The goal of this clinical trial is to evaluate if the investigational drug, RL-007, can improve the cognitive performance of subjects with schizophrenia. The main questions the study aims to answer are: 1. Does RL-007 improve subjects performance in a set of cognitive tasks? 2. Which dose of RL-007 (20 mg or 40 mg) has a larger effect on cognitive performance? 3. How well do subjects tolerate RL-007? In the study, subjects will perform the cognitive tasks at the beginning to get familiar with the tasks. Then, subjects will be given either RL-007 or a placebo for 6 weeks and then repeat the cognitive tasks. The researchers will compare the results at the end of the treatment period to the baseline to see if there have been any changes in performance. Additionally, several safety measures will be collected throughout the study (blood pressure, physical exam, ECGs, etc) to evaluate if there are any side effects from taking RL-007.
This is a randomized, 3-arm, placebo-controlled, double-blinded clinical trial to evaluate the efficacy, safety, and tolerability of RL-007 in subjects with stable schizophrenia. The treatment period is 6 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
242
investigational study drug
placebo capsules matching the appearance and size of the active drug
Recognify Research Site
Culver City, California, United States
Collaborative Neuroscience Research
Garden Grove, California, United States
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Lafayette, California, United States
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Oceanside, California, United States
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Orange, California, United States
MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite
change from baseline in composite of nine cognitive tests
Time frame: 6 weeks
Symbol Coding
change from baseline
Time frame: 6 weeks
The Speed of Processing domain of the MCCB
change from baseline
Time frame: 6 weeks
The Attention/Vigilance domain of the MCCB
change from baseline
Time frame: 6 weeks
The Working Memory domain of the MCCB
change from baseline
Time frame: 6 weeks
The Verbal Memory domain of the MCCB
change from baseline
Time frame: 6 weeks
The Visual Learning domain of the MCCB
change from baseline
Time frame: 6 weeks
The Reasoning and Problem-solving domain of the MCCB
change from baseline
Time frame: 6 weeks
Clinical Global Impression - Severity (CGI-S)
change from baseline
Time frame: 6 weeks
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Torrance, California, United States
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Hialeah, Florida, United States
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Miami, Florida, United States
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Miami Lakes, Florida, United States
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Atlanta, Georgia, United States
...and 26 more locations