The purpose of this study is to assess the safety and effects on electrical activity in the brain of an investigational drug (RL-007) for improving cognition in patients with schizophrenia
Potential participants will first be given an Informed Consent document and have the study explained to them. All patients who provide written informed consent will undergo screening to determine eligibility for the study. Patients who meet all eligibility criteria will be admitted to the clinic for 5 days / 4 nights as an in-patient. During this time, participants will be assigned to a specific dose cohort and will receive sequence that includes both placebo and RL-007. Brain activity and cognitive performance will be assessed on study days 2 and 4.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
37
Cohorts are 10 mg, 20 mg, 40 mg, and 80 mg with TID dosing
Cohorts are 10 mg, 20 mg, 40 mg, and 80 mg with TID dosing
Collaborative Neuroscience Research
Long Beach, California, United States
Incidence of Treatment-emergent Adverse Events (TEAE)
Comparison of AE rates between active and placebo dosing
Time frame: Study Day 8.
Change in blood pressure (systolic and diastolic) from baseline
blood pressure measured in mmHg; baseline = Day -1
Time frame: Study Day 4
Change in heart rate from baseline
heart rate measured in beats per minute; baseline = Day -1
Time frame: Study Day 4
Change in respiratory rate from baseline
respiratory rate measured in breaths per minute; baseline = Day -1
Time frame: Study Day 4
Change in temperature from baseline
temperature measured in degrees Celsius; baseline = Day -1
Time frame: Study Day 4
Change in electrocardiogram (ECG) from baseline
overall physician interpretation of ECG reading; baseline = Day -1
Time frame: Study Day 3
Change in the Columbia Suicide Severity Rating Scale (C-SSRS) from baseline
The C-SSRS assesses suicidal ideation and behavior; baseline = Day -1
Time frame: Study Day 8
Change from baseline in quantitative electroencephalogram (qEEG)
change from baseline in amplitude across qEEG frequency bands (alpha, beta, delta, theta, and gamma)
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Time frame: Study Day 4
Change from baseline in evoked response potential (ERP) amplitude
Change from baseline in signal amplitude of the two-stimulus auditory oddball ERP
Time frame: Study Day 4
Change from baseline in evoked response potential (ERP) latency
Change from baseline in signal latency of the two-stimulus auditory oddball ERP
Time frame: Study Day 4
Change from baseline in amplitude of mismatch negativity (MMN) ERP
Change from baseline in signal amplitude of the MMN ERP
Time frame: Study Day 4
Change from baseline in latency of mismatch negativity (MMN) ERP
Change from baseline in signal latency of the MMN ERP
Time frame: Study Day 4