TV-44749 for Schizophrenia (SOLARIS Trial)

Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new medication called TV-44749 to see if it helps adults with schizophrenia, especially those with worsening symptoms. The medication likely works by balancing brain chemicals to reduce symptoms. The study will last over a year, with different phases to test both its effectiveness and safety.

Eligibility Criteria

Adults with recent schizophrenia flare-ups, a BMI of 18-40, and diagnosed over a year ago can join. Women must not plan pregnancy and use contraception. Excluded are those hospitalized for over 14 days recently, at risk of violence or suicide, on certain antipsychotics or treatments like clozapine in the past year, have significant other mental health diagnoses or substance abuse issues.

Inclusion Criteria

I have been diagnosed with schizophrenia for over a year.

My schizophrenia symptoms worsened in the last 8 weeks, needing hospital care.

Exclusion Criteria

I do not have severe mental health issues, significant brain injuries, Alzheimer's, other dementias, or intellectual disabilities that would affect my study participation.

I was in the hospital for more than 14 days due to my current health issue, not for social or administrative reasons.

I am currently on long-acting injectable antipsychotics.

I am taking more than 20 mg of olanzapine daily.

Treatment Details

The trial tests TV-44749's effectiveness in adults with schizophrenia across three different doses compared to a placebo. It assesses improvement from baseline to week 56 with weekly then monthly check-ins.

4Treatment groups

Experimental Treatment

Placebo Group

Group I: TV-44749 - Dose level 3Experimental Treatment1 Intervention

High dose regimen

Group II: TV-44749 - Dose level 2Experimental Treatment1 Intervention

Medium dose regimen

Group III: TV-44749 - Dose level 1Experimental Treatment1 Intervention

Low dose regimen

Group IV: PlaceboPlacebo Group1 Intervention

Matching Placebo