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VP-VHX-896-3201: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients with Major Depressive Disorder

Phase 3Phase IIIRecruiting

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of Milsaperidone (VHX-896) as adjunctive therapy in patients with Major Depressive Disorder (MDD). The study targets adults aged 18–65 with a confirmed DSM-5-TR diagnosis of MDD who have had an inadequate response to at least one antidepressant. Treatment consists of a short-term double-blind phase of 6 weeks with an optional open-label extension of approximately 52 weeks.

Study details:

The study uses Protocol Number VP-VHX-896-3201 (Amendment 2. 0, 17 Jan 2025). The Pre-Randomization Phase includes Screening (Day –14 to –1) and Baseline (Day 0).

The Short-Term Double-Blind Phase consists of a 7-day titration period followed by 5 weeks of treatment (6 weeks total). An Optional Open-Label Extension (OLE) includes a 7-day titration and 51 weeks of maintenance. The investigational product is Milsaperidone (VHX-896) oral tablets (1 mg, 6 mg, 12 mg), dose titrated to 12 mg/day (6 mg bid), with dose adjustment for CYP2D6 poor metabolizers or those on CYP2D6/3A4 inhibitors (remain on 6 mg bid).

Treatment is adjunctive to stable antidepressant therapy. Participant compensation is $125 per visit.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Adults 18–65 years old
  2. DSM-5-TR diagnosis of MDD confirmed by SCID-5-CT and medical history/record
  3. Current MDE: ≥8 weeks and ≤24 months prior to screening
  4. MADRS ≥24 and CGI-S ≥4 at screening & baseline
  5. QIDS-SR-16 ≥14 at screening & baseline
  6. Currently inadequate response (<50% improvement) to ≥1 antidepressant, at adequate dose ≥6 weeks (from allowed list: bupropion, citalopram, duloxetine, escitalopram, fluoxetine, levomilnacipran, milnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone, vortioxetine)

Exclusion criteria

  1. Lifetime diagnosis: Schizophrenia, Bipolar Disorder, other psychotic disorders
  2. Current primary diagnosis (within 6 months) of anxiety disorders (panic, GAD, OCD, PTSD), eating disorders, or severe personality disorders
  3. ≥25% reduction in MADRS or QIDS-SR-16 between screening and baseline
  4. Significant suicide risk (C-SSRS item 4/5, MADRS item 10 ≥5, or suicide attempt in last 2 years)
  5. First MDE onset at age ≥60
  6. Unstable medical/psychiatric conditions contraindicating participation
  7. In the current episode, was treated with MAOI, tricyclic antidepressants, or antidepressants other than those allowed during the study
  8. Other investigational product in last 30 days
  9. Substance use disorder (SUD) in past 6 months

Eligibility

Age eligible for study : 18 Years to 65 Years

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start: 2026-10-01

Primary completion:

Study completion finish:

study type

Study type

Drug

phase

Phase

    Phase 3Phase III

trial

Study ID

RR-113D82878B4B4F4D9

Intervention or treatment

Drug: Milsaperidone (VHX-896)

Drug: Placebo

Conditions

  • Major Depressive Disorder

  • Condition: Major Depressive Disorder

  • Drug: Milsaperidone (VHX-896) and other drugs

  • Las Vegas, Nevada, United States

  • Sponsor: Redbird Research

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Are you running this trial?

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Research sites nearby

Closest Location:

Redbird Research

Select from list below to view details:

  • Redbird Research

    Las Vegas, Nevada, United States

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Who is running the clinical trial?

RR

Redbird Research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
Experimental: Milsaperidone (VHX-896)
  • Milsaperidone oral tablets titrated to 12 mg/day (6 mg bid) as adjunctive therapy to stable antidepressant treatment.
Milsaperidone (VHX-896)
    Placebo Comparator: Placebo
    • Matching placebo as adjunctive therapy to stable antidepressant treatment.
    Placebo

      What is the study measuring?

      Primary Outcome

      Secondary Outcome

      Are you running this trial?If you're a clinic or sponsor, you can claim this study.
      Claim this trial

      References

      Clinical Trials Gov: VP-VHX-896-3201: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients with Major Depressive Disorder

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