A nurse practitioner’s perspective on working with patients who have major depressive disorder

Indication:
Trintellix is indicated for the treatment of major depressive disorder (MDD) in adults.

Individual results may vary.

Angie Golden, DNP, FNP-C, FAANP, discusses the unique aspects of her role in the treatment of patients with major depressive disorder.

Nurse practitioner Angie Golden

Featuring Angie Golden, DNP, FNP-C, FAANP

Angie Golden, DNP, FNP-C, FAANP, is a family nurse practitioner in Munds Park, Arizona, where she runs her own practice and also works with patients at a local community health center. In her 17 years as a nurse practitioner, Dr. Golden has seen numerous patients make an appointment for symptoms such as low mood or insomnia, not realizing those could be signs of major depressive disorder (MDD). Because MDD involves a constellation of symptoms, Dr. Golden indicates that her patients may not always understand the many different ways it can affect them.10 That’s why she believes being an educator is so critical to her role as a nurse practitioner, and she carefully teaches her patients about each facet of the disorder as a part of her approach to treatment.

Establishing a Dialogue

Many different conditions can be responsible for a symptom such as low mood, so it can take a good deal of investigation to determine if MDD might be the cause.10 “The dialogue really starts with a good history,” says Dr. Golden. A dialogue-driven and evaluative approach helps her better recognize some of the subtleties of MDD and accurately diagnose her patients. Asking patients extensive questions about how they’re feeling and what symptoms they’re having, as well as using screening tools such as the Patient Health Questionnaire (PHQ) and Montgomery-Åsberg Depression Rating Scale (MADRS) tests help to further guide the conversation.13

“A dialogue-driven and evaluative approach helps better recognize some of the subtleties of MDD and accurately diagnose patients.”

Discussing MDD

The next step of the discussion, according to Dr. Golden, is to help the patient understand what major depressive disorder encompasses. “People have a preconceived notion that it’s all in their heads,” she says. Getting patients to let go of that notion begins with helping them understand the pathophysiology of the disease. “I want them to know what the neurochemicals are and talk about it as a disease process. I have a model of a brain and I go over all the neurochemicals and talk about what happens in the brain, how those chemicals get out of balance in major depressive disorder. This is how I approach diagnosis for my patients.”11

One of the biggest challenges when discussing MDD with patients can be communicating the extent of the symptoms. “I’ll sit down and talk through all the symptoms a patient is experiencing—that it’s a lot more than low mood. It might also be insomnia, trouble concentrating, increased appetite with weight gain, or a loss of pleasure in activities they once enjoyed. And we start to build that picture,” Dr. Golden says. Most of the time, patients come to her wanting relief for physical symptoms, not realizing that emotional and cognitive symptoms are also part of the disease process—and that all 3 can present themselves as a constellation.10

Addressing Treatment and Side Effects

When starting patients on medication, Dr. Golden recognizes the possibility of side effects.10,12 To address this, she conducts a series of follow-up appointments to discuss the nature of potential side effects.

During these appointments, she discusses what side effects patients can expect and which to report to her right away. “We do 72-hour phone follow-ups with every new medication,” she says. “I always make sure that they have a family member at home that they are willing to let me talk to and discuss what side effects to monitor for. If they don’t have a family member, then the patient and I are going to be in even closer contact to make sure that they don’t develop suicidal ideation or are having side effects they’re not talking about. Then, we do a follow-up at the office after 2 weeks.”

Treating Elderly Patients

Major depressive disorder can affect patients of any age, but Dr. Golden has special considerations when it affects older patients.10,12 “I like to consider several factors when treating elderly patients, including a treatment’s safety and efficacy data in that population, pharmacokinetic profile, age-specific dose adjustments, and any other relevant safety considerations,” she says. Dr. Golden also proactively screens all of her elderly patients for MDD, whether they’re complaining of all the potential symptoms or not.

When it comes time to choose a medication for elderly patients diagnosed with MDD, Dr. Golden pays special attention to each potential treatment option’s safety and tolerability profile in the elderly population. The information available on Trintellix made it a potential choice for her appropriate patients with MDD. “Trintellix has been evaluated for safety in 4,746 patients aged 18–88 years in clinical studies.1 Also, one of the 6–8 week clinical studies with Trintellix was a dedicated study in the elderly (64–88 years) looking at change from baseline in HAM-D24 vs placebo. That’s partially why I consider Trintellix when I am treating my geriatric patients.”

“If our peers understand MDD better, including the constellation of physical, emotional, and cognitive symptoms, and the neurochemistry, it really helps us support patients and get them to understand how important it is to get treatment.”10,11

As the number of nurse practitioners grows and more become prescribers of treatments for MDD, Dr. Golden feels that their perspective will have a greater impact in overall treatment.14 “Nurses are great educators. One of our greatest strengths is our ability to educate our patients.” Dr. Golden thinks nurse practitioners can use their perspective to help improve overall patient-clinician communication and ultimately help a greater number of patients with MDD.10,11 “If our peers understand MDD better, including the constellation of physical, emotional, and cognitive symptoms, and the neurochemistry, it really helps us support patients and get them to understand how important it is to get treatment.”

Important Safety Information for TRINTELLIX (vortioxetine)

Warning: Suicidal Thoughts and Behaviors

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a trend toward reduced risk with antidepressant use in patients aged 65 and older.

Warning: Suicidal Thoughts and Behaviors

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a trend toward reduced risk with antidepressant use in patients aged 65 and older.

In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber.

TRINTELLIX has not been evaluated for use in pediatric patients.

CONTRAINDICATIONS

Hypersensitivity: Hypersensitivity to vortioxetine or any components of the TRINTELLIX formulation. Angioedema has been reported in patients treated with TRINTELLIX.

Monoamine Oxidase Inhibitors (MAOIs): Due to an increased risk of serotonin syndrome, do not use MAOIs intended to treat psychiatric disorders with TRINTELLIX or within 21 days of stopping treatment with TRINTELLIX. Do not use TRINTELLIX within 14 days of stopping an MAOI intended to treat psychiatric disorders. Do not start TRINTELLIX in a patient who is being treated with linezolid or intravenous methylene blue.

Warnings and Precautions

Clinical Worsening and Suicide Risk: All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality (anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania), especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Families and caregivers of patients being treated with antidepressants for MDD or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients daily.

Serotonin Syndrome: The development of a potentially life-threatening serotonin syndrome has been reported with serotonergic antidepressants (SNRIs, SSRIs, and others), including TRINTELLIX, when used alone but more often when used concomitantly with other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort), and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Serotonin syndrome symptoms may include mental status changes (eg, agitation, hallucinations, delirium, and coma), autonomic instability (eg, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (eg, tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea). If such symptoms occur, discontinue TRINTELLIX and any concomitant serotonergic agents, and initiate supportive symptomatic treatment. If concomitant use of TRINTELLIX is clinically warranted, patients should be made aware of and monitored for potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.

Abnormal Bleeding: Treatment with serotonergic antidepressants (SSRIs, SNRIs, and others) may increase the risk of abnormal bleeding. Patients should be cautioned about the increased risk of bleeding when TRINTELLIX is coadministered with NSAIDs, aspirin, or other drugs that affect coagulation.

Activation of Mania/Hypomania: Activation of mania/hypomania can occur with antidepressant treatment. Prior to initiating treatment with an antidepressant, screen patients for bipolar disorder. As with all antidepressants, use TRINTELLIX cautiously in patients with a history or family history of bipolar disorder, mania, or hypomania.

Angle-Closure Glaucoma: The pupillary dilation that occurs following use of many antidepressant drugs, including TRINTELLIX, may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

Hyponatremia: Hyponatremia has occurred as a result of serotonergic drugs and in many cases, appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). Elderly patients and patients taking diuretics or who are otherwise volume-depleted can be at greater risk. More severe or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death. Discontinue TRINTELLIX in patients with symptomatic hyponatremia and initiate appropriate medical intervention.

Adverse Reactions: The most commonly observed adverse reactions for TRINTELLIX in 6- to 8-week placebo-controlled studies (incidence ≥5% and at least twice the rate of placebo) were by dose (5 mg, 10 mg, 15 mg, 20 mg) vs placebo: nausea (21%, 26%, 32%, 32% vs 9%), constipation (3%, 5%, 6%, 6% vs 3%), and vomiting (3%, 5%, 6%, 6% vs 1%).

Drug Interactions: Concomitant administration of TRINTELLIX and strong CYP2D6 inhibitors or strong CYP inducers may require a dose adjustment of TRINTELLIX.

Indication

TRINTELLIX is indicated for the treatment of major depressive disorder in adults.

Please see Full Prescribing Information and Medication Guide for TRINTELLIX.

  1. Trintellix (vortioxetine) prescribing information. Takeda Pharmaceuticals.
  2. Alvarez E, Perez V, Dragheim M, et al. A double-blind, randomized, placebo-controlled, active reference study of Lu AA21004 in patients with major depressive disorder. Int J Neuropsychopharmacol. 2012;15(5):589-600.
  3. Henigsberg N, Mahableshwarkar AR, Jacobsen P, et al. A randomized, double-blind, placebo-controlled 8-week trial of the efficacy and tolerability of multiple doses of Lu AA21004 in adults with major depressive disorder. J Clin Psychiatry. 2012;73(7):953-959.
  4. Boulenger J-P, Loft H, Olsen CK. Efficacy and safety of vortioxetine (Lu AA21004), 15 and 20 mg/day: a randomized, double-blind, placebo-controlled, duloxetine-referenced study in the acute treatment of adult patients with major depressive disorder. Int Clin Psychopharmacol. 2014;29(3):138-149.
  5. Mahableshwarkar AR, Jacobsen PL, Chen Y, et al. A randomized, double-blind, duloxetine-referenced study comparing efficacy and tolerability of 2 fixed doses of vortioxetine in the acute treatment of adults with MDD. Psychopharmacology (Berl). 2015;232(12):2061-2070.
  6. Jacobsen PL, Mahableshwarkar AR, Serenko M, et al. A randomized, double-blind, placebo-controlled study of the efficacy and safety of vortioxetine 10 mg and 20 mg in adults with major depressive disorder. J Clin Psychiatry. 2015;76(5):575-582.
  7. Katona C, Hansen T, Olsen CK. A randomized, double-blind, placebo-controlled, duloxetine-referenced, fixed-dose study comparing the efficacy and safety of Lu AA21004 in elderly patients with major depressive disorder. Int Clin Psychopharmacol. 2012;27(4):215-223.
  8. Boulenger J-P, Loft H, Florea I. A randomized clinical study of Lu AA21004 in the prevention of relapse in patients with major depressive disorder. J Psychopharmacol. 2012;26(11):1408-1416.
  9. Data on file. Takeda Pharmaceuticals.
  10. American Psychiatric Association. Depressive disorders. In: Diagnostic and Statistical Manual of Mental Disorders: DSM-5. 5th ed. Arlington, VA: American Psychiatric Association; 2013:155-188.
  11. Werner F, Coveñas R. Classical neurotransmitters and neuropeptides involved in major depression in a multi-neurotransmitter system: a focus on antidepressant drugs. Curr Med Chem. 2013;20(38):4853-4858.
  12. Gelenberg AJ, Freeman MP, Markowitz JC, et al, for the Work Group on Major Depressive Disorder. Practice Guideline for the Treatment of Patients with Major Depressive Disorder. 3rd ed. Arlington, VA: American Psychiatric Publishing; 2010.
  13. Conradi HJ, Ormel J, de Jonge P. Presence of individual (residual) symptoms during depressive episodes and period of remission: a 3-year prospective study. Psychol Med. 2011;41(6):1165-1174.
  14. Gualtieri CT, Morgan DW. The frequency of cognitive impairment in patients with anxiety, depression, and bipolar disorder: an unaccounted source of variance in clinical trials. J Clin Psychiatry. 2008;69(7):1122-1130.

Important Safety Information for TRINTELLIX (vortioxetine)

Warning: Suicidal Thoughts and Behaviors

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a trend toward reduced risk with antidepressant use in patients aged 65 and older.

Warning: Suicidal Thoughts and Behaviors

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a trend toward reduced risk with antidepressant use in patients aged 65 and older.

In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber.

TRINTELLIX has not been evaluated for use in pediatric patients.

CONTRAINDICATIONS

Hypersensitivity: Hypersensitivity to vortioxetine or any components of the TRINTELLIX formulation. Angioedema has been reported in patients treated with TRINTELLIX.

Monoamine Oxidase Inhibitors (MAOIs): Due to an increased risk of serotonin syndrome, do not use MAOIs intended to treat psychiatric disorders with TRINTELLIX or within 21 days of stopping treatment with TRINTELLIX. Do not use TRINTELLIX within 14 days of stopping an MAOI intended to treat psychiatric disorders. Do not start TRINTELLIX in a patient who is being treated with linezolid or intravenous methylene blue.

Warnings and Precautions

Clinical Worsening and Suicide Risk: All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality (anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania), especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Families and caregivers of patients being treated with antidepressants for MDD or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients daily.

Serotonin Syndrome: The development of a potentially life-threatening serotonin syndrome has been reported with serotonergic antidepressants (SNRIs, SSRIs, and others), including TRINTELLIX, when used alone but more often when used concomitantly with other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort), and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Serotonin syndrome symptoms may include mental status changes (eg, agitation, hallucinations, delirium, and coma), autonomic instability (eg, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (eg, tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea). If such symptoms occur, discontinue TRINTELLIX and any concomitant serotonergic agents, and initiate supportive symptomatic treatment. If concomitant use of TRINTELLIX is clinically warranted, patients should be made aware of and monitored for potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.

Abnormal Bleeding: Treatment with serotonergic antidepressants (SSRIs, SNRIs, and others) may increase the risk of abnormal bleeding. Patients should be cautioned about the increased risk of bleeding when TRINTELLIX is coadministered with NSAIDs, aspirin, or other drugs that affect coagulation.

Activation of Mania/Hypomania: Activation of mania/hypomania can occur with antidepressant treatment. Prior to initiating treatment with an antidepressant, screen patients for bipolar disorder. As with all antidepressants, use TRINTELLIX cautiously in patients with a history or family history of bipolar disorder, mania, or hypomania.

Angle-Closure Glaucoma: The pupillary dilation that occurs following use of many antidepressant drugs, including TRINTELLIX, may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

Hyponatremia: Hyponatremia has occurred as a result of serotonergic drugs and in many cases, appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). Elderly patients and patients taking diuretics or who are otherwise volume-depleted can be at greater risk. More severe or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death. Discontinue TRINTELLIX in patients with symptomatic hyponatremia and initiate appropriate medical intervention.

Adverse Reactions: The most commonly observed adverse reactions for TRINTELLIX in 6- to 8-week placebo-controlled studies (incidence ≥5% and at least twice the rate of placebo) were by dose (5 mg, 10 mg, 15 mg, 20 mg) vs placebo: nausea (21%, 26%, 32%, 32% vs 9%), constipation (3%, 5%, 6%, 6% vs 3%), and vomiting (3%, 5%, 6%, 6% vs 1%).

Drug Interactions: Concomitant administration of TRINTELLIX and strong CYP2D6 inhibitors or strong CYP inducers may require a dose adjustment of TRINTELLIX.

Indication

TRINTELLIX is indicated for the treatment of major depressive disorder in adults.

Please see Full Prescribing Information and Medication Guide for TRINTELLIX.

  1. Trintellix (vortioxetine) prescribing information. Takeda Pharmaceuticals.
  2. Alvarez E, Perez V, Dragheim M, et al. A double-blind, randomized, placebo-controlled, active reference study of Lu AA21004 in patients with major depressive disorder. Int J Neuropsychopharmacol. 2012;15(5):589-600.
  3. Henigsberg N, Mahableshwarkar AR, Jacobsen P, et al. A randomized, double-blind, placebo-controlled 8-week trial of the efficacy and tolerability of multiple doses of Lu AA21004 in adults with major depressive disorder. J Clin Psychiatry. 2012;73(7):953-959.
  4. Boulenger J-P, Loft H, Olsen CK. Efficacy and safety of vortioxetine (Lu AA21004), 15 and 20 mg/day: a randomized, double-blind, placebo-controlled, duloxetine-referenced study in the acute treatment of adult patients with major depressive disorder. Int Clin Psychopharmacol. 2014;29(3):138-149.
  5. Mahableshwarkar AR, Jacobsen PL, Chen Y, et al. A randomized, double-blind, duloxetine-referenced study comparing efficacy and tolerability of 2 fixed doses of vortioxetine in the acute treatment of adults with MDD. Psychopharmacology (Berl). 2015;232(12):2061-2070.
  6. Jacobsen PL, Mahableshwarkar AR, Serenko M, et al. A randomized, double-blind, placebo-controlled study of the efficacy and safety of vortioxetine 10 mg and 20 mg in adults with major depressive disorder. J Clin Psychiatry. 2015;76(5):575-582.
  7. Katona C, Hansen T, Olsen CK. A randomized, double-blind, placebo-controlled, duloxetine-referenced, fixed-dose study comparing the efficacy and safety of Lu AA21004 in elderly patients with major depressive disorder. Int Clin Psychopharmacol. 2012;27(4):215-223.
  8. Boulenger J-P, Loft H, Florea I. A randomized clinical study of Lu AA21004 in the prevention of relapse in patients with major depressive disorder. J Psychopharmacol. 2012;26(11):1408-1416.
  9. Data on file. Takeda Pharmaceuticals.
  10. American Psychiatric Association. Depressive disorders. In: Diagnostic and Statistical Manual of Mental Disorders: DSM-5. 5th ed. Arlington, VA: American Psychiatric Association; 2013:155-188.
  11. Werner F, Coveñas R. Classical neurotransmitters and neuropeptides involved in major depression in a multi-neurotransmitter system: a focus on antidepressant drugs. Curr Med Chem. 2013;20(38):4853-4858.
  12. Gelenberg AJ, Freeman MP, Markowitz JC, et al, for the Work Group on Major Depressive Disorder. Practice Guideline for the Treatment of Patients with Major Depressive Disorder. 3rd ed. Arlington, VA: American Psychiatric Publishing; 2010.
  13. Conradi HJ, Ormel J, de Jonge P. Presence of individual (residual) symptoms during depressive episodes and period of remission: a 3-year prospective study. Psychol Med. 2011;41(6):1165-1174.
  14. Gualtieri CT, Morgan DW. The frequency of cognitive impairment in patients with anxiety, depression, and bipolar disorder: an unaccounted source of variance in clinical trials. J Clin Psychiatry. 2008;69(7):1122-1130.