What is the recommended treatment for bipolar 1 disorder using Latuda (lurasidone)?

Lurasidone (Latuda) for Bipolar I Disorder

Lurasidone is FDA-approved for the treatment of bipolar depression in adults and pediatric patients (10-17 years) as monotherapy or as adjunctive therapy with lithium or valproate, with a recommended starting dose of 20 mg once daily taken with food. 1

Dosing and Administration

• Starting dose: 20 mg once daily (for both adults and pediatric patients 10-17 years)
• Effective dose range:
  • Adults: 20-120 mg/day (monotherapy or adjunctive with lithium/valproate)
  • Pediatric patients: 20-80 mg/day (monotherapy)
• Administration: Must be taken with food (at least 350 calories) as food increases absorption approximately 2-fold 1
• Dose adjustments: For moderate to severe renal impairment, start at 20 mg/day with maximum of 80 mg/day 1

Efficacy for Bipolar I Disorder

Lurasidone is effective specifically for the depressive episodes of bipolar I disorder:

• It has demonstrated significant efficacy for bipolar depression with clinically meaningful treatment effect sizes (0.51 for monotherapy, 0.34 for adjunctive therapy) 2
• Number needed to treat (NNT) for response with monotherapy is 5, and for remission is 6-7 2
• Lurasidone is ranked second highest for response rate among treatments for bipolar depression 3
• Important note: Lurasidone has not been studied or approved for treatment of mania or bipolar psychosis 2

Advantages of Lurasidone

1. Weight-neutral profile: Unlike many other antipsychotics used for bipolar disorder, lurasidone is generally weight-neutral 4
2. Lower hospitalization risk: When used as adjunctive therapy with mood stabilizers, lurasidone is associated with significantly lower all-cause and psychiatric hospitalization rates compared to olanzapine, quetiapine, and ziprasidone 5
3. Favorable metabolic profile: This is particularly important as people with bipolar disorder have higher rates of metabolic syndrome (37%), obesity (21%), and type 2 diabetes (14%) 6

Treatment Algorithm for Bipolar I Disorder

1. For acute bipolar depression:

   • First-line options include lurasidone monotherapy (20-120 mg/day) or adjunctive therapy with lithium or valproate 4, 1
   • Other first-line options include lamotrigine, quetiapine, lithium, or olanzapine-fluoxetine combination 4

2. For maintenance therapy:

   • The effectiveness of lurasidone for longer-term use (beyond 6 weeks) has not been established in controlled studies 1
   • Physicians should periodically re-evaluate the long-term usefulness for individual patients 1
   • Standard maintenance therapy typically includes lithium or valproate for at least 2 years after the last episode 4

Clinical Considerations and Monitoring

• Safety warnings: Increased mortality risk in elderly patients with dementia-related psychosis; increased risk of suicidal thoughts and behaviors (particularly in young adults) 1
• Regular monitoring: Clinical assessment of mood symptoms, medication adherence, and side effects
• Laboratory monitoring: Regular assessment of:
  • Metabolic parameters (weight, BMI, blood pressure, fasting glucose, lipid panel)
  • Thyroid, renal, and liver function
  • Complete blood count 4

Important Caveats

1. Not approved for mania: Lurasidone's efficacy in the treatment of mania has not been established 1, 2
2. Food requirement: Administration without food significantly reduces absorption, potentially compromising efficacy 1
3. Limited long-term data: Efficacy beyond 6 weeks has not been established in controlled studies 1
4. Suicide risk: Bipolar disorder carries a high suicide risk (annual rate ~0.9%), with risk highest during depressive episodes 4, 6

Lurasidone represents an important treatment option for bipolar depression with advantages of weight neutrality and lower hospitalization risk compared to some other atypical antipsychotics, making it particularly valuable for patients with metabolic concerns.