Tolerability, Safety, and Effectiveness of Two Years of Treatment with Lurasidone in Children and Adolescents with Bipolar Depression

1. TOLERABILITY, SAFETY, AND EFFECTIVENESS OF TWO YEARS OF TREATMENT WITH LURASIDONE IN
CHILDREN AND ADOLESCENTS WITH BIPOLAR DEPRESSION
ANSWERING “PICO” (POPULATION, INTERVENTION, COMPARISON GROUP, OUTCOME)
SIU-School of Medicine
Franklin Alier, MD
PGY-2, Psychiatry

2. PICO (POPULATION, INTERVENTION, COMPARISON GROUP, OUTCOME)
Aim of the study:
Evaluate the long-term safety and effectiveness of lurasidone in children and adolescents with bipolar
depression.
Methods:
Participants ages 10-17 years old with bipolar depression who completed 6 weeks of double-blind
treatment with lurasidone or placebo, were enrolled in a 2 yearstudy of lurasidone 20-80 mg qday.
The primary effectiveness measure was the Children’s Depression Rating Scale, Revised (CDRS-R).
Results:
A total of 306 participants entered the 2 year study, 195 completed 52 weeks, and 168 completed 104
weeks.
Mean change in Children’s Depression Scale was -13.4 at week 52 and -16.3 at week 104. 31 participants
discontinued due to an adverse event (10.1%) (most common AE: headache, nausea and somnolence).

3. PICO (POPULATION, INTERVENTION, COMPARISON GROUP,
OUTCOME)
 Conclusions:
For youth with Bipolar depression, up to 2 years of treatment with lurasidone was generally well tolerated,
safe and effective with relatively low rates of discontinuation due to adverse effects on weight, metabolic
parameters or prolactin and continued improvement in depressive symptoms.

4. LINK TO ARTICLE
 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8568779/