Evaluating Safety and Efficacy of VV119 in Acute Schizophrenia Adults
ConditionSchizophrenia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVigonvita Life Sciences
About this trial
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.
Eligibility criteria
Qualifiers
Male or female participants, 18-65 years,inclusive, at screening.
Body Mass Index of 18.5 to 35.0kg/m2 , and body weight no less than 50.0kg (males), body weight no less than 45.0kg (females).
Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 criteria and confirmed by Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorder Studies (MINI).
Participant is experiencing an acute exacerbation or relapse of symptoms, with onset less than 2 months before screening:a.Participans who have been recently hospitalized or who would benefit from hospitalization for an acute exacerbation or relapse of schizophrenia;b.If hospitalized at screening, the participant's current admission for acute exacerbation shall be ≤2 weeks.
Disqualifiers
Any primary DSM-5 disorder other than schizophrenia.
Investigator-assessed treatment-resistant schizophrenia: participants who failed adequate sequential monotherapy with ≥2 structurally distinct, potent antipsychotics for positive symptoms,Each drug was given at ≥600 mg/day chlorpromazine equivalents for ≥6 consecutive weeks with poor efficacy.
Subjects with a >20% reduction in total PANSS score from screening to baseline. Reduction rate = (Screening total PANSS score - Baseline total PANSS score) / (Screening total PANSS score - 30).
Per investigator assessment via the Columbia-Suicide Severity Rating Scale (C-SSRS), participants with suicidal risk/intent in the 6 months before screening (answered "Yes" to C-SSRS Ideation Item 4 or 5) or any actual suicidal behavior within 12 months prior are excluded. Non-suicidal self-injury in the past year is not exclusionary, though participants with substantial current self-harm risk per clinical judgment will still be excluded.
Trial design
Treatments tested in this trial
- VV119 2mg
- VV119 4mg
- VV119 6mg
- Aripiprazole tablet
- Placebo
Treatment groups
500 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov