Milsaperidone for Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether milsaperidone is effective and safe when added to current treatments for individuals with Major Depressive Disorder (MDD) who aren't experiencing sufficient relief from their current antidepressants. Participants will receive either milsaperidone, a new potential drug, or a placebo, a pill with no active drug, to compare the effects. This trial suits those diagnosed with MDD who feel their current antidepressant isn't working well enough. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to the development of a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It seems like the study is for people who are already on antidepressants but not responding well, so you might continue your current treatment.
Is there any evidence suggesting that milsaperidone is likely to be safe for humans?
Research has shown that milsaperidone has undergone safety testing in earlier studies. These studies found the treatment to be generally well-tolerated. Participants mostly experienced mild to moderate side effects, which is common with many medications. When adverse events occurred, they were not severe and could be managed. Milsaperidone is being studied as an adjunctive treatment for depression, used alongside other depression treatments. While still under study, data from earlier trials suggest it has a promising safety profile for treating major depressive disorder.12345
Why do researchers think this study treatment might be promising for depression?
Milsaperidone is unique because it represents a new approach in treating depression by potentially targeting different pathways in the brain compared to existing treatments like SSRIs and SNRIs. Researchers are excited about Milsaperidone because it may offer benefits such as faster onset of action and fewer side effects, which can be significant for individuals who don't respond well to current medications. This new mechanism of action could provide a valuable alternative for those seeking relief from depression symptoms.
What evidence suggests that milsaperidone might be an effective treatment for depression?
Research has shown that milsaperidone, which participants in this trial may receive, might help treat Major Depressive Disorder when combined with other medications. Some studies have found it can improve depression symptoms when standard treatments aren't enough. Early findings suggest that milsaperidone affects brain chemicals linked to mood, offering hope for additional support to those dealing with depression. However, further research is needed to confirm these results and ensure its safety.13456
Are You a Good Fit for This Trial?
This trial is for individuals with Major Depressive Disorder (MDD) who haven't had enough improvement from their current antidepressant therapy. Participants must meet the DSM-5-TR criteria for MDD and have an inadequate response to treatment, as confirmed by a questionnaire.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive milsaperidone or placebo as adjunctive therapy for Major Depressive Disorder
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Milsaperidone
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanda Pharmaceuticals
Lead Sponsor