showed MADRS improvements of 4.9 and 4.5 points vs placebo; weight/metabolic effects similar to placebo. Industry-sponsored.
Mechanism
Atypical antipsychotic with serotonin (5-HT2A antagonist), dopamine (presynaptic partial agonist / postsynaptic antagonist) and glutamatergic activity, and a comparatively clean metabolic profile.
Studied, labeled, or reported dose & route
Oral 42 mg once daily
This records doses and routes described in studies, approved labeling, clinical practice, or documented use. It is not individualized guidance and does not establish safety; context changes with indication, formulation, health history, monitoring, and other medicines.
Citations
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Common questions
- What does the evidence show about Lumateperone (Caplyta)'s effects?
- Read Off Label rates the evidence for Lumateperone (Caplyta) as Strong and the benefit magnitude as med-high, producing an overall grade of B (6.6/10). Intra-Cellular Therapies/J&J.
- What safety findings are reported for Lumateperone (Caplyta)?
- Lumateperone (Caplyta) has a med risk profile in the database. Med (somnolence, dry mouth; metabolic effects near placebo; antipsychotic-class warnings) Legal status: Rx (FDA-approved: schizophrenia, bipolar depression, MDD adjunct).
- What doses or routes are reported for Lumateperone (Caplyta)?
- Oral 42 mg once daily This is context from studies, approved labeling, clinical practice, or documented use; it is not individualized guidance and does not establish safety.
- How does Lumateperone (Caplyta) work?
- Atypical antipsychotic with serotonin (5-HT2A antagonist), dopamine (presynaptic partial agonist / postsynaptic antagonist) and glutamatergic activity, and a comparatively clean metabolic profile.
This is an independent synthesis of published research by a non-clinician. Scores are opinions supported by citations, not prescriptions. See the full disclaimer and methodology for how this score was produced and what it does and doesn't mean.