Milsaperidone for Depression
Recruiting at 1 trial location
VP
Overseen ByVanda Pharmaceuticals
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Vanda Pharmaceuticals
Must be taking: Antidepressants
Stay on Your Current MedsYou can continue your current medications while participating
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
What is the purpose of this trial?
The purpose of this study is to determine the efficacy and safety of milsaperidone compared to placebo as adjunctive therapy in patients with Major Depressive Disorder
Eligibility Criteria
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
I have been diagnosed with major depression.
My current antidepressant treatment isn't working well for me.
Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive milsaperidone or placebo as adjunctive therapy for Major Depressive Disorder
6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Milsaperidone
Trial Overview The study aims to test the effectiveness and safety of a drug called Milsaperidone when added to existing depression treatments, compared to a placebo (a substance with no active drug).
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MilsaperidoneExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanda Pharmaceuticals
Lead Sponsor
Trials
68
Recruited
19,900+
Other People Viewed
By Subject
By Trial
Related Searches
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.