EPS, akathisia, and movement disorders1,2
For bipolar I and II depression in adults
Incidence of EPS* and akathisia were similar to placebo in 6‑week trials and not common in a 6‑month, open‑label safety trial1,2
Proportion of patients (%) experiencing EPS, akathisia, or dyskinesia1,2
Monotherapy: 6 weeks
Adjunctive
(with Lithium or Valproate): 6 weeks
Open-label,
monotherapy: 6 months
Proportion of patients (%) | CAPLYTA (n=372) | Placebo (n=374) | CAPLYTA (n=177) | Placebo (n=175) | CAPLYTA (n=127) |
|---|---|---|---|---|---|
EPS (including akathisia) | 1.3% | 1.1% | 4.0% | 2.3% | 1.6% (>1 EPS-related TEAE) |
Akathisia | 0.0% | 0.3% | 0.6% | 0.0% | 1.6% |
Dyskinesia | 0.0% |
Monotherapy: 6 weeks
Proportion of patients (%) | CAPLYTA (n=372) | Placebo (n=374) |
|---|---|---|
EPS (including akathisia) | 1.3% | 1.1% |
Akathisia | 0.0% | 0.3% |
Dyskinesia |
Adjunctive (with Lithium or Valproate): 6 weeks
Proportion of patients (%) | CAPLYTA (n=177) | Placebo (n=175) |
|---|---|---|
EPS (including akathisia) | 4.0% | 2.3% |
Akathisia | 0.6% | 0.0% |
Dyskinesia |
Open-label, monotherapy: 6 months
Proportion of patients (%) | CAPLYTA (n=127) |
|---|---|
EPS (including akathisia) | 1.6% (>1 EPS-related TEAE) |
Akathisia | 1.6% |
Dyskinesia | 0.0% |
Changes in movement scores were similar to placebo in 6‑week trials and not common in a 6‑month, open‑label safety trial1,2†
Change in movement scores from baseline1,2†
Monotherapy: 6 weeks
Adjunctive
(with Lithium or Valproate): 6 weeks
Open-label,
monotherapy: 6 months
Movement scores† | CAPLYTA (n=372) | Placebo (n=374) | CAPLYTA (n=177) | Placebo (n=175) | CAPLYTA (n=127) |
|---|---|---|---|---|---|
BARS | -0.1 | -0.1 | 0.0 | -0.1 | 0.0 |
AIMS | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
SAS | 0.0 | 0.0 | 0.0 | 0.0 | -0.1 |
Monotherapy: 6 weeks
Movement scores† | CAPLYTA (n=372) | Placebo (n=374) |
|---|---|---|
BARS | -0.1 | -0.1 |
AIMS | 0.0 | 0.0 |
SAS | 0.0 | 0.0 |
Adjunctive (with Lithium or Valproate): 6 weeks
Movement scores† | CAPLYTA (n=177) | Placebo (n=175) |
|---|---|---|
BARS | 0.0 | -0.1 |
AIMS | 0.0 | 0.0 |
SAS | 0.0 | 0.0 |
Open-label, monotherapy: 6 months
Movement scores† | CAPLYTA (n=127) |
|---|---|
BARS | 0.0 |
AIMS | 0.0 |
SAS | -0.1 |
EPS=extrapyramidal symptoms; TEAE=treatment-emergent adverse event; BARS=Barnes Akathisia Rating Scale; AIMS=Abnormal Involuntary Movement Scale; SAS=Simpson-Angus Scale.
*EPS include akathisia, extrapyramidal disorder, muscle spasms, restlessness, dyskinesia, tremor, movement disorder, and gait disturbance.1
†BARS ranges from 0-14. The AIMS for dyskinesia (total score ranges from 0 to 28). The SAS for EPS (total score ranges from 0 to 40). Movement scores represent mean change from baseline.
WARNINGS & PRECAUTIONS: Antipsychotic drugs have been reported to cause:
- Tardive Dyskinesia (TD) may develop in patients treated with antipsychotic drugs, including CAPLYTA. TD can develop after a relatively brief treatment period, even at low doses, or after treatment discontinuation. The TD risk appears to be highest in elderly women. The likelihood that TD will become irreversible increases with the duration of the antipsychotic drug treatment and cumulative dose. If signs and symptoms of TD appear, consider discontinuing CAPLYTA if clinically appropriate.
Please see additional Important Safety Information, including Boxed WARNINGS, below.
See 6‑week trials and 6‑month, open‑label safety trial weight and metabolic effects
