For SCHIZOPHRENIA in adultsCAPLYTA demonstrated a significant reduction in PANSS total score in 4 weeks1-3

Change from baseline in PANSS total score over 4 weeks in Study 11,2*Change from baseline in PANSS total score over 4 weeks in Study 21
This graph illustrates the LSM change from baseline for patients receiving CAPLYTA 42 mg or placebo.This graph illustrates the LSM change from baseline for patients receiving CAPLYTA 42 mg or placebo.

13.2-point, significant improvement in PANSS total score at 4 weeks1,2

CAPLYTA separated from placebo in 1 week4

Weekly time points prior to 4 weeks were not powered for statistical comparison and are descriptive only. At 1 week, LSM change from baseline in PANSS total score was -4.0 points for CAPLYTA vs -2.6 points for placebo.4

This study was not designed to allow for efficacy comparison of CAPLYTA and risperidone. Risperidone was included for assay sensitivity.1,2

Baseline PANSS Total Scores: CAPLYTA 42 mg: 88.1; risperidone 4 mg: 86.1; placebo: 86.3.1,2

*The PANSS is a 30-item scale used to measure symptoms of schizophrenia. Each item is rated by a clinician on a 7-point scale. A score of 1 indicates the absence of symptoms, and a score of 7 indicates extremely severe symptoms. The PANSS total score may range from 30 to 210, with higher scores reflecting greater overall symptom severity.1

LSM=least squares mean; PANSS=Positive and Negative Syndrome Scale.

Baseline PANSS Total Scores: CAPLYTA 42 mg: 90.0; placebo: 89.0.1

LSM=least squares mean; PANSS=Positive and Negative Syndrome Scale.

The PANSS is a 30-item scale that measures the following symptoms1,2,5†:

Positive Subscale Symptoms:

  • Delusions
  • Hallucinations
  • Conceptual disorganization
  • Excitement
  • Grandiosity
  • Suspiciousness/persecution
  • Hostility

Negative Subscale Symptoms:

  • Blunted affect
  • Emotional withdrawal
  • Poor rapport
  • Passive/apathetic social withdrawal
  • Difficulty in abstract thinking
  • Lack of spontaneity and flow of conversation
  • Stereotyped thinking

General Psychopathology Subscale Symptoms:

  • Somatic concern
  • Anxiety
  • Guilt feelings
  • Tension
  • Mannerisms and posturing
  • Depression
  • Motor retardation
  • Uncooperativeness
  • Unusual thought content
  • Disorientation
  • Poor attention
  • Lack of judgement and insight
  • Disturbance of volition
  • Poor impulse control
  • Preoccupation
  • Active social avoidance

PANSS Prosocial Subscale

The PANSS Prosocial Subscale is a 6-item scale derived from the PANSS total score to measure social functioning. It includes the following symptoms:

  • Hallucinations
  • Suspiciousness/persecution
  • Emotional withdrawal
  • Passive/apathetic social withdrawal
  • Stereotyped thinking
  • Active social avoidance

†Each item is rated by a clinician on a 7-point scale. A score of 1 indicates the absence of symptoms, and a score of 7 indicates extremely severe symptoms. The PANSS total score may range from 30 to 210, with higher scores reflecting greater overall symptom severity.1,5

PANSS=Positive and Negative Syndrome Scale.

See CAPLYTA relapse data in schizophrenia
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References: 1. CAPLYTA Prescribing Information. 2. Lieberman JA, Davis RE, Correll CU, et al. CAPLYTA for the treatment of schizophrenia: a 4-week randomized, double-blind, controlled trial. Biol Psychiatry. 2016;79(12):952-961. doi: 10.1016/j.biopsych.2015.08.026 3. Correll CU, Davis RE, Weingart M, et al. Efficacy and safety of lumateperone for treatment of schizophrenia: a randomized clinical trial. JAMA Psychiatry. 2020;77(4):349-358. doi: 10.1001/jamapsychiatry.2019.4379 4. Data on File (REF-02886, REF-02887). 5. Shankar G, Nate C. Positive and Negative Syndrome Scale as a long-term outcome measurement tool in patients receiving clozapine ODT- A Pilot Study. Pharm Pract (Granada). 2007;5(1):42-45.

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