Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Milsaperidone, Placebo.
- Who it may be relevant to
- Registry conditions: Major Depressive Disorder (MDD). Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Bulgaria, Czechia, Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Milsaperidone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Overview
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]
Eligibility criteria
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
- Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 21 centers
- Vanda Investigational Site — Phoenix
- Vanda Investigational Site — Little Rock
- Vanda Investigational Site — Garden Grove
- Vanda Investigational Site — Lemon Grove
- Vanda Investigational Site — Orange
- Vanda Investigational Site — San Jose
- Vanda Investigational Site — Walnut Creek
- Vanda Investigational Site — Colorado Springs
- … and 13 more centers
Czechia · 6 centers
- Vanda Investigational Site — Brno
- Vanda Investigational Site — Pilsen
- Vanda Investigational Site — Poruba
- Vanda Investigational Site — Prague
- Vanda Investigational Site — Prague
- Vanda Investigational Site — Prague
Poland · 6 centers
- Vanda Investigational Site — Bialystok
- Vanda Investigational Site — Bydgoszcz
- Vanda Investigational Site — Gdansk
- Vanda Investigational Site — Katowice
- Vanda Investigational Site — Katowice
- Vanda Investigational Site — Suchy Las
Bulgaria · 5 centers
- Vanda Investigational Site — Sofia
- Vanda Investigational Site — Sofia
- Vanda Investigational Site — Sofia
- Vanda Investigational Site — Targovishte
- Vanda Investigational Site — Varna
Identifiers
NCT: NCT06830044 · VP-VHX-896-3201