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Vortioxetine for Schizophrenia (AVIS Trial)

Phase 4
Waitlist Available
Led By Christoph U Correll, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-65 years old
SCID diagnosis of schizophrenia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

AVIS Trial Summary

This trial will compare the effects of the drug vortioxetine to placebo in 88 patients with schizophrenia. The trial will last 16 weeks, and patients will be stratified by illness duration.

Who is the study for?
This trial is for adults aged 18-65 with schizophrenia, specifically those who have been stable on antipsychotic medication for at least 3 months. Participants should not have used antidepressants recently and must score a certain level on the PANSS Negative subscale. They cannot join if they have brain disease, autism, serious medical issues affecting cognition, recent substance abuse, are pregnant or breastfeeding, or have an intolerance to vortioxetine.Check my eligibility
What is being tested?
The study tests whether adding Vortioxetine to current treatment helps reduce negative symptoms of schizophrenia compared to a placebo. It's a controlled test lasting 16 weeks where patients don't know if they're getting the real drug or a fake one (double-blind). The participants are chosen randomly and split into two groups based on how long they've had their diagnosis.See study design
What are the potential side effects?
Vortioxetine may cause side effects like nausea, headaches, dry mouth, dizziness and sexual dysfunction among others. Since it's being tested in people with schizophrenia as an add-on therapy, monitoring will be important to distinguish between existing symptoms and new side effects.

AVIS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have been diagnosed with schizophrenia.

AVIS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Negative Symptom Assessment Scale (NSA-16) total score from baseline to endpoint
Secondary outcome measures
Change in the general composite score on the MATRICS Consensus Cognitive Battery (MCCB) from baseline to endpoint

AVIS Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: VortioxetineActive Control1 Intervention
Vortioxetine will be initiated at 10 mg / day for 1 month, followed by 20 mg /day for the remainder of the trial. The dose of vortioxetine can be lowered to 10 mg for tolerability reasons.
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo pills will be initiated at 10 mg / day for 1 month, followed by 20 mg /day for the remainder of the trial. The dose of placebo can be lowered to 10 mg for tolerability reasons.

Find a Location

Who is running the clinical trial?

TakedaIndustry Sponsor
1,208 Previous Clinical Trials
4,187,829 Total Patients Enrolled
12 Trials studying Schizophrenia
1,068 Patients Enrolled for Schizophrenia
Northwell HealthLead Sponsor
461 Previous Clinical Trials
471,047 Total Patients Enrolled
28 Trials studying Schizophrenia
4,380 Patients Enrolled for Schizophrenia
Christoph U Correll, MDPrincipal InvestigatorNorth Shore LIJ
3 Previous Clinical Trials
3,348 Total Patients Enrolled
1 Trials studying Schizophrenia
8 Patients Enrolled for Schizophrenia
~9 spots leftby Jun 2025
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