Patient portrayal. Individual results may vary.
Diagnostic Criteria & Patient Profile
Diagnostic criteria for major depressive disorder in adults15
Adapted from DSM-5®
To be diagnosed with MDD, a patient must have 5 or more of the following symptoms nearly every day* during the same 2‑week period and represent a change from previous functioning. At least 1 symptom must be either depressed mood or loss of interest/pleasure.
Patient may tell you about—and may show you—their symptoms.
1. Depressed mood most of the day
2. Loss of interest/pleasure in almost all activities most of the day
3. Significant change in weight or appetite
4. Insomnia or hypersomnia
5. Psychomotor agitation/retardation
6. Loss of energy or fatigue
7. Feelings of worthlessness or excessive or inappropriate guilt
8. Difficulty concentrating or indecisiveness
9. Recurrent suicidal thoughts or actions or recurrent thoughts of death
Do not include symptoms attributable to another medical condition.
- Symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of functioning
- Depressive episode is not attributable to the physiological effects of a substance or to another medical condition
- Depressive episode is not better explained by other psychotic, delusional, or other specified or unspecified schizophrenia spectrum disorders
- Patient has never had a manic or a hypomanic episode
Diagnosis should be based on a complete history and evaluation of the patient. View printable PHQ-9 screener.
*”Nearly every day” does not apply to symptom 3 (weight gain) and symptom 9.15
These are not the complete diagnostic criteria. DSM-5 is a registered trademark of the American Psychiatric Association.
Meet Sarah, 45 Married | Project manager | 2 active children
Sarah is struggling with multiple symptoms beyond sadness, including loss of interest, difficulty concentrating, low energy, and excessive guilt.
Patient’s concerns:
- Loss of interest in things she used to enjoy
- Struggles thinking and concentrating
- Low energy
Other considerations:
- Family and colleagues have noticed a change in behavior
- Determined to find a treatment plan that works for her
Not a complete list of symptoms. Having these symptoms does not necessarily mean a patient has MDD. Diagnosis should be based on full DSM-5® diagnostic criteria for MDD. Patients should be individually assessed for MDD with appropriate evaluation, management, and follow-up. Medication may not be appropriate for all patients with MDD. Individual results may vary.
DSM-5 is a registered trademark of the American Psychiatric Association.
Michele Novella, APRN‑BC
Fairfield University, Medical Director and Owner of Star Psychiatric Healthcare, LLC, Danbury, Connecticut
"When a patient comes to my practice experiencing symptoms of depression, an important part of my clinical evaluation will be to know the patient’s treatment history. As part of this, I make sure to ask my patients about any of their previous MDD treatments. In my clinical experience, MDD patients may need to try several treatments before finding the one that works for them, which might require follow‑up visits and calls. Knowing what the patient has tried and what they’re hoping to achieve allows me to make an informed treatment plan."
Michele Novella, APRN-BC, is the medical director and owner of Star Psychiatric Healthcare in Danbury, CT. She is a past member of Western Connecticut Health Network’s (WCHN) medical staff where she worked in the Behavioral Health Department including Crisis Intervention, Intensive Outpatient Program running groups and teaching Dialectical Behavioral Therapy (DBT). In the Outpatient setting, Michele held several critical incident debriefings following traumatic events and losses that were experienced by the staff there.
After graduating from Fairfield University, Michele worked as a Registered Nurse at Memorial Sloan-Kettering Cancer Center in New York City. Later, she worked at WCHN’s inpatient oncology unit before being asked to serve as Nurse Manager for the Outpatient Oncology & Chemotherapy Infusion Services at Associated Internists of Danbury. During that time, she received the prestigious American Cancer Society’s State‑Wide “Excellence in Oncology Nursing Award” in 1991.
Michele later pursued her Master’s Degree of Nursing from Yale University, graduating with Honors. She is Board Certified by the ANCC as both a Clinical Nurse Specialist in Adult Psychiatric Nursing, as well as a Psychiatric Nurse Practitioner.
She holds specialized training in DBT and cognitive behavioral therapy (CBT) and Critical Incident Stress Debriefing. She held a pivotal role in the aftermath of the Sandy Hook Shootings and helped to organize and run the crisis services offered to the public at Newtown’s Reed Intermediate School and treated several of the Newtown Police Department’s first responders. She has been asked to speak to several groups on post‑traumatic stress disorder and stress responses after trauma.
Ms Novella was paid as a consultant for Takeda and Lundbeck.
Jay Fawver, MD
Indiana University, Parkview Physicians Group Mind-Body Medicine, Fort Wayne, Indiana
"One important factor I consider when speaking with a patient with MDD is their social and occupational history. I use this information to discuss the symptoms of depression in terms the patient can better understand. I find this leads to more honest and productive conversations with patients."
Jay D. Fawver, MD, is the medical director at Parkview Mind-Body Medicine in Fort Wayne, IN. At Mind-Body Medicine, he orchestrates the treatment of over 8000 current patients in a shared pharmacological treatment model with 10 nurse practitioners assisted by nurses and medical assistants by utilizing customized electronic medical records to coordinate consistent clinical care with personalized and precision treatment strategies. His nurse practitioners provide integrated treatment by having access to direct consultation with Dr Fawver and the other nurse practitioners while utilizing treatment algorithms for various conditions and genetic profiles. Patients are monitored for treatment response and recovery utilizing patient-rated outcome metrics for mood, anxiety, cognition, insomnia, daily functioning, and side effects.
Since March 2020, Mind-Body Medicine has initiated telehealth for a majority of outpatients utilizing the new Epic Video Client internet platform. Utilizing this platform from their smartphones, tablets, or laptops, patients are prompted to complete outcome questionnaires on their MyChart portals 1 to 2 days prior to each appointment. These outcome metrics include the PHQ-9, GAD-7, Perceived Deficits Questionnaire (PDQ-20), Insomnia Severity Index (ISI), Work and Social Adjustment Scale (WSAS), and Patient Rated Inventory of Side Effects (PRISE), guiding treatment decisions and enhancing the efficiency of the outpatient video visit. Dr Fawver is a clinical professor of psychiatry at the Indiana University School of Medicine and is board certified by the American Board of Psychiatry and Neurology. He has been named a Distinguished Life Fellow of the American Psychiatric Association. A graduate of Purdue University School of Pharmacy, Dr Fawver was a pharmacist prior to his medical training. He has been an advisor to several pharmaceutical companies for over 30 years, participating as a principal investigator and assisting in the development of medication studies and outcomes of disease states such as depression, bipolar disorder, schizophrenia, and fibromyalgia with more recent work involving genetic correlations with medication treatment outcomes.
Since October 2019, Dr Fawver has been a certified Epic Physician Builder where he designs computer programs for charting in the electronic medical records based upon best practice guidelines.
Since 1997, he has been the host and producer of the Public Broadcasting System’s Matters of the Mind with Dr Jay Fawver, a weekly 30-minute live call-in television program addressing mental health topics.
Dr Fawver was paid as a consultant for Takeda and Lundbeck.
Michele Novella, APRN‑BC
Fairfield University, Medical Director and Owner of Star Psychiatric Healthcare, LLC, Danbury, Connecticut
"One symptom in particular that I find patients tend to misunderstand is anhedonia. For example, a patient may report that they are not experiencing pleasure in activities that they used to enjoy. Instead of identifying this as a symptom of depression, they may feel excessive guilt for this change, which is itself another symptom of MDD. I take this opportunity to remind my patients that, in people with MDD, these are symptoms of disease, not reflections of their character."
Michele Novella, APRN-BC, is the medical director and owner of Star Psychiatric Healthcare in Danbury, CT. She is a past member of Western Connecticut Health Network’s (WCHN) medical staff where she worked in the Behavioral Health Department including Crisis Intervention, Intensive Outpatient Program running groups and teaching Dialectical Behavioral Therapy (DBT). In the Outpatient setting, Michele held several critical incident debriefings following traumatic events and losses that were experienced by the staff there.
After graduating from Fairfield University, Michele worked as a Registered Nurse at Memorial Sloan-Kettering Cancer Center in New York City. Later, she worked at WCHN’s inpatient oncology unit before being asked to serve as Nurse Manager for the Outpatient Oncology & Chemotherapy Infusion Services at Associated Internists of Danbury. During that time, she received the prestigious American Cancer Society’s State-Wide “Excellence in Oncology Nursing Award” in 1991.
Michele later pursued her Master’s Degree of Nursing from Yale University, graduating with Honors. She is Board Certified by the ANCC as both a Clinical Nurse Specialist in Adult Psychiatric Nursing, as well as a Psychiatric Nurse Practitioner.
She holds specialized training in DBT and cognitive behavioral therapy (CBT) and Critical Incident Stress Debriefing. She held a pivotal role in the aftermath of the Sandy Hook Shootings and helped to organize and run the crisis services offered to the public at Newtown’s Reed Intermediate School and treated several of the Newtown Police Department’s first responders. She has been asked to speak to several groups on post‑traumatic stress disorder and stress responses after trauma.
Ms Novella was paid as a consultant for Takeda and Lundbeck.
Gregory Mattingly, MD
Washington University, Midwest Research Group, St. Charles, Missouri
"When a provider puts the symptoms of depression in the context of the patient's life, we keep the conversation centered on how MDD affects them every day."
Dr Mattingly is a physician and principal investigator in clinical trials for Midwest Research Group. He is also a founding partner of St. Charles Psychiatric Associates, where he treats adults, adolescents, and children with ADHD. Dr Greg Mattingly is board-certified in adult and adolescent psychiatry and has been a principal investigator in over 300 clinical trials focusing on ADHD and related conditions.
Having served on numerous national and international advisory panels, Dr Mattingly has received awards and distinctions for clinical leadership and neuroscience research. He currently serves on the board of directors for the American Professional Society of ADHD and Related Disorders (APSARD).
Dr Mattingly was paid as a consultant for Takeda and Lundbeck.
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Safety profile
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IMPORTANT SAFETY INFORMATION
WARNING: SUICIDAL THOUGHTS & BEHAVIORS
- Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies.
- Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors.
- TRINTELLIX is not approved for use in pediatric patients.
CONTRAINDICATIONS
- Hypersensitivity: Hypersensitivity to vortioxetine or any component of the TRINTELLIX formulation. Hypersensitivity reactions including anaphylaxis, angioedema, and urticaria have been reported in patients treated with TRINTELLIX.
- Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to treat psychiatric disorders with TRINTELLIX or within 21 days of stopping treatment with TRINTELLIX, due to an increased risk of serotonin syndrome. Do not use TRINTELLIX within 14 days of stopping an MAOI intended to treat psychiatric disorders.
- Linezolid and Methylene Blue: Do not start TRINTELLIX in a patient being treated with MAOIs such as linezolid or intravenous methylene blue, due to an increased risk of serotonin syndrome.
WARNINGS AND PRECAUTIONS
- Suicidal Thoughts and Behaviors in Adolescents and Young Adults: Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing TRINTELLIX, in patients whose depression is persistently worse, or who are experiencing emergence of suicidal thoughts and behaviors. In pooled analyses of placebo-controlled trials of antidepressants, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients ages 24 and younger was greater than in placebo-treated patients.
- Serotonin Syndrome: Serotonergic antidepressants, including TRINTELLIX, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, meperidine, methadone, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs. Serotonin syndrome signs and symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Monitor all patients taking TRINTELLIX for the emergence of serotonin syndrome. Discontinue treatment with TRINTELLIX and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of TRINTELLIX with other serotonergic drugs is clinically warranted, inform patients of the increased risk for serotonin syndrome and monitor for symptoms.
- Increased Risk of Bleeding: The use of drugs that interfere with serotonin reuptake inhibition, including TRINTELLIX, may increase the risk of bleeding events, including but not limited to gastrointestinal. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, and other anticoagulants may add to this risk. Inform patients about the increased risk of bleeding when TRINTELLIX is coadministered with NSAIDs, aspirin, or other drugs that affect coagulation or bleeding. Exposure to SSRIs or SNRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage.
- Activation of Mania/Hypomania: In patients with bipolar disorder, treating a depressive episode with TRINTELLIX or another antidepressant may precipitate a mixed/manic episode. Prior to initiating treatment with TRINTELLIX, screen patients for any personal or family history of bipolar disorder, mania, or hypomania.
- Discontinuation Syndrome: Adverse reactions have been reported upon abrupt discontinuation of treatment with TRINTELLIX at doses of 15 mg/day and 20 mg/day. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible.
- 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 treatment with serotonergic drugs, including TRINTELLIX, 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. Symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which can lead to falls. More severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death. Discontinue TRINTELLIX in patients with symptomatic hyponatremia and institute appropriate medical intervention.
- Sexual Dysfunction: Use of serotonergic antidepressants, including TRINTELLIX, may cause symptoms of sexual dysfunction. In male patients, serotonergic antidepressant use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, use may result in decreased libido and delayed or absent orgasm.
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: nausea, constipation, and vomiting.
DRUG INTERACTIONS
Concomitant administration of TRINTELLIX and strong CYP2D6 inhibitors or strong CYP inducers may require a dose adjustment of TRINTELLIX.
PREGNANCY
Exposure to serotonergic antidepressants, including TRINTELLIX, in late pregnancy may increase the risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN). Monitor neonates who were exposed to TRINTELLIX in the third trimester for PPHN and drug discontinuation syndrome. Use of TRINTELLIX in the month before delivery may be associated with an increased risk of postpartum hemorrhage.
INDICATION
TRINTELLIX is indicated for the treatment of Major Depressive Disorder (MDD) in adults.
Please click for Full Prescribing Information.
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at
IMPORTANT SAFETY INFORMATION
WARNING: SUICIDAL THOUGHTS & BEHAVIORS
- Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies.
- Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors.
- TRINTELLIX is not approved for use in pediatric patients.
CONTRAINDICATIONS
- Hypersensitivity: Hypersensitivity to vortioxetine or any component of the TRINTELLIX formulation. Hypersensitivity reactions including anaphylaxis, angioedema, and urticaria have been reported in patients treated with TRINTELLIX.
- Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to treat psychiatric disorders with TRINTELLIX or within 21 days of stopping treatment with TRINTELLIX, due to an increased risk of serotonin syndrome. Do not use TRINTELLIX within 14 days of stopping an MAOI intended to treat psychiatric disorders.
- Linezolid and Methylene Blue: Do not start TRINTELLIX in a patient being treated with MAOIs such as linezolid or intravenous methylene blue, due to an increased risk of serotonin syndrome.
WARNINGS AND PRECAUTIONS
- Suicidal Thoughts and Behaviors in Adolescents and Young Adults: Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing TRINTELLIX, in patients whose depression is persistently worse, or who are experiencing emergence of suicidal thoughts and behaviors. In pooled analyses of placebo-controlled trials of antidepressants, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients ages 24 and younger was greater than in placebo-treated patients.
- Serotonin Syndrome: Serotonergic antidepressants, including TRINTELLIX, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, meperidine, methadone, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs. Serotonin syndrome signs and symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Monitor all patients taking TRINTELLIX for the emergence of serotonin syndrome. Discontinue treatment with TRINTELLIX and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of TRINTELLIX with other serotonergic drugs is clinically warranted, inform patients of the increased risk for serotonin syndrome and monitor for symptoms.
- Increased Risk of Bleeding: The use of drugs that interfere with serotonin reuptake inhibition, including TRINTELLIX, may increase the risk of bleeding events, including but not limited to gastrointestinal. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, and other anticoagulants may add to this risk. Inform patients about the increased risk of bleeding when TRINTELLIX is coadministered with NSAIDs, aspirin, or other drugs that affect coagulation or bleeding. Exposure to SSRIs or SNRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage.
- Activation of Mania/Hypomania: In patients with bipolar disorder, treating a depressive episode with TRINTELLIX or another antidepressant may precipitate a mixed/manic episode. Prior to initiating treatment with TRINTELLIX, screen patients for any personal or family history of bipolar disorder, mania, or hypomania.
- Discontinuation Syndrome: Adverse reactions have been reported upon abrupt discontinuation of treatment with TRINTELLIX at doses of 15 mg/day and 20 mg/day. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible.
- 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 treatment with serotonergic drugs, including TRINTELLIX, 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. Symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which can lead to falls. More severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death. Discontinue TRINTELLIX in patients with symptomatic hyponatremia and institute appropriate medical intervention.
- Sexual Dysfunction: Use of serotonergic antidepressants, including TRINTELLIX, may cause symptoms of sexual dysfunction. In male patients, serotonergic antidepressant use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, use may result in decreased libido and delayed or absent orgasm.
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: nausea, constipation, and vomiting.
DRUG INTERACTIONS
Concomitant administration of TRINTELLIX and strong CYP2D6 inhibitors or strong CYP inducers may require a dose adjustment of TRINTELLIX.
PREGNANCY
Exposure to serotonergic antidepressants, including TRINTELLIX, in late pregnancy may increase the risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN). Monitor neonates who were exposed to TRINTELLIX in the third trimester for PPHN and drug discontinuation syndrome. Use of TRINTELLIX in the month before delivery may be associated with an increased risk of postpartum hemorrhage.
INDICATION
TRINTELLIX is indicated for the treatment of Major Depressive Disorder (MDD) in adults.
Please click for Full Prescribing Information.
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at
US-VOR-0993v1.0 10/23
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WARNING: SUICIDAL THOUGHTS & BEHAVIORS
- Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies.
- Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors.
- TRINTELLIX is not approved for use in pediatric patients.
CONTRAINDICATIONS
- Hypersensitivity: Hypersensitivity to vortioxetine or any component of the TRINTELLIX formulation. Hypersensitivity reactions including anaphylaxis, angioedema, and urticaria have been reported in patients treated with TRINTELLIX.
- Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to treat psychiatric disorders with TRINTELLIX or within 21 days of stopping treatment with TRINTELLIX, due to an increased risk of serotonin syndrome. Do not use TRINTELLIX within 14 days of stopping an MAOI intended to treat psychiatric disorders.
- Linezolid and Methylene Blue: Do not start TRINTELLIX in a patient being treated with MAOIs such as linezolid or intravenous methylene blue, due to an increased risk of serotonin syndrome.
WARNINGS AND PRECAUTIONS
- Suicidal Thoughts and Behaviors in Adolescents and Young Adults: Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing TRINTELLIX, in patients whose depression is persistently worse, or who are experiencing emergence of suicidal thoughts and behaviors. In pooled analyses of placebo-controlled trials of antidepressants, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients ages 24 and younger was greater than in placebo-treated patients.
- Serotonin Syndrome: Serotonergic antidepressants, including TRINTELLIX, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, meperidine, methadone, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs. Serotonin syndrome signs and symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Monitor all patients taking TRINTELLIX for the emergence of serotonin syndrome. Discontinue treatment with TRINTELLIX and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of TRINTELLIX with other serotonergic drugs is clinically warranted, inform patients of the increased risk for serotonin syndrome and monitor for symptoms.
- Increased Risk of Bleeding: The use of drugs that interfere with serotonin reuptake inhibition, including TRINTELLIX, may increase the risk of bleeding events, including but not limited to gastrointestinal. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, and other anticoagulants may add to this risk. Inform patients about the increased risk of bleeding when TRINTELLIX is coadministered with NSAIDs, aspirin, or other drugs that affect coagulation or bleeding. Exposure to SSRIs or SNRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage.
- Activation of Mania/Hypomania: In patients with bipolar disorder, treating a depressive episode with TRINTELLIX or another antidepressant may precipitate a mixed/manic episode. Prior to initiating treatment with TRINTELLIX, screen patients for any personal or family history of bipolar disorder, mania, or hypomania.
- Discontinuation Syndrome: Adverse reactions have been reported upon abrupt discontinuation of treatment with TRINTELLIX at doses of 15 mg/day and 20 mg/day. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible.
- 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 treatment with serotonergic drugs, including TRINTELLIX, 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. Symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which can lead to falls. More severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death. Discontinue TRINTELLIX in patients with symptomatic hyponatremia and institute appropriate medical intervention.
- Sexual Dysfunction: Use of serotonergic antidepressants, including TRINTELLIX, may cause symptoms of sexual dysfunction. In male patients, serotonergic antidepressant use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, use may result in decreased libido and delayed or absent orgasm.
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: nausea, constipation, and vomiting.
DRUG INTERACTIONS
Concomitant administration of TRINTELLIX and strong CYP2D6 inhibitors or strong CYP inducers may require a dose adjustment of TRINTELLIX.
PREGNANCY
Exposure to serotonergic antidepressants, including TRINTELLIX, in late pregnancy may increase the risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN). Monitor neonates who were exposed to TRINTELLIX in the third trimester for PPHN and drug discontinuation syndrome. Use of TRINTELLIX in the month before delivery may be associated with an increased risk of postpartum hemorrhage.
INDICATION
TRINTELLIX is indicated for the treatment of Major Depressive Disorder (MDD) in adults.
Please click for Full Prescribing Information.
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at