Changes in Sexual Functioning Questionnaire Short Form (CSFQ-14)1
The CSFQ-14 is a validated scale that measures sexual functioning, including the 3 phases of the sexual response cycle:
ARE YOUR PATIENTS STRUGGLING WITH THE OVERALL SYMPTOMS OF MDD?
TRINTELLIX was evaluated on MADRS or HAM-D24 total scores at 6 or 8 weeks.
TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults.
Individual results may vary.
Efficacy demonstrated in multiple 6- to 8-week clinical trials of TRINTELLIX
Primary endpoints in 6 randomized, placebo-controlled, double-blind, short-term studies*1 (5 mg to 20 mg once daily) in adult MDD patients
*Five studies in adults aged 18 to 75 years; One dedicated study in elderly patients aged 64 to 88 years.1
†Doses that are statistically significantly superior to placebo after adjusting for multiplicity.
The effects observed on DSST may reflect improvement in depression.
Comparative studies have not been conducted to demonstrate a therapeutic advantage over other antidepressants on the DSST.1
†Doses are statistically significantly superior to placebo: P<.001 for Study 7 and P<.05 for Study 8.1,8-10
Time to recurrence of a depressive episode* vs placebo in a long-term maintenance trial (FAS)1,11
*Recurrence of a depressive episode was defined as a MADRS total score ≥ 22 or lack of efficacy as judged by the investigators
†Remission was defined as MADRS total score ≤ 10 at both weeks 10 and 12
Abbreviations: CI, confidence interval; DSST, Digit Symbol Substitution Test; FAS, full analysis set; HAM-D24, Hamilton Depression Rating Scale; HR, hazard ratio; LOCF, last observation carried forward; MADRS, Montgomery-Åsberg Depression Rating Scale; MMRM, mixed model repeated measures
TRINTELLIX was statistically superior to escitalopram in improving SSRI-induced sexual dysfunction1
Changes in Sexual Functioning Questionnaire (CSFQ-14) total score
CSFQ-14 mean total score at baseline: TRINTELLIX 36.5, escitalopram 36.3.12
Results were based on an 8-week, head-to-head, randomized, double-blind study comparing TRINTELLIX (n=225) with escitalopram (n=222) in patients with well-treated MDD experiencing SSRI-induced sexual dysfunction as measured by the CSFQ-141,12. Patients were switched from citalopram, paroxetine, or sertraline to either TRINTELLIX or escitalopram (both groups started on 10 mg once daily, then increased to 20 mg at Week 1, followed by flexible dosing).
Patients switched to TRINTELLIX from SSRIs maintained efficacy over the 8-week study1,12
Mean change from baseline in MADRS total score
Both TRINTELLIX and escitalopram maintained efficacy during the study.1,12
Voluntary reports of sexual dysfunction with TRINTELLIX in 6-8 week controlled trials were ≤5%. Because voluntary reports of sexual dysfunction are known to be underreported, a separate, self-rated questionnaire was provided to patients prospectively in TRINTELLIX clinical studies.1
When assessed proactively in patients without sexual dysfunction at baseline, reports of treatment emergent sexual dysfunction across doses of TRINTELLIX 5 mg, 10 mg, 20 mg were 16%, 20%, 29% in males (N=212) respectively and 22%, 23% and 34% in females (N=226) respectively, compared to placebo rates of 14% in males (N=162) and 20% in females (N=135).1
Click here for more detailed information on Sexual Dysfunction Data with TRINTELLIX.
Help your patients by downloading a TRINTELLIX Savings Card.
*Patients must meet eligibility requirements. Savings will apply after patients pay their first $10 per 30-day prescription or their first $30 per 90-day prescription. Maximum savings are $100 per 30-day prescription or $300 per 90-day prescription. This offer is valid for 12 months of prescriptions.
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.
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.
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.
TRINTELLIX is indicated for the treatment of major depressive disorder in adults.