Trintellix (vortioxetine) is a prescription medication approved for the treatment of Major Depressive Disorder (MDD) in adults. While primarily known for its antidepressant effects, concerns about potential weight changes are common among individuals considering or currently taking this medication. This article aims to provide a comprehensive overview of the relationship between Trintellix and weight, drawing upon clinical trial data, post-approval reports, and expert opinions.
What is Trintellix?
Trintellix (vortioxetine) is an antidepressant medication used to treat major depressive disorder (depression) in adults. Originally marketed as Brintellix, the name was changed by the FDA in June 2016 due to potential brand name confusion with another drug (Brilinta). In Europe, the name was changed to Fonksera.
The exact mechanism of action of Trintellix is not fully understood, but it is believed to work by increasing levels of serotonin in the brain. Trintellix is a selective serotonin reuptake inhibitor (SSRI) and serotonin receptor modulator. It differentiates itself from other antidepressants through its direct effects on various serotonin receptors, as well as inhibiting serotonin reuptake. This unique mechanism, acting as an antagonist/agonist and partial agonist, is thought to enhance its antidepressant effects and prevent desensitization of the presynaptic neuron.
Trintellix has a long half-life (approximately 66 hours) and is administered once daily.
Weight Changes: Clinical Trial Data
Clinical data classifies Trintellix as weight-neutral, meaning it neither promotes significant gain nor inhibits fat loss for most users. In placebo-controlled studies, participants on Trintellix experienced roughly the same amount of weight change as those in the placebo group.
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During short-term (6- to 8-week) studies evaluating the efficacy of TRINTELLIX on overall MDD symptom relief, the impact of TRINTELLIX on sexual side effects was also observed and recorded in those with normal sexual functioning before starting TRINTELLIX.
Using both trial results and post-approval side effect surveys, experts estimate less than 1.3% of users experience significant body weight changes during the first 6 to 8 weeks of Trintellix use, and these changes amount to -0.1 kg to +0.1 kg body weight, regardless of the dose (so a fluctuation of around 0.22 lbs).
Post-Approval Reports and Real-World Observations
However, some reports of weight gain have been received since the product was first approved. It's important to note that these reports come from outside of a clinical trial setting. In the long-term (52 weeks), clinically significant weight gain may occur in 11-13% and weight loss in 7.7% of users. The average weight increase was 1.54 lbs.
Potential Reasons for Weight Gain with Trintellix
Weight gain with Trintellix may be due to Trintellix increasing appetite (or reversing a poor appetite that is the result of untreated major depressive disorder), or because Trintellix has slightly altered a person’s hormones and metabolism. Appetite is generally poor in cases of untreated MDD, and people don’t socialize. In the cases where some people reported weight gain in non-clinical trials, it was thought likely to actually be due to the benefits of the treatment, which can lead to increased food consumption and improved social activity.
Factors to Consider
Several factors can influence weight changes during Trintellix treatment:
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- Underlying Depression: Untreated depression can affect appetite and activity levels. As Trintellix improves depressive symptoms, appetite may increase, potentially leading to weight gain.
- Lifestyle Changes: Starting Trintellix may coincide with changes in diet, exercise, or other lifestyle factors that can impact weight.
- Individual Metabolism: People respond differently to medications. Some individuals may be more prone to weight gain or loss than others.
- Hormonal Changes: Trintellix may slightly alter a person’s hormones and metabolism.
- Other Medications: Concomitant use of other medications can also contribute to weight changes.
Other Common and Serious Side Effects
Some people may experience mild or serious side effects during their Trintellix treatment.
Examples of a few of Trintellix’s commonly reported side effects include:
- nausea and vomiting
- constipation
- dry mouth
- diarrhea
Examples of mild side effects that have been reported with this drug include:
- headache
- itching
Although rare, serious side effects are possible from taking Trintellix. Serious side effects that have been reported with Trintellix include:
- risk of suicidal thoughts and behaviors in children and young adults
- serotonin syndrome (high levels of serotonin, a chemical your body produces)
- allergic reaction
- bleeding
- mania or hypomania
- glaucoma
- low sodium levels
- sexual side effects
- withdrawal symptoms, such as mood changes or headaches, if you suddenly stop taking the drug
Nausea: Nausea tops the list, affecting roughly 21-32 % of participants in short-term trials-particularly during the first two weeks. Nausea was usually considered to be mild or moderate, and its frequency was dose related. Nausea generally occurred in the first week and became less frequent over time, usually lasting for about 2 weeks. Many patients choose morning with breakfast to minimize nausea, but if the medication causes drowsiness, your prescriber might recommend bedtime dosing.
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Sexual Side Effects: As with other antidepressants, TRINTELLIX can cause sexual side effects during treatment. Sexual side effects with antidepressants are not always reported in clinical studies, partly because people may be uncomfortable discussing them. During seven short-term (6- to 8-week) studies evaluating the efficacy of TRINTELLIX on overall MDD symptom relief, the impact of TRINTELLIX on sexual side effects was also observed and recorded in those with normal sexual functioning before starting TRINTELLIX. Sexual side effects reported by females and males on TRINTELLIX vs. Comparative data are limited, but a manufacturer-supported switch study found Trintellix improved SSRI-induced sexual side effects without additional weight gain (details on Trintellix side effects from the manufacturer). Examples of sexual side effects that may occur include erectile dysfunction or a decrease in libido (sex drive).
Headache: Some people have also reported having headaches after suddenly stopping their Trintellix treatment. A headache may also be a symptom of low sodium levels, which is another side effect of Trintellix.
Allergic reaction: Like most drugs, Trintellix can cause an allergic reaction in some people. Symptoms can be mild or serious and can include:
- rash
- hives (itchy raised bumps or areas on your skin)
- itchiness
- flushing (temporary warmth, redness, or deepening of skin color)
- swelling under your skin, typically in your eyelids, lips, hands, or feet
- swelling of your mouth, tongue, or throat, which can make it hard to breathe
Risk of suicidal thoughts and behaviors in children and young adults: Trintellix has a boxed warning for the increased risk of suicidal thoughts and behaviors in children and young adults (ages 24 years and younger). A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous. Antidepressant drugs, including Trintellix, can raise the risk of suicidal thoughts and behaviors in children and young adults. This risk is highest within the first few months of taking Trintellix or when your dose is changed.
Strategies for Managing Weight While on Trintellix
If you are concerned about weight changes while taking Trintellix, consider the following strategies:
- Consult Your Doctor: Discuss your concerns with your doctor. They can help determine if Trintellix is likely contributing to weight changes and recommend appropriate strategies.
- Monitor Your Weight: Regularly monitor your weight to track any changes.
- Maintain a Healthy Diet: Focus on a balanced diet rich in fruits, vegetables, lean protein, and whole grains.
- Engage in Regular Exercise: Aim for at least 30 minutes of moderate-intensity exercise most days of the week. A brisk 10,000 steps per day supports both depression recovery and calorie burn.
- Consider a DEXA Scan: A DEXA scan provides a gold-standard snapshot of fat mass, lean mass, bone density, and visceral fat. DEXA pinpoints composition changes, enabling targeted diet and training tweaks.
- Protein Intake: Aim for 1.2-1.6 g protein per kg body weight-a range shown to preserve lean mass and support weight control (American Journal of Clinical Nutrition, 2015).
- Consider Omega-3 Fatty Acids: There is some evidence that omega-3 fatty acid supplements containing high levels of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) effectively raise the benefits of drug therapies for MDD.
Important Considerations and Warnings
- Suicidal Thoughts and Behaviors: Like all antidepressants, Trintellix carries an FDA boxed warning about the increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults. Call a doctor right away if you have these, or new or worsening depression, or new or sudden changes in mood, behavior, thoughts or feelings. TRINTELLIX has not been shown to be safe and effective for use in children.
- Discontinuation: You should not discontinue taking Trintellix suddenly without first consulting with your doctor. To help lower the risk of withdrawal from Trintellix, your doctor may slowly decrease your dosage of the drug if you’re stopping it. Missing one dose of Trintellix shouldn’t cause any specific side effects. But stopping the drug suddenly may cause side effects, including headaches.
- Drug Interactions: You are taking any blood thinners, such as NSAIDs or warfarin. It is especially important to tell your doctor if you are regularly taking aspirin, which is acting in the same manner.
- Dosage: Dose (5-20 mg) did not correlate with weight change in trials (FDA Label). Trintellix can be taken once daily with or without food. No, Trintellix tablets should not be cut in half.
- Vision Problems: Yes, Trintellix may cause vision problems. Specifically, Trintellix may cause closed-angle glaucoma in people who have other eye conditions. If you have concerns about vision problems during your Trintellix treatment, talk with your doctor or pharmacist.
- Bipolar disorder: Trintellix may cause mania or hypomania to occur. These are changes in your mood that are also symptoms of bipolar disorder. You may have a higher risk for mania or hypomania if you have bipolar disorder. If you have a history of bipolar disorder, tell your doctor before taking Trintellix. They may recommend a different treatment option for you.
- Glaucoma: If you have glaucoma or narrow angles in your eyes, taking Trintellix may make your condition worse. This is because Trintellix may cause your pupils to dilate (get bigger), which can make your condition worse. If you have glaucoma, be sure to tell your doctor before starting Trintellix. They may monitor your eyes more closely during your Trintellix treatment, or they may recommend a different medication for you.
- Bleeding disorders: Trintellix may increase your risk of bleeding.
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