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TV-44749 for Schizophrenia (SOLARIS Trial)
SOLARIS Trial Summary
This trial studies the effectiveness of TV-44749 to treat schizophrenia in adults, and assesses its safety and tolerability. Weekly visits for 8 weeks, then monthly with weekly calls. Up to 61 weeks total.
SOLARIS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSOLARIS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SOLARIS Trial Design
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Who is running the clinical trial?
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- I am currently on long-acting injectable antipsychotics.My schizophrenia symptoms worsened in the last 8 weeks, needing hospital care.My overall health, including heart and blood tests, is good.I have taken clozapine or had electroconvulsive therapy in the last year.Based on your medical history and assessment by the investigator, it appears that you may be at a high risk for suicide.I am taking more than 20 mg of olanzapine daily.You have a history of violent behavior or are at high risk of engaging in violent behavior, as determined by your medical history or the judgment of the study investigator.I was in the hospital for more than 14 days due to my current health issue, not for social or administrative reasons.I have been diagnosed with schizophrenia for over a year.I have a mental health condition that is not schizophrenia but significantly affects my daily life.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 agree not to become pregnant and will use effective birth control during and 70 days after the study.I responded well to antipsychotic treatment, excluding clozapine, in the last year.You are allergic to olanzapine or any of the ingredients in TV-44749 or the oral form of olanzapine.I've had severe reactions to antipsychotic drugs or delirium from a medical condition.You have a moderate to severe problem with drugs or alcohol, according to the official guidelines (DSM-5), within the past 6 months. This doesn't include problems related to caffeine or nicotine.
- Group 1: TV-44749 - Dose level 1
- Group 2: TV-44749 - Dose level 2
- Group 3: TV-44749 - Dose level 3
- Group 4: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Can I partake in this medical experiment?
"To participate in this research, individuals with schizophrenia must be aged between 18 and 65. Currently, the team is seeking to enrol up to 640 participants."
Is enrollment for the trial open to individuals aged 35 or older?
"This particular trial is only open to applicants aged 18-65. For those under the age of 18 and over 65, there are 47 trials and 177 trials respectively catered for them."
Does this research program have an open enrollment period?
"The information found on clinicaltrials.gov reveals that this research is now recruiting and was originally posted online at the start of January 24th 2023, with its most recent update taking place on February 21st 2023."
Has the second dosage of TV-44749 obtained regulatory acceptance?
"The safety of TV-44749 - Dose level 2 is rated a 3 due to its Phase 3 status, which indicates that there are multiple rounds of data supporting efficacy and safety."
What is the geographical scope of this inquiry?
"At the moment, this research is being conducted in 4 distinct sites: Anaheim, Gaithersburg, Dallas and another four. To make participation easier on you it might be best to choose a study site closest to your location so that travel requirements are minimalised."
What is the current size of the participant pool for this research project?
"To ensure that the research yields meaningful results, Teva Branded Pharmaceutical Products R&D, Inc. must recruit 640 appropriate candidates for this trial from their sites in Anaheim and Gaithersburg."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How responsive is this trial?
Average response time
- < 2 Days
Most responsive sites:
- Teva Investigational Site 15468: < 48 hours
- Teva Investigational Site 15457: < 48 hours
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