In addition, patients with higher baseline depressive severity had a greater likelihood of achieving remission on all remission outcomes.
Unfortunately, Mathews et al, 14 the only study including an SSRI as well as vilazodone, did not report remission rates. The various active medication-treatment groups had numerical superiority to placebo: sustained response was seen in the However, these differences were not statistically significant. Furthermore, the remission rates for vilazodone and citalopram were essentially identical. As Rickels et al 17 mention, past clinical studies evaluating the 5-HT 1A -receptor function have concluded that the 5-HT 1A receptor is impaired in patients with depression and is involved in the pathogenesis of depression and anxiety.
Fava et al 56 also showed that patients with anxious depression were less responsive to antidepressant therapy than those with nonanxious depression. Furthermore, 5-HT 1A agonists have significant effects in patients with symptoms of anxiety and depression. What effect does vilazodone have on anxiety symptoms in depressed patients? With the exception of the HAMA Somatic Anxiety subscale, statistically significant improvements with vilazodone were also found on all other anxiety-related measures.
Of the handful of interesting results, Thase et al 19 looked at changes in the overall depression measures in the nonanxious subgroup and the anxious subgroup to analyze potential differences in treatment effects. A review of studies on ClinicalTrials.
Of these, eleven were listed as completed three with results and 13 were ongoing. These studies presumably were completed for FDA registration of vilazodone. Studies listed on ClinicalTrials. Furthermore, there was a listing for a comparison study between vilazodone and citalopram in the treatment of MDD, and a comparison between two doses of vilazodone 20 and 40 mg versus paroxetine 20 mg versus placebo on sexual functioning of healthy adults.
There was a 1-year long-term tolerability study. There were also some biological studies: one looking at genetic markers associated with response in MDD, and another examining the effects of glutamate on the anterior cingulate cortex in anxious unipolar depressives.
In summary, a number of these Phase IV studies are investigating the efficacy of vilazodone for treatment of a range of anxiety disorders. This is a logical choice, given the 5-HT 1A agonism and SRI activity of vilazodone, which in a sense combine the effects of the anxiolytic buspirone with SRI antidepressant effects.
It remains to be seen whether this pharmacological activity leads to better clinical outcome in those disorders. Similarly, the potential efficacy of vilazodone in other areas such as marijuana abuse and the tolerability of vilazodone eg, in terms of sexual side effects, as well as over long-term administration , and its benefits and tolerability for specific subpopulations of patients such as the elderly remain to be established.
Genetic markers predicting medication response, if found, would potentially be clinically useful. Does vilazodone have a higher degree of tolerability and fewer side effects than other antidepressant agents, the third hypothesized benefit of SPARI medications? In general, vilazodone does have a relatively high level of safety and tolerability in adults. The only published RCT 14 that included vilazodone and an SSRI showed generally comparable rates of discontinuation for vilazodone and citalopram: 6.
Rickels et al 11 ran an 8-week study of patients treated with vilazodone and treated with placebo, in which patients randomly assigned to vilazodone were administered doses that were titrated to 40 mg once a day. It was found that the most common treatment-emergent adverse events TEAEs in the vilazodone group were diarrhea In comparison, the placebo group had lower incidences of diarrhea 7.
Most AEs were of mild or moderate intensity. Overall, discontinuation due to AEs in the vilazodone group was seen in 19 patients 9.
In the vilazodone group, there were AEs in patients It was also found that the median duration of nausea was 4 days and diarrhea was 5 days in the vilazodone group compared with 4. Most AEs in the vilazodone group were reported in week 1 of treatment. Eighteen patients 8.
The majority of AEs were reportedly of mild or moderate intensity. Median time to initial onset of diarrhea was 2 days for vilazodone patients and 8 days for placebo patients, and median time to initial onset of nausea was 4 days for vilazodone patients and 2 days for placebo patients.
Median duration of the initial occurrence of diarrhea was 8 days for vilazodone patients and 5 days for placebo patients. Median duration after initial occurrence of nausea for both groups was 5 days. Overall, rates of discontinuation due to AEs were 5. Most AEs were of mild-to-moderate intensity; 6.
As measured by the Columbia Suicide Severity Rating Scale, there were no incidences of suicidal ideation or behavior that were reported as TEAEs during the study in either group.
Treatment-related effects on sexual function as measured by the Changes in Sexual Functioning Questionnaire CSFQ 62 , 63 were small and similar to placebo. Effects on weight were no different from placebo. They found that rates of TEAEs were similar for vilazodone 20 mg The majority of TEAEs were of mild or moderate severity.
Serious AEs were reported in four vilazodone 20 mg patients, four vilazodone 40 mg patients, and six citalopram patients. Reportedly, both vilazodone groups had greater improvement on the CSFQ relative to citalopram; differences were not statistically significant.
AEs were similar to those reported in the other RCTs, with the most common AEs being diarrhea, nausea, dizziness, and insomnia. Interestingly, the gastrointestinal side effects, including nausea and diarrhea, were demonstrated to occur very early in treatment with vilazodone, almost always within the 1st week.
Diarrhea was seen in Discontinuation due to AEs was seen in 6. Significant discontinuation-emergent scores were not observed 1 week after discontinuing vilazodone. Robinson et al 47 ClinicalTrials. There were patients, of which completed 1 full year of treatment. MADRS mean scores were Mean CGI-S improved from 4. Similarly, the CGI-I mean score improved from 3.
CSFQ mean scores observed cases improved throughout treatment for both males and females. The most frequent AEs were diarrhea Robinson et al 47 reported a mean weight increased of 1. To our knowledge, there are no reported data on the use of vilazodone in the elderly. To our knowledge, there are no reported data on the use of vilazodone in children or adolescents either. We were unable to find reports of vilazodone use in patients with comorbid substance-abuse disorders.
In Phase III studies reported by Robinson et al 47 and Khan et al, 12 active alcohol and other substance abuse were exclusions for study participation. As noted earlier, there is an ongoing study of vilazodone for treatment of marijuana abuse, listed on ClinicalTrials. All subjects will also receive contingency-management therapy and motivational enhancement therapy. Vilazodone is extensively metabolized in the liver, primarily via the CYP3A4 isoenzyme. It is also metabolized by other pathways, possibly by carboxylesterase.
It has also been found to be a significant CYP2C8 inhibitor. As such, concomitant use of vilazodone with other medications may affect plasma concentrations. There are no adequate well-controlled studies of vilazodone in pregnant women. Vilazodone is excreted into the milk of lactating rats Forest Pharmaceuticals. The effect of vilazodone on lactation and nursing in humans is unknown.
Other than transient neonatal jaundice, the child did not experience irritability or feeding or respiratory difficulties, which have been reported in neonates exposed to antidepressants during pregnancy. Differences of the observed ASEX mean scores between baseline and week 8 suggested overall slight improvement in sexual function, and apparently did not differ between vilazodone and placebo.
Khan et al 12 found that mean CSFQ scores at baseline in the vilazodone and placebo groups were At week 8, for men, mean CFSQ total score change from baseline in vilazodone patients showed improvement of 0. The most common sexual dysfunction AE was decreased libido, which was reported by 4. Overall, there were 21 sexual dysfunction AEs in the vilazodone group, and one in the placebo group. This inconsistency may reflect the difficulty in distinguishing sexual dysfunction related to antidepressants from sexual dysfunction related to depression itself.
Phelps, 70 however, has criticized these studies, stating that they are flawed by 1 enrolling patients with preexisting sexual dysfunction, rather than only patients without preexisting sexual dysfunction, and 2 the absence of an SSRI comparator. Subsequently, one study has addressed the concern of a lack of active comparator medication. Overall, following treatment, mean CSFQ scores increased in all groups, suggesting improvement in sexual functioning.
These studies do suggest that vilazodone has a relatively small adverse impact on sexual functioning. Existing data have other limitations: for instance, none of the cited studies enrolled only patients without preexisting sexual dysfunction. Two ongoing studies listed on ClinicalTrials.
At this point, vilazodone cannot be recommended as a first-line drug for treatment of depression, primarily for cost reasons. It has a generally similar mechanism of action to existing drugs. Despite theoretical advantages of SPARI drugs, such as more rapid onset of action, more complete response, or fewer side effects, as postulated by Stahl, 9 these actions have not been strongly supported to date in published studies. Furthermore, data for superiority in subpopulations such as depression with high anxiety or anxious distress or fewer side effects such as sexual dysfunction is not convincing.
Therefore, there does not yet appear to be a compelling case for use of vilazodone as a first-line antidepressant drug. As noted earlier, vilazodone could potentially be useful for various subgroups of patients, such as those with depression and comorbid anxiety, and possibly patients with sexual side effects on SSRIs or other antidepressants. Also, it is possible that some nonresponders to SSRIs and SNRIs will respond to vilazodone: some such individuals may have abnormalities of 5-HT 1A function that are not addressed by reuptake inhibition of serotonin or norepinephrine.
The 5-HT 1A partial agonism of vilazodone may indeed have benefits for particular subgroups of patients, as suggested based on pharmacological hypotheses 9 and animal data. Given the worse outcome for MDD patients with comorbid anxiety symptoms 56 or in DSM-5 terms, anxious distress , it would be valuable to find effective monotherapies that could treat both the mood disorder and coexisting anxiety symptoms.
In addition, vilazodone could be useful for patients with primary anxiety-disorder diagnoses, such as generalized anxiety disorder, social phobia, and panic disorder. For each of these disorders, it would be essential to determine whether vilazodone is effective compared to placebo, and then whether it has additional benefit, in terms of efficacy or tolerability, in comparison to SSRIs. It would also be interesting to know whether patients with obsessive—compulsive disorder respond to vilazodone in comparison to placebo and SSRIs.
The same would apply to those patients who have MDD along with comorbid anxiety disorders. Similarly, in posttraumatic stress disorder, which the DSM-5 has categorized among the trauma- and stress-related disorders, it would be valuable to determine whether vilazodone is efficacious, both in comparison to placebo and SSRIs; in particular, the impact of 5-HT 1A partial agonists on fear conditioning 71 and the literature on buspirone augmentation of SSRI medication.
Other unmet needs for antidepressants in general include faster-onset medications and antidepressant medications with improved tolerability, with lower rates of weight gain, sexual dysfunction, and other common side effects, and medications with better tolerability for patients with comorbid medical conditions.
The relative economic outcomes for vilazodone treatment versus other agents should be determined. DH has conducted studies that have been funded by companies including Pfizer current , and past studies that were funded by companies including Eli Lilly, Wyeth, Bristol-Myers Squibb, and Forest Pharmaceuticals.
The most common side effects of Lexapro are nausea, headache, diarrhea, increased sweating, and dry mouth. Other possible side effects of Lexapro may include constipation and flu-like symptoms. Viibryd and Lexapro, like other antidepressants , may cause changes in appetite. This could lead to weight gain or weight loss in some people. Both Viibryd and Lexapro can also cause sexual side effects. The use of either antidepressant may cause a decreased sex drive libido.
Viibryd and Lexapro can also cause sexual dysfunction, such as erectile dysfunction, and problems with ejaculation. Because Viibryd also acts as a partial 5-HT1A receptor agonist, it may have a lower risk of sexual side effects than Lexapro.
This may not be a complete list of adverse effects that can occur. Please refer to your doctor or healthcare provider to learn more. Viibryd and Lexapro should be avoided while taking monoamine oxidase inhibitors MAOIs , such as selegiline and phenelzine.
Viibryd or Lexapro should not be taken within 14 days of discontinuing an MAOI or there may be an increased risk of serotonin syndrome. Viibryd and Lexapro should also be avoided or monitored with other serotonergic drugs like antidepressants, which can increase the risk of serotonin syndrome. Taking these drugs together may increase the risk of bleeding.
Because Viibryd and Lexapro are primarily metabolized in the liver, their absorption may be affected by drugs that alter certain liver enzymes. Some antifungals and antibiotics can increase the levels of Viibryd and Lexapro in the blood, which can increase the risk of adverse effects. Other drugs like certain anticonvulsants can decrease blood levels of Viibryd and Lexapro, which can decrease their overall effectiveness.
Lexapro is known to potentially cause a heart rhythm disturbance called QT prolongation. Taking Lexapro with certain antipsychotic drugs like aripiprazole or quetiapine may increase the risk of QT prolongation.
Antidepressants like Viibryd or Lexapro may increase the risk of suicidal thoughts, especially in young adult patients. Those taking Viibryd or Lexapro should be monitored for worsening depression and suicidal thoughts. The risk is increased when antidepressants are taken with other serotonergic drugs. Signs and symptoms of serotonin syndrome may include fast heart rate, increased blood pressure, sweating, tremors, and fever.
Some people may be screened for a history of bipolar disorder prior to starting treatment with Viibryd or Lexapro. These antidepressants have the potential to activate mania or hypomania in some individuals with bipolar disorder. Viibryd and Lexapro should be tapered or discontinued gradually if needed. Abrupt discontinuation of antidepressants could increase the risk of withdrawal symptoms.
Viibryd is a brand-name prescription drug used to treat major depressive disorder MDD. It is the brand name for vilazodone. It is usually taken as a 20 mg tablet once daily with food. It is also approved to treat generalized anxiety disorder GAD.
Viibryd comes in 10 mg, 20 mg, and 40 mg tablets. Most likely, your doctor will start you with a 10 mg dose once daily for 7 days. After that, your dose will be increased to 20 mg once daily for 7 days. Depending on how well the drug is working for you and how your body reacts to it, your doctor will either tell you to continue taking 20 mg once daily or he or she may increase your dose to 40 mg once daily.
Always take Viibryd with food. The graphic below shows the recommended dosing schedule for Viibryd. Your healthcare provider may provide different instructions for you. Always follow your healthcare provider's instructions on what dose to take. VIIBRYD and other antidepressants may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
Some people, including those with or a family history of depression, bipolar illness, or a history of suicidal thoughts or actions may have a higher risk of suicidal thoughts or actions. Pay close attention to and call your healthcare provider right away to report any new or sudden changes in mood, behavior, thoughts or feelings. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:.
Stop taking VIIBRYD and call your healthcare provider or go to the nearest emergency room right away if you have any of the following: agitation; hallucinations; confusion, coma; fast heart beat; blood pressure changes; dizziness; sweating; flushing; high body temperature; tremors, stiff muscles, or muscle twitching; loss of coordination; seizures; nausea, vomiting or diarrhea.
Tell your healthcare provider right away about unusual bleeding or bruising. Manic episodes: Symptoms may include greatly increased energy; severe trouble sleeping; racing thoughts; reckless behavior; unusually grand ideas; excessive happiness or irritability; talking more or faster than usual. Stopping VIIBRYD suddenly may cause serious side effects including: nausea; sweating; changes in mood; headache; irritability and agitation; tiredness; dizziness; problems sleeping; electric shock sensation; hypomania; anxiety; ringing in your ears; confusion; seizures.
Call your healthcare provider if you have changes in your vision or eye pain.
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