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Paid content from Takeda Pharmaceuticals
Understanding Speed of Processing in MDD: Insights on DSST Data and a Treatment Option
Paid content from Takeda Pharmaceuticals
Please click for Full Prescribing Information
Hello, I’m Dr. Leslie Citrome, Clinical Professor of Psychiatry and Behavioral Sciences at New York Medical College in Valhalla, New York. In this second video which is sponsored content from Takeda Pharmaceuticals, I’ll provide insights on an aspect of cognitive function that may be impaired by MDD —specifically something that we call speed of processing.1 Speed of processing refers to the pace with which one can accurately process information or the time needed to complete a mental task.2
As a practicing psychiatrist, I’ve spent a lot of time delving into the complexities of treating MDD. Through my experience with patients, I’ve discussed several different treatment options, including Trintellix®, also known as vortioxetine, a prescription medication indicated to treat MDD in adults. Trintellix is available as 5 mg, 10 mg, and 20 mg tablets.1
TRINTELLIX has a Boxed Warning for suicidal thoughts and 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.
Please listen for additional Important Safety Information later in this video, and see the Full Prescribing Information by clicking on the link in the transcript below this video.
Trintellix monotherapy was shown to reduce the overall symptoms of MDD across 6 short-term clinical studies, which was measured by the total score of the Hamilton Depression 24-item Rating Scale or the Montgomery-Asberg Depression Rating Scale.1 Those six clinical studies were randomized, double-blind, and placebo-controlled, over a 6- to 8-week duration. Patients were given a once-daily dosage of Trintellix, ranging from 5 mg to 20 mg.
The most common adverse reactions with an incidence of 5% or more and at least twice the rate of placebo in the 6- to 8-week studies were nausea, constipation, and vomiting.
In addition to the efficacy demonstrated in the six, short-term studies, Trintellix has been shown to improve speed of processing as measured by the Digit Symbol Substitution Test, or DSST in patients with MDD.1
The DSST is a neuropsychological test that most specifically measures processing speed, which is an aspect of cognitive function that may be impaired in MDD.1 Although the DSST is simple to use, it is not generally employed in my routine clinical practice. However, I believe it is useful in clinical research in order to objectively measure this important component of cognitive functioning.
Trintellix's speed of processing data draw from two 8-week studies, numbered Study 7 and Study 8 in the product label. Both studies were randomized, double-blind, placebo-controlled, and assessed the effect of Trintellix on the number of correct responses on the DSST in patients aged 18-65 being treated for acute MDD.1,3,4 Patients in the Trintellix arm in Study 7 received Trintellix 10 mg/day or 20 mg/day, while patients in Study 8 received a flexible dose of Trintellix 10 mg or 20 mg daily. Study 7 randomized adult patients meeting the diagnostic criteria for recurrent MDD and Study 8 randomized adult patients meeting the diagnostic criteria for recurrent MDD and reporting subjective difficulty concentrating or slow thinking. Neither study included patients whose MDD was in remission, yet still continued to experience difficulty concentrating or slow thinking.1
Trintellix doses were statistically superior to placebo in improvement in the number of correct responses on the DSST, with observed P values less than 0.001 and 0.05 for Study 7 and Study 8, respectively.1,3,4,6 [However,] the effects observed on DSST may reflect a general improvement in depression.1 Trintellix is the only antidepressant that has data on speed of processing during the treatment of MDD in its U.S. Prescribing Information.5 Comparative studies have not been conducted to demonstrate a therapeutic advantage for Trintellix over other antidepressants on the DSST.1
Common adverse events, or AEs, as defined by an incidence greater than or equal to 5% for Trintellix in Study 7 were nausea and headache.3
Common AEs with an incidence greater than or equal to 5% for Trintellix in Study 8 were nausea, headache, and diarrhea.4
In one study two serious AEs were reported in the Trintellix group, and in the other study, one patient taking Trintellix attempted suicide.
Trintellix is contraindicated to patients with hypersensitivity to vortioxetine or any component of the Trintellix formulation.1 Hypersensitivity reactions including anaphylaxis, angioedema, and urticaria have been reported in patients treated with Trintellix. Additionally, do not use Monoamine Oxidase Inhibitors or 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, and 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.1
Remember, speed of processing is an aspect of cognitive function that may be impacted in patients with MDD.
I encourage you to visit www.TrintellixHCP.com for more expert insights. The site also includes information about how your eligible patients can enroll in the Trintellix Savings Program.
Thank you for tuning in to this Expert Perspective series. We hope you find this information helpful as you continue to support the advancement of MDD care for your patients. Please continue listening for additional Important Safety Information, and click the link beneath this video for the Full Prescribing Information.
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, that is, MAOIs. Serotonin syndrome signs and symptoms may include mental status changes (for example, agitation, hallucinations, delirium, and coma), autonomic instability (for example, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (for example, tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and gastrointestinal symptoms (for example, 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 co administered 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 than2-foldincreasein 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 greater than or equal to 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.
Please see Full Prescribing Information, including Boxed WARNING regarding Suicidal Thoughts and Behaviors, by clicking on the link below this video.
1 TRINTELLIX (vortioxetine) prescribing information. Takeda Pharmaceuticals. 2023.
2 Costa SL, Genova HM, DeLuca J, Chiaravalloti ND. Mult Scler. 2017;23(6):772-789.
3 McIntyre RS, Lophaven S, Olsen CK. Int J Neuropsychopharmacol. 2014;17(10):1557-1567.
4 Mahableshwarkar AR, Zajecka J, Jacobson W, Chen Y, Keefe RSE. Neuropsychopharmacology. 2015;40(8):2025-2037.
5 FDA updates TRINTELLIX® (vortioxetine) label to include data showing improvement in processing speed, an important aspect of cognitive function in acute Major Depressive Disorder (MDD). GlobeNewswire News Room. Published May 2, 2018. Accessed February 24, 2025.
6 Data on file. Takeda Pharmaceuticals.
US-VOR-1683v1.0 05/25
