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Bipolar depression can disrupt and devastate lives

Accurate diagnosis and treatment can make a difference

 

Bipolar depression is commonly misdiagnosed 

60% of adults misdiagnosed were misdiagnosed with unipolar depression1

Unipolar depression is the most common misdiagnosis, followed by anxiety disorders, schizophrenia, personality disorders, and substance- or alcohol-abuse disorders1

  • Depressive symptoms of unipolar depression are the same as those of bipolar depression2

There are consequences to treatment delays

Delayed diagnosis and treatment can have consequences for patients

 

Many patients wait 10+ years from symptom onset before accurate diagnosis or evidence-based treatment for bipolar disorder1,3

 

Many patients wait 10+ years from symptom onset before accurate diagnosis or evidence-based treatment for bipolar disorder1,3

 
 

Patients with earlier onset of illness experience significantly longer duration of untreated bipolar disorder and may have poorer outcomes in adulthood3-5

 

Patients with earlier onset of illness experience significantly longer duration of untreated bipolar disorder and may have poorer outcomes in adulthood3-5

 
 

These delays have important consequences, including inadequate treatment, increased risk of suicide, increased rates of suicide, and poorer functional outcomes3,5,6

 

These delays have important consequences, including inadequate treatment, increased risk of suicide, increased rates of suicide, and poorer functional outcomes3,5,6

 

 


 

More time in a depressive state

Patients with bipolar disorder spend substantially more time in the depressive state

  • Symptoms of mania are often overlooked or unreported, leading to misdiagnosis of and treatment for unipolar depression 1,7
  • A diagnosis of unipolar depression should only be made after ruling out bipolar depression per current CANMAT/ISBD guideline8†

Line Graph Depicting a Patient's Experience of Mania, Depression, and Mixed Features

 


 

It may be bipolar depression

Clusters of symptoms and features may point to bipolar depression

About-BPD-Symptoms

Symptoms10-12

  • High trait or state of anxiety; agitation
  • Atypical depression
  • Psychomotor retardation
  • Psychotic features
About-BPD-Associated-Features

Associated features11

  • Work- and relationship-related stress
  • Comorbid substance use
About-BPD-Medical-History

Family and medical history12-14

  • Bipolar disorder in a first-degree relative
  • Antidepressant-induced mania or hypomania
  • Poor response to antidepressants
About-BPD-Illness-Course

Course of illness12-14

  • Early age of onset
  • Recurrent pattern of illness; abrupt onset and end of symptoms

Screening tools such as the MDQ and the CIDI 3.0 may be used to help uncover a history of mania to differentiate bipolar depression from unipolar depression in adults15,16

IMPACT OF BIPOLAR DEPRESSION

Increased rates of hospitalization and suicide attempts

For patients with bipolar disorder, suicide attempts, and hospitalization rates are high

  • The majority of suicide attempts occur during depressive episodes17
  • Suicide is one of the leading causes of death in patients with bipolar disorder8
  • Younger age of onset is associated with higher risk for suicide attempts18
  • Childhood onset is also associated with higher use of health services for depression as an adult (ie, hospitalization and ER visits)19

 

 


 

Prevalent comorbidities

Among patients with bipolar disorder, cardiovascular and metabolic comorbidities are prevalent

  • Endocrine and metabolic diseases, as well as high BMI, are also associated with poorer recovery from depressive episodes23
  • Consider metabolic profiles of all medications in patients with metabolic and weight issues8

Icon Depicting the Metabolic Comorbidities Prevalent in Patients with Bipolar Disorder

Icon Depicting the Metabolic Comorbidities Prevalent in Patients with Bipolar Disorder

 


 

A negative impact

Symptoms of bipolar depression have a negative impact on daily life

70% of patients with mild depressive symptoms still report significant problems:24  

About-BPD-Prevalent-with-Family

with family

About-BPD-Prevalent-at-Work-School

at work/school

About-BPD-Prevalent-at-Home

at home

About-BPD-Prevalent-with-Friends

with friends

  • Greater severity of depression is associated with more functional impairment and days of disability24,25
  • Divorce and separation are 2-3x higher then the general population26
  • Impairments in social and occupational functioning, as well as poorer quality of life, are greater during bipolar depression than manic or mixed symptoms 27-29
  • Cognitive impairments are more pronounced during depressive episodes than mood elevation29

Inventory for Depressive Symptomatology-Clinician Rated (IDS-C) total score between 13 and 27.

ABOUT BIPOLAR DEPRESSION


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References:

  1. Hirschfeld RM, Lewis L, Vornik LA. Perceptions and impact of bipolar disorder: how far have we really come? Results of the National Depressive and Manic-Depressive Association 2000 survey of individuals with bipolar disorder. J Clin Psychiatry. 2003;64(2):161-174.
  2. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Washington, DC: American Psychiatric Association; 2013.
  3. Drancourt N, Eta in B, Lajnef M, et al. Duration of untreated bipolar disorder: missed opportunities on the long road to optimal treatment. Acta Psychiatr Scand. 2013;127(2):136-144.
  4. Leverich GS, Post RM, Keck PE Jr, et al. The poor prognosis of childhood-onset bipolar disorder. J Pediatr. 2007;150(5):485-490.
  5. Post RM, Leverich GS, Kupka RW, et al. Early-onset bipolar disorder and treatment delay are risk factors for poor outcome in adulthood. J Clin Psychiatry. 2010;71(7):864-872.
  6. Goldberg JF, Ernst CL. Features associated with the delayed initiation of mood stabilizers at illness onset in bipolar disorder. J Clin Psychiatry. 2002;63(11):985-991.
  7. Muzina DJ, Colangelo E, Manning JS, Calabrese JR. Differentiating bipolar disorder from depression in primary care. Cleve Clin J Med. 2007;7 4(2):89,92,95-99.
  8. Yatham LN, Kennedy SH, Parikh SY, et al. Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder. Bipolar Disord. 20 l 8;20(2):1-74.
  9. Judd LL, Akiskal HS, Schettler PJ, et al. The long-term natural history of the weekly symptomatic status of bipolar I disorder. Arch Gen Psychiatry. 2002;59(6):530-537.
  10. Motovsky B, Pecenak J. Psychopathological characteristics of bipolar and unipolar depression-potential indicators of bipolarity.Psychiatr Danub. 2013;25(1) :34-39.
  11. Parker G, McCraw S, Hadzi-Pavlovic D, Hong M, Barrett M. Bipolar depression: prototypically melancholic in its clinical features. J Affect Disord. 2013; 147(1-3):331-337.
  12. Berk M, Berk L, Moss K, Dodd S, Malhi GS. Diagnosing bipolar disorder: how can we do it better? Med J Aust. 2006; 184(9):459-462.
  13. Galvao F, Sportiche S, Lambert J, et al. Clinical differences between unipolar and bipolar depression: interest of BDRS (Bipolar Depression Rating Scale). Compr Psychiatry. 2013;54(6):605-610.
  14. Perlis RH, Brown E, Baker RW, Nierenberg AA. Clinical features of bipolar depression versus major depressive disorder in large multicenter trials. Am J Psychiatry. 2006;163(2):225-231..
  15. Hirschfeld RM, Williams JB, Spitzer RL, et al. Development and validation of a screening instrument for bipolar spectrum disorder: the Mood Disorder Questionnaire. Am J Psychiatry. 2000;157(11): 1873-1875.
  16. Kessler RC, Ustiin TB. The World Mental Health (WMH) survey initiative version of the World Health Organization (WHO) Composite International Diagnostic Interview (CIDI). Int J Methods Psychiatr Res. 2004;13(2):93-121.
  17. Tondo L, Baldessarini RJ, Hennen J, Floris G, Silvetti F, Tohen M. Lithium treatment and risk of suicidal behavior in bipolar disorder patients. J Clin Psychiatry. 1998;59{8) :405-414.
  18. Perlis RH, Miyahara S, Marangell LB, et al; STEP-BD Investigators. Long-term implications of early onset in bipolar disorder: data from the first 1000 participants in the Systematic Treatment Enhancement Program for Bipolar Disorder {STEP-BD). Biol Psychiatry. 2004;55(9):875-881.
  19. Sala R, Goldstein Bl, Wang S, Florez-Salamanca L, lza M, Blanco C. Increased prospective health service use for depression among adults with childhood onset bipolar disorder. J Pediatr. 2013;163(5):1454-1457.
  20. Ruggero CJ, Chelminski I, Young D, Zimmerman M. Psychosocial impairment associated with bipolar II disorder. J Affect Disord. 2007; 104(1-3):53-60.
  21. Correll CU, Frederickson AM, Kane JM, Manu P. Equally increased risk for metabolic syndrome in patients with bipolar disorder and schizophrenia treated with second-generation anti psychotics. Bipolar Disord. 2008;10(7):788-797.
  22. Weiner M, Warren L, Fiedorowicz JG. Cardiovascular morbidity and mortality in bipolar disorder. Ann Clin Psychiatry. 2011;23 { 1 ):40-47.
  23. Kemp DE, Gao K, Chan P, Ganocy SJ, Findling RL, Calabrese JR. Medical comorbidity in bipolar disorder: relationship between illnesses of the endocrine/metabolic system and treatment outcome. Bipolar Disord. 2010;12(4):404-413.
  24. Altshuler LL, Post RM, Black DO, et al. Subsyndromal depressive symptoms are associated with functional impairment in patients with bipolar disorder: results of a large, multi site study. J Clin Psychiatry. 2006;67(10):1551-1560.
  25. Simon GE, Bauer MS, Ludman EJ, Operskalski BH, Uniitzer J. Mood symptoms, functional impairment, and disability in people with bipolar disorder: specific effects of mania and depression. J Clin Psychiatry. 2007;68(8):1237-1245.
  26. Kogan JN, Otto MW, Bauer MS, et al; for the STEP-BD Investigators. Demographic and diagnostic characteristics of the first 1000 patients enrolled in the Systematic Treatment Enhancement Program for Bipolar Disorder {STEP-BD). Bipolar Disord. 2004;6(6):460-469.
  27. Calabrese JR, Hirschfeld RM, Frye MA, Reed ML. Impact of depressive symptoms compared with manic symptoms in bipolar disorder: results of a U.S. community-based sample. J Clin Psychiatry. 2004;65(1l):1499-1504.
  28. Zhang H, Wisniewski SR, Bauer MS, Sachs GS, Those ME; for the STEP-BO Investigators. Comparisons of perceived quality of life across clinical states in bipolar disorder: data from the first 2000 Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BO) participants. Compr Psychiatry. 2006;47(3}:161-168.
  29. Rosa AR, Reinares M, Michalak EE, et al. Functional impairment and disability across mood states in bipolar disorder. Value Health. 2010;13(8):984-988.

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 behavior in pediatric and young adults in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors.

 

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 or may even arise after discontinuation of treatment. 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, or 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 Warning.