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Clinical Studies

Two double-blind, randomized, placebo-controlled, six-week clinical trials established the efficacy of LATUDA for the treatment of adult patients with bipolar I disorder, both as monotherapy and as adjunctive therapy with lithium or valproate. Both studies showed that treatment with LATUDA resulted in statistically significant reductions in Montgomery-Åsberg Depression Rating Scale (MADRS) scores at 6 weeks compared to placebo.1,2

Download Overview

Lurasidone Monotherapy in the Treatment of Bipolar I Depression: A Randomized, Double-Blind, Placebo-Controlled Study

Loebel A, Cucchiaro J, Silva R, Kroger H, Hsu J, Sarma K, Sachs G.

Am J Psychiatry. 2014;171:160-168.

Objective1

  • Evaluate the efficacy and safety of LATUDA as monotherapy in the treatment of patients with major depressive episodes associated with bipolar I disorder

Study design1

  • Patients were randomized to receive double-blind treatment with LATUDA 20–60 mg/day
    (n=166), 80–120 mg/day (n=169), or placebo (n=170) for 6 weeks

Dosing1

  • Patients assigned to receive LATUDA underwent a fixed titration period for one week, before flexible dosing:
    • LATUDA 20–60 mg group: 20 mg/day for Days 1 to 7
    • LATUDA 80–120 mg group: 20 mg/day for Days 1 to 2; 40 mg/day for Days 3 to 4; 60 mg/day for Days 5 to 6; 80 mg/day on Day 7
  • Flexible dosing of LATUDA within the assigned dosing range was permitted after Day 7 at weekly intervals in 20-mg increments/decrements to optimize efficacy and tolerability
  • LATUDA or placebo was taken once daily in the evening, with a meal or within 30 minutes after eating

Endpoints1

  • Primary: Mean change from baseline to Week 6 in Montgomery-Åsberg Depression Rating Scale (MADRS) scores
  • Key secondary: Mean change from baseline to Week 6 in CGI-BP depression scores

Summary of results1

  • LATUDA 20–60 mg/day and 80–120 mg/day groups had significantly reduced mean MADRS total scores at Week 6 compared with the placebo group
  • LATUDA resulted in significantly greater reduction in CGI-BP depression scores at Week 6 compared with placebo
  • Discontinuation rates due to adverse events were similar in LATUDA 20–60 mg/day (6.6%) and
    80–120 mg/day (5.9%) groups and comparable to placebo group (6.5%)
  • Minimal changes in weight, lipids, and glucose were observed during treatment with LATUDA

Download Overview

 

Chapter 2: Study Design

Mood disorder specialist Dr. Joseph R. Calabrese describes the study design used in the LATUDA monotherapy clinical trial in this video.

References:
1. Loebel A, Cucchiaro J, Silva R, et al. Lurasidone monotherapy in the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014;171:160–168.
2. Loebel A, Cucchiaro J, Silva R, et al. Lurasidone as adjunctive therapy with lithium or valproate for the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014;171:169–177.

Lurasidone as Adjunctive Therapy With Lithium or Valproate for the Treatment of Bipolar I Depression: A Randomized, Double-Blind, Placebo-Controlled Study

Loebel A, Cucchiaro J, Silva R, Kroger H, Sarma K, Xu J, Calabrese J.

Am J Psychiatry. 2014;171:169-177.

Objective2

  • Evaluate the efficacy of LATUDA as adjunctive therapy with lithium or valproate for the treatment of bipolar I depression

Study design2

  • Patients who had not adequately responded to ≥28 days of lithium or valproate were randomized to receive 6 weeks of double-blind adjunctive treatment with LATUDA (n=183) or placebo (n=165) added to therapeutic levels of either lithium or valproate. At screening, serum levels for lithium and valproate were required to be 0.6­–1.2 mEq/L and 50–125 µg/mL, respectively.

Dosing2

  • Patients assigned to receive LATUDA underwent a fixed titration period for one week, before flexible dosing:
    • LATUDA 20 mg/day: Days 1 to 3
    • LATUDA 40 mg/day: Days 4 to 6
    • LATUDA 60 mg/day: Day 7
  • Flexible dosing of LATUDA within the dosing range of 20–120 mg/day was permitted after Day 7 in 20-mg increments/decrements
  • Mood stabilizer dose adjustments were permitted to maintain a serum level of 0.6–1.2 mEq/L for lithium or 50–125 µg/ml for valproate
  • LATUDA or placebo was taken once daily in the evening, with a meal or within 30 minutes after eating 

Endpoints2

  • Primary: Mean change from baseline to Week 6 in Montgomery-Åsberg Depression Rating Scale (MADRS) scores
  • Key secondary: Mean change from baseline to Week 6 in CGI-BP depression scores

Summary of results2

  • LATUDA 20–120 mg/day as adjunctive therapy with lithium or valproate significantly reduced mean MADRS total scores at Week 6 compared with placebo
  • LATUDA resulted in significantly greater reduction in CGI-BP depression scores at Week 6 compared with placebo
  • In the LATUDA and placebo groups, respectively, discontinuation rates due to adverse events were 6.0% and 7.9%
  • Minimal changes in weight, lipids, and glucose were observed during treatment with LATUDA

Download Overview


References:
1.
Loebel A, Cucchiaro J, Silva R, et al. Lurasidone monotherapy in the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014;171:160–168.
2. Loebel A, Cucchiaro J, Silva R, et al. Lurasidone as adjunctive therapy with lithium or valproate for the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014;171:169–177.

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR LATUDA

INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS

Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. LATUDA is not approved for the treatment of patients with dementia-related psychosis.

Suicidal Thoughts and Behaviors
Antidepressants increased the risk of suicidal thoughts and behaviors in patients aged 24 years and younger. Monitor for clinical worsening and emergence of suicidal thoughts and behavior. LATUDA is not approved for use in pediatric patients with depression.

 

CONTRAINDICATIONS: LATUDA is contraindicated in the following:

Cerebrovascular Adverse Reactions, Including Stroke: In clinical trials, elderly subjects with dementia randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke. LATUDA is not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS): NMS is a potentially fatal symptom complex, reported with administration of antipsychotic drugs. Clinical signs of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability. Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Manage NMS with immediate discontinuation of antipsychotic drugs, including LATUDA, intensive symptomatic treatment, and monitoring.

Tardive Dyskinesia (TD): The risk of developing TD (a syndrome of abnormal involuntary movements) and the potential for it to become irreversible are believed to increase as the duration of treatment and total cumulative dose of antipsychotic increase. The syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. There is no known treatment for established TD, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.

Metabolic Changes Atypical antipsychotic drugs have caused metabolic changes including:

Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. Patients with diabetes should be regularly monitored for worsening of glucose control; those with risk factors for diabetes should undergo fasting blood glucose testing at the beginning of and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.

Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.

Weight Gain: Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.

Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, LATUDA elevates prolactin levels. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds.

Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia/neutropenia has been reported with antipsychotics. Agranulocytosis (including fatal cases) has been reported with other agents in the class. Monitor complete blood count in patients with a pre-existing low white blood cell count (WBC)/absolute neutrophil count (ANC) or history of drug-induced leukopenia/neutropenia. Discontinue LATUDA at the first sign of a decline in WBC in the absence of other causative factors.

Orthostatic Hypotension and Syncope: Atypical antipsychotics cause orthostatic hypotension and syncope. Generally, the risk is greatest at the beginning of treatment and when increasing the dose. Monitor patients vulnerable to hypotension and those with cardiovascular and cerebrovascular disease.

Falls: Antipsychotics may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls causing fractures or other injuries. For patients with disease, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating treatment and recurrently during therapy.

Seizures: LATUDA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.

Potential for Cognitive and Motor Impairment: Patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that therapy with LATUDA does not affect them adversely.

Body Temperature Regulation: Use LATUDA with caution in patients who may experience conditions that increase body temperature (e.g., exercising strenuously, exposure to extreme heat, concomitant medication with anticholinergic activity, or being subject to dehydration).

Dysphagia: Antipsychotics, including LATUDA, have been associated with esophageal dysmotility and aspiration, and should be used with caution in patients at risk for aspiration pneumonia.

Most Commonly Observed Adverse Reactions: Commonly observed adverse reactions (≥5% incidence and at least twice the rate of placebo) for LATUDA:

To report SUSPECTED ADVERSE REACTIONS, contact Sunovion Pharmaceuticals Inc. at 877-737-7226 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).

Indications

LATUDA is indicated for:

Before prescribing LATUDA, please read the full Prescribing Information, including Boxed Warnings.