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TV-44749 for Schizophrenia (SOLARIS Trial)
Phase 3
Recruiting
Research Sponsored by Teva Branded Pharmaceutical Products R&D, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The participant has a current confirmed diagnosis of schizophrenia according to the DSM-5, for >1 year
The participant has exacerbation of schizophrenia that started ≤8 weeks prior to screening and would benefit from psychiatric hospitalization or continued hospitalization for symptoms of schizophrenia.
Must not have
The participant has a known history of the following: (a) borderline personality disorder, antisocial personality disorder, or bipolar disorder; (b) traumatic brain injury causing ongoing cognitive difficulties, Alzheimer's disease, or another form of dementia, or any chronic organic disease of the central nervous system; and (c) intellectual disability of a severity that would impact ability to participate in the study.
The participant was hospitalized for >14 days (with the exception of social or administrative hospitalization) in the current exacerbation episode prior to screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8 to week 60
Awards & highlights
Summary
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects aren't listed here, common ones for antipsychotic medications include drowsiness, weight gain, dry mouth, restlessness and sometimes more serious effects like movement disorders or metabolic changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with schizophrenia for over a year.
Select...
My schizophrenia symptoms worsened in the last 8 weeks, needing hospital care.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have severe mental health issues, significant brain injuries, Alzheimer's, other dementias, or intellectual disabilities that would affect my study participation.
Select...
I was in the hospital for more than 14 days due to my current health issue, not for social or administrative reasons.
Select...
I am currently on long-acting injectable antipsychotics.
Select...
I am taking more than 20 mg of olanzapine daily.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 8 to week 60
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8 to week 60
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline to week 8 in the Positive and Negative Syndrome Scale (PANSS) total score
Secondary study objectives
Change from Baseline in Abnormal Involuntary Movement Scale (AIMS) total score
Change from Baseline in total score in Abnormal Involuntary Movement Scale (AIMS)
Change from baseline in Barnes Akathisia Rating Scale (BARS) total score
+16 moreTrial Design
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
Find a Location
Who is running the clinical trial?
Teva Branded Pharmaceutical Products R&D, Inc.Lead Sponsor
251 Previous Clinical Trials
3,484,738 Total Patients Enrolled
5 Trials studying Schizophrenia
1,127 Patients Enrolled for Schizophrenia
Teva Medical Expert, MDStudy DirectorTeva Branded Pharmaceutical Products R&D, Inc.
93 Previous Clinical Trials
38,141 Total Patients Enrolled
5 Trials studying Schizophrenia
1,127 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: TV-44749 - Dose level 1
- Group 2: TV-44749 - Dose level 2
- Group 3: TV-44749 - Dose level 3
- Group 4: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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.
Schizophrenia Patient Testimony for trial: Trial Name: NCT05693935 — Phase 3
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