NCT06830044 · Vanda Pharmaceuticals
Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive Disorder
What this study is about
The purpose of this study is to determine the effectiveness and safety of milsaperidone compared to placebo as adjunctive therapy in patients with Major Depressive Disorder
View original scientific description
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
Interventions
DRUG
Milsaperidone
Oral milsaperidone
DRUG
Placebo
Oral placebo
Primary outcome measures
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 6 weeks
The MADRS is a clinician-rated 10 item scale. Individual item scores are summed for a total possible score of 0 to 60 with a higher score indicating increased severity of depressive symptoms.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or female patient 18 to 65 years of age, inclusive;
- Meets DSM-5-TR criteria for MDD
- Currently having an inadequate response to antidepressant therapy as confirmed by the Investigator using the Antidepressant Treatment Response Questionnaire (ATRQ)
Exclusion criteria
- Within the patients lifetime, has a confirmed DSM-5-TR psychiatric diagnosis other than MDD
- Within 6 months of Screening, has a confirmed DSM-5-TR psychiatric diagnosis other than MDD that is a primary diagnosis
- Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment
Where
- Phoenix, Arizona
- Little Rock, Arkansas
- Garden Grove, California
- Lemon Grove, California
- Orange, California
- San Jose, California
- Walnut Creek, California
- Colorado Springs, Colorado
- Fort Myers, Florida
- Miami, Florida
- Tampa, Florida
- Chicago, Illinois
And 8 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations