Vortioxetine for Schizophrenia
(AVIS Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byChristoph U Correll, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Northwell Health

Stay on Your Current Meds

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a 16-week, randomized, double-blind, parallel group, placebo-controlled study comparing adjunctive vortioxetine with identically appearing adjunctive placebo pills in 88 stable patients with a research diagnosis of schizophrenia determined with the Structured Clinical Interview for DSM (SCID). Patient randomization will be stratified by illness duration (i.e., \</=5 years and \>5 years) in order to allow for post-hoc analyses examining whether earlier illness moderates greater negative and /or cognitive symptom reduction in response to vortioxetine.

Research Team

Christoph U Correll, MD

Principal Investigator

North Shore LIJ

Eligibility Criteria

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.

Inclusion Criteria

HAMD-17 total score </=12

I am not currently hospitalized.

I am between 18 and 65 years old.

See 9 more

Exclusion Criteria

Mental retardation by history and estimated IQ <70 (WRAT-III Word Reading)

Autism-spectrum disorder diagnosis by history

Active substance abuse or dependence in the past 8 weeks

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Treatment Details

Interventions

Placebo (Other)
Vortioxetine (Serotonin Reuptake Inhibitor)

Trial OverviewThe 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.

Participant Groups

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.