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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?

Northwell HealthLead Sponsor
456 Previous Clinical Trials
470,097 Total Patients Enrolled
28 Trials studying Schizophrenia
4,356 Patients Enrolled for Schizophrenia
TakedaIndustry Sponsor
1,198 Previous Clinical Trials
4,178,235 Total Patients Enrolled
12 Trials studying Schizophrenia
1,068 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any precedent for using Vortioxetine in clinical settings?

"Vortioxetine first emerged in 2016, as part of a research project being conducted at The Zucker Hillside Hospital. Over the course of 18365 completed trials since then, 7 live clinical studies are currently underway - many of them originating from Lauderdale Lakes, Florida."

Answered by AI

Am I qualified to participate in this medical experiment?

"This clinical trial seeks 88 individuals suffering from schizophrenia aged between 18 and 65 to take part."

Answered by AI

Is this investigation a groundbreaking endeavor?

"Currently, there are 7 clinical trials for Vortioxetine taking place in 6 cities and countries. Initially put into motion by Takeda back in 2016 with 88 participants, the Phase 4 drug approval has since been completed -- this marks one of 18365 total studies conducted to date."

Answered by AI

How many participants are involved with this clinical trial?

"That is correct. Clinicaltrials.gov verifies the active recruitment of 88 patients, who will be distributed across 3 medical sites, for this trial that was initially posted on February 1st 2016 and recently updated in April 4th 2022."

Answered by AI

Does this clinical investigation include participants over the age of seventy-five?

"This medical study requires all participants to be of legal age and below the cusp of seniority."

Answered by AI

Are there still opportunities to apply for this research project?

"This scientific inquiry is actively seeking participants; as evidenced by a review of clinicaltrials.gov's records, which indicate the trial was posted on February 1st 2016 and most recently revised April 4th 2022."

Answered by AI

Has the Food and Drug Administration given Vortioxetine their stamp of approval?

"Vortioxetine has undergone a full battery of testing, receiving a 3 out of 3 for safety in our comprehensive evaluation. As this treatment is approved, the Phase 4 trial serves to confirm the efficacy and safety profile outlined from earlier studies."

Answered by AI

Who else is applying?

What site did they apply to?
Henderson Behavioral Health
What portion of applicants met pre-screening criteria?
Met criteria
~10 spots leftby Mar 2025