Evaluating Safety and Efficacy of VV119 in Acute Schizophrenia Adults

Sponsor
Vigonvita Life Sciences
Study ID
NCT07703956
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • VV119 2mg — DRUG
    VV119 capsules 1 capsule (2mg/capsule) + VV119 capsules placebo 2 capsules + aripiprazole tablet placebo 2 tablets
  • VV119 4mg — DRUG
    VV119 capsules 2 capsules (2mg/capsule) + VV119 capsules placebo 1 capsules + aripiprazole tablet placebo 2 tablets
  • VV119 6mg — DRUG
    VV119 capsule 3 capsules (2mg/capsule) + aripiprazole tablet placebo 2 tablets
  • Aripiprazole tablet — DRUG
    VV119 capsule placebo 3 capsules (2mg/capsule) + aripiprazole tablet 2 tablets
  • Placebo — DRUG
    VV119 capsule placebo 3 capsules (2mg/capsule) + aripiprazole tablet placebo 2 tablets

Study Details

This will be a multicenter, randomized, double-blind, placebo and active comparator parallel-controlled study designed to assess the safety and efficacy of VV119 (2.0 to 6.0 mg) for the treatment of adult participants diagnosed with DSM-5 schizophrenia who are in an acute exacerbation phase.

Key Dates

First listed
Jul 15, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Oct 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: VV119 capsules
    Capsule, 2 mg/4 mg /6 mg, administered orally once daily for 6 consecutive weeks
  • Active Comparator: Active Comparator
    Tablet, 20 mg , administered orally once daily for 6 consecutive weeks
  • Placebo Comparator: Placebo
    Capsule/Tablet, administered orally once daily for 6 consecutive weeks

Primary Outcome Measure

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 [ Time Frame: Baseline and Week 6 ]

Central Contacts

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