Trintellix (Vortioxetine) Side Effects, Cost, Dosage, Prescribing Information For Major Depression | Sayeda Masruh, PharmD Intern | RxEconsult
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Trintellix (vortioxetine) Side Effects, Cost, Dosage, Prescribing Information for Major Depressive Disorder (MDD) Category: Depression, Compulsion, Anxiety by - February 7, 2015 | Views: 63356 | Likes: 1 | Comment: 0  

Brintellix for major depression
 
Brand Name: Trintellix (Name changed from Brintellix 05/16)
Generic Name: vortioxetine
 
Medication Class: Selective Serotonin Reuptake Inhibitor (SSRI)
Manufacturer: Takeda Pharmaceuticals America Inc.
FDA Approval Date: September 30, 2013
Similar Drug: Prozac (fluoxetine), Zoloft (sertraline)
 
What is Trintellix and how does it work?

Trintellix is an antidepressant medication which affects certain chemicals in the brain. The active ingredient in Trintellix is called vortioxetine. Trintellix is approved by FDA for the treatment of major depressive disorder (MDD) in adults. Major depressive disorder, also known as major depression is a mental condition that affects a person’s ability to work, sleep, study, eat, and enjoy regular activities of life.

It is not completely understood how Trintellix works for depression. Trintellix acts on several serotonin receptors (5-HT1A, 5-HT1B, 5-HT3, 5-HT1D and 5-HT7) receptors.  However the clinical importance of these activities is not known yet. In the brain, Trintellix inhibits the reuptake of serotonin (5-HT) and thereby increases the activity of serotonin. Serotonin is a neurotransmitter, a  chemical that nerves use to communicate. Serotonin is involved in the regulation of mood and other functions in the central nervous system (CNS). It is believed that an imbalance in serotonin levels may affect human mood changes and leads to depression.

What is Trintellix used for treating?

Trintellix is used for the treatment of Major Depressive Disorder (MDD) in adults.

How effective is Trintellix?

The efficacy of Trintellix for the treatment of MDD in adults was analyzed in six randomized, double-blind, placebo-controlled, fixed-dose studies (including 1 study in elderly) and one maintenance study. About 2,700 patients participate in the study.

5 studies in adults Patients (aged from 18 to 75 years)

Patients were randomized to Trintellix 5, 10, 15 or 20 mg or placebo one time daily for 6 to 8 weeks in these trials. All the studies except study 2 used the Montgomery-Asberg Depression Rating Scale (MADRS) score as the primary efficacy measure, whereas study 2 used the Hamilton Depression Scale (HAMD-24) score. 

In study 1 mean MADRS changes from baseline to end of the study were -20.4, -20.2 and -14.5 for Trintellix  5 mg, 10 mg, and placebo group. In this trial Trintellix, 5 and 10 mg were superior to placebo.

In study 2 mean HAMD-24 changes from baseline to end of the study were -15.4, -16.2 and -11.3 for Trintellix  5 mg, 10 mg, and placebo group. Here Trintellix 10 mg was superior compared to placebo.

In study 3 mean MADRS changes from baseline to endpoint were -17.2, -18.8 and -11.7 for Trintellix 15 mg, 20 mg, and placebo group. Trintellix 15 and 20 mg were superior to placebo in this study.

In study 4 mean changes from baseline were -14.3, -15.6 and -12.8 for Trintellix 15 mg, 20 mg, and placebo group. Trintellix 20 mg exhibited superior results compared to placebo.

In study 5 mean change from baseline to end of the study was -13.0, -14.4 and -10.8 for Trintellix 10 mg, 20 mg, and placebo group. Trintellix 20 mg showed superiority over the placebo group.

1 study in elderly patients (aged from 64 to 88 years)

Trintellix 5 mg was superior to placebo in relieving depressive symptoms. The mean changes in HAMD-24 from baseline were -13.7 and -10.3 for Trintellix 5 mg and that of placebo.

One long-term maintenance study (24 to 64 weeks duration)

It was observed that patients treated with Trintellix 5 or 10 mg had a statistically significantly longer time to recurrence of depressive episodes than patients treated with placebo. The risk of recurrence during the first 24 weeks was two times greater in the placebo group compared to the Trintellix group; 13% of Trintellix treated patients experienced a recurrence of depression symptoms versus 26% of patients in the placebo group.

Next: Side Effects, Warnings

 


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