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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

Must not have

Current treatment with a Monoamine Oxidase Inhibitor (MAOI)

Unwilling or unable to be sexually abstinent or not using an effective form of birth control if they are sexually active

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking a medication known as a MAOI.

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I am not using birth control and am not abstaining from sex.

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I have a diagnosed brain condition.

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I have had a bad reaction to or no improvement from vortioxetine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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.

0 / 6Eligibility criteria met