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Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia
Led by Reviva Pharmaceuticals · Updated on 2024-12-19
690
Participants Needed
18
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is to evaluate the effect and safety of Brilaroxazine in patients with acute schizophrenia compared to the placebo short and long-term. Brilaroxazine will be given at fixed doses of 15 mg or 50 mg once daily over 4 weeks, then in the long-term flexible doses 15-50mg daily over a period of 52 weeks.
CONDITIONS
Official Title
Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 65 years
- Able to read, understand, and sign an IRB/IEC-approved informed consent form before screening
- Diagnosed with schizophrenia
You will not qualify if you...
- History of treatment resistance including no or minimal response to at least two antipsychotic treatments lasting 28 days or longer at maximum tolerated doses
- Lifetime use of clozapine
- Electroconvulsive therapy (ECT) for schizophrenia within the past 5 years
- Treatment-nafve for schizophrenia
- Current diagnosis other than schizophrenia or a comorbid diagnosis that primarily causes symptoms and functional impairment
- Current psychotic disorder other than schizophrenia or behavioral issues due to substance abuse
- Moderate-to-severe substance use disorder within 6 months before screening (excluding caffeine and nicotine)
- History of traumatic brain injury causing ongoing cognitive problems, Alzheimer's disease, dementia, or other chronic central nervous system diseases
- Intellectual disability severe enough to affect study participation
- Current primary DSM-5 diagnosis other than schizophrenia including schizoaffective disorder, major depressive disorder, PTSD, OCD, manic episode, hypomania, panic disorder, delirium, amnestic or cognitive disorders, or certain personality disorders
- Use of antipsychotic medication within the screening period (minimum 3 days before baseline and during the study)
- Use of prohibited medications including MAO inhibitors, CNS stimulants, potent CYP3A4/5 inducers or inhibitors within 28 days before baseline
- Antipsychotic depot medication within 5 half-lives before baseline
- Positive urine drug screen for drugs of abuse related to moderate-to-severe substance use disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Reviva site
Phoenix, Arizona, United States, 85012
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2
Reviva site
Bentonville, Arkansas, United States, 72712
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3
Reviva site
Little Rock, Arkansas, United States, 72211
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4
Reviva site
Rogers, Arkansas, United States, 72758
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5
Reviva site
Garden Grove, California, United States, 92845
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6
Reviva site
Lemon Grove, California, United States, 92945
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7
Reviva site
Riverside, California, United States, 92506
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8
Reviva site
Hollywood, Florida, United States, 33021
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9
Reviva site
Hollywood, Florida, United States, 33024
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10
Reviva site
Miami Lakes, Florida, United States, 33016
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11
Reviva site
Atlanta, Georgia, United States, 30331
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12
Reviva site
Decatur, Georgia, United States, 30030
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13
Reviva site
Chicago, Illinois, United States, 60641
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14
Reviva site
Gaithersburg, Maryland, United States, 20877
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15
Reviva site
Boston, Massachusetts, United States, 02114
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16
Reviva site
Oklahoma City, Oklahoma, United States, 73112
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17
Reviva site
Austin, Texas, United States, 78754
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18
Reviva site
Richardson, Texas, United States, 75080
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Research Team
M
Medical Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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