Depression is a common mood disorder. It is completely normal for most people to feel sad or depressed at times as a reaction to loss or life’s challenges. But when depression leads to things like feeling helpless, hopeless, or worthless and keeps you from living your life, you may need help. Treatment options for depression can include talk therapy and/or medicines. There are many different types of medicine available to treat depression, and Trintellix is one of them.
How Does Trintellix Work for Depression?
Depression is thought to be at least partly related to certain chemicals in your brain, including serotonin. When you have depression, it could be because these chemicals are not at the right levels or working the way they should. Trintellix (vortioxetine) is an antidepressant that belongs to a group of medicines called serotonin modulators. Because depression affects people differently, medicines like Trintellix work on serotonin in more than one way. Though the exact way it works is not fully understood, we know that Trintellix affects serotonin levels in the brain. It also seems to affect certain receptors or proteins that serotonin interacts with inside your brain.
How Was Trintellix Studied for Depression?
There were several studies done to see if Trintellix helped with symptoms of depression. Most of the studies compared one or more doses of Trintellix to a placebo (no medicine in it). See below for an overview of the tools used in these studies that have been validated in measuring depression severity or the effects of a new medicine.
Hamilton Depression Scale (HAMD-24): A tool designed to rate the severity of depression using 17 different categories. Lower total scores indicate less severe depression. Scores and associated depression severity are listed below:
- Normal: 0 to 7
- Mild depression: 8 to 13
- Moderate depression: 14 to 18
- Severe depression: 19 to 22
- Very severe depression: 23 or higher
Montgomery-Asberg Depression Rating Scale (MADRS): A tool designed to assess the severity of depression using 10 different categories. Lower scores mean less severe depression. Scores associated with depression severity are listed below:
- Normal or absence of symptoms: 0 to 6
- Mild depression: 7 to 19
- Moderate depression: 20 to 34
- Severe depression: 35 to 60
Clinical Global Impression of Improvement (CGI-I): A tool used by health care providers to assess a person’s functioning before and after taking a medication. Scores range from 1 (very much improved) to 7 (very much worse).
Five short-term studies (each lasting six to eight weeks) were done in adults ranging in age from 18 to 75 years (studies 1 through 5 in the results section below). One short-term study was done in adults aged 64-88 years (study 6 in the results section below). Neither the study investigators nor the people in any of these studies knew if they were taking Trintellix or a placebo. Baseline HAMD-24 and MADRS scores indicated that most people were classified as having severe or very severe depression at the beginning of the study.
There were also longer-duration studies done to see if Trintellix helped with remission (maintaining control of depression to reduce the risk of future major depression episodes). In one study, adults taking Trintellix and considered to be in remission were divided into two groups: 192 people switched to a placebo (no medicine), and 204 continued taking their dose of Trintellix. They were followed for a minimum of 24 weeks. The study measured time to relapse.
What Were the Results of the Studies?
In multiple clinical studies, Trintellix improved depression symptoms more than a placebo. The tables below show how much more symptoms improved across different doses and studies when compared to placebo (no medicine).
Short-term results
Study (Tool) | Average Baseline Score
| Change From Baseline** | Significant Differences From Placebo* |
|---|---|---|---|
Study 1 (MADRS) | Trintellix 5 mg: 34.1 Trintellix 10 mg: 34 Placebo: 33.9 | Trintellix 5 mg: -20.4 Trintellix 10 mg: -20.2 Placebo: -14.5 | Trintellix 5 mg: -5.9 Trintellix 10 mg: -5.7 |
Study 2 (HAMD-24) | Trintellix 5 mg: 32.2 Trintellix 10 mg: 33.1 Placebo: 32.7 | Trintellix 5 mg: -15.4 Trintellix 10 mg: -16.2 Placebo: -11.3 | Trintellix 10 mg: -4.9 |
Study 3 (MADRS) | Trintellix 15 mg: 31.8 Trintellix 20 mg: 31.2 Placebo: 31.5 | Trintellix 15 mg: -17.2 Trintellix 20 mg: -18.8 Placebo: -11.7 | Trintellix 15 mg: -5.5 Trintellix 20 mg: -7.1 |
Study 4 (MADRS) | Trintellix 15 mg: 31.9 Trintellix 20 mg: 32 Placebo: 31.5 | Trintellix 15 mg: -14.3 Trintellix 20 mg: -15.6 Placebo: -12.8 | Trintellix 20 mg: -2.8 |
Study 5 (MADRS) | Trintellix 10 mg: 32.2 Trintellix 20 mg: 32.5 Placebo: 32 | Trintellix 10 mg: -13 Trintellix 20 mg: -14.4 Placebo: -10.8 | Trintellix 20 mg: -3.6 |
Study 6 (HAMD-24) | Trintellix 5 mg: 29.2 Placebo: 29.4 | Trintellix 5 mg: -13.7 Placebo: -10.3 | Trintellix 5 mg: -3.3 |
*Information listed if the difference between the specific dose of Trintellix and placebo was meaningful.
**These data are based on calculations that adjust for differences between groups, known as least squares (LS) means. It is another way to compare results and may give a more accurate comparison than raw data.
Taking Trentillix may reduce the severity of your depression symptoms. Different people respond to different doses, but these studies show that doses as small as 5 mg can provide some benefit. In addition, when the study investigators examined people in these trials using the CGI-I, they concluded that Trintellix worked better than no medicine at improving symptoms of depression. Based on CGI-1 information and the changes in the MADRS and HAMD-24 scores, these studies show that Trintellix improves symptoms of depression in adults.
Now that we know Trintellix works, it is time to look at the information about controlling symptoms long-term. Trintellix has a lower depression relapse rate compared to placebo. The table below shows the relapse rates when continuing Trintellix or switching to placebo from Trintellix for people who were considered to be in remission while taking it.
Long-term results
Trintellix | Placebo | |
|---|---|---|
| Relapse rate | 27/204 (13 %) | 50/192 (26 %) |
After achieving remission with Trintellix, continuing to take it for at least 24 weeks seems to reduce your risk of relapse by about half compared to not taking any medicine.
In summary, the short-term and long-term study data confirm the following about Trintellix:
- It effectively reduces depression symptoms.
- It starts working within a few weeks.
- It helps prevent depression from returning.
Note that your results may differ from those seen in studies.
How Soon Will I Know if Trintellix Is Working?
In the studies used to see if Trintellix worked to improve symptoms of depression, some benefits were seen as early as two weeks after starting the medicine. However, improvement in symptoms of depression continued until about four to eight weeks after starting the medicine. If you have been taking Trintellix for four weeks or longer and have not noticed improvement in your symptoms, you can call your health care provider to talk about this. You may need a different dose of the medicine, or it may be time to try other options. Do not change your dose or stop taking Trintellix without consulting your health care provider.
What Should I Know About Sexual Side Effects?
Though antidepressant medicines may help improve your symptoms of depression, many of these medicines can cause side effects. Some of the side effects that often concern people are sexual side effects. These side effects can include any of the following:
- Inability to initiate or enjoy sex
- Erectile dysfunction (ED) or delayed ejaculation
- Decreased sexual desire
- Inability to achieve an orgasm
Two studies were done to compare sexual side effects between Trintellix and a common group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). These studies used the Changes in Sexual Functioning Questionnaire Short Form (CSFQ-14), which measures medicine-related changes in sexual function. It uses 14 items to define sexual function as a total score. Higher scores on the CSFQ-14 indicate better sexual function. A two- or three-point change in CSFQ-14 scores is considered a meaningful change.
The studies looked at people who were taking an SSRI and having sexual side effects from it. These patients were transitioned to another SSRI or Trintellix. Over the course of eight weeks, CSFQ-14 scores were calculated. People who switched to Trintellix had higher CSFQ-14 scores than those who switched to the SSRI.
To summarize these results, when people who had sexual side effects from an SSRI switched to Trintellix, this led to more improvement in sexual function than switching to another SSRI. After eight weeks of treatment, people taking Trintellix saw a greater improvement in sexual well-being than those taking an SSRI. Both medications seemed to continue to control depression symptoms as well as before.
Note that not everyone experiences sexual side effects, and experiences vary.
What Kinds of Drug Interactions May Happen?
Trintellix may cause problems with other medicines and vice versa. Many of these interactions are caused by the effects of Trintellix and other medicines on enzymes called cytochrome P450 (CYP). These are enzymes in your liver that metabolize or break down medicines. Some medicines may speed up, slow down, or even completely block these enzymes. When this happens, the amount of medicine in your body may increase (similar to taking too much) or decrease (similar to taking too little). Either way, this may cause problems that can sometimes be serious.
Medicines known as strong CYP2D6 inhibitors can increase your risk of side effects from Trintellix because they can increase the levels of Trintellix. If you need to take a strong CYP2D6 inhibitor while you are taking Trintellix, your health care provider may need to give you a lower dose of Trintellix to reduce your risk of side effects.
Medicines known as strong CYP inducers can reduce how well Trintellix works for you because they can quickly get rid of Trintellix by metabolizing it. Your dose of Trintellix may need to be higher if you take a strong CYP inducer.
Do not change your dose of Trintellix without instructions to do so from your health care provider. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
Are There Any Special Considerations to Know About?
If possible, you should not stop taking Trintellix abruptly. In the studies that assessed the use of Trintellix, people who stopped taking it abruptly seemed more likely to have headaches and tense muscles. When possible, you should slowly lower the dose of Trintellix over time to reduce your risk of having these side effects. If you need to stop taking Trintellix, contact your health care provider for guidance on how to stop taking it safely.
Is There Any Cost Assistance Available?
Yes. There is a cost savings and support program offered by the drugmaker that may allow you to pay as little as $10 for your prescription. Whether you are eligible depends on whether you have prescription insurance and what type of insurance you have. You can find out more by calling the drugmaker at 844-654-TRIN (844-654-8746) or by visiting their website at www.trintellix.com/savings-support.
